Shengdi Lu
Current Organizations / Institutes
The organizations/institutes from the scholar's latest article
Shengdi Lu has a total of 200 co-authors. Here are the top co-authors by number of shared publications:
- Yun Shen
Pennington Biomedical Research Center
15 shared publications Lihua Huang
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
12 shared publications- Lihua Huang
Department of Rehabilitation, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, China
8 shared publications - Jian Ding
Department of Orthopaedics, Shanghai Sixth People’s Hospital, Shanghai, China
7 shared publications Ruixin Wang
School of Public Health, Fudan University
7 shared publications- Yanmao Wang
Department of Orthopedics, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China
7 shared publications
Latest Publications
- Open Access
- 20 October 2026
- Published by Frontiers Media SA in Frontiers in Nephrology
- Vol. 6, 1930977
Combination finerenone and empagliflozin for chronic kidney disease with type 2 diabetes: a target trial emulation
Objective: This study aims to emulate the CONFIDENCE trial and compare combination finerenone plus empagliflozin with each monotherapy for albuminuria reduction in Chinese patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). Design: This study employed modified target trial emulation. The primary contrast was the per-protocol effect, estimated by cloning, censoring, and inverse probability of censoring weighting, which is not susceptible to grace-period immortal time bias; a propensity-score-matched assignment analysis, the observational analogue of intention-to-treat, was secondary. Setting: Electronic health records from three Chinese tertiary (Grade A) hospitals, from January 2023 to September 2025, were utilized. Participants: A total of 2,895 adults (965 per strategy) with CKD and T2D met the CONFIDENCE eligibility criteria, selected by 1:1:1 propensity score matching from 3,822 eligible patients. Main outcome measures: Relative change in urine albumin-to-creatinine ratio (UACR) from baseline to day 180 was the main outcome measure (co-primary comparisons with Holm–Bonferroni correction). Results: At day 180, the median UACR reduction was 52.0% in the combination strategy, 32.1% with finerenone, and 28.9% with empagliflozin. In the per-protocol analysis the difference was −19.5 percentage points (95% confidence interval −20.5 to −18.5) versus finerenone and −22.8 (−23.8 to −21.8) versus empagliflozin. The secondary assignment analysis gave −19.6 (−20.5 to −18.7) and −22.9 (−23.8 to −22.0), respectively (both P < 0.001); this is not a true intention-to-treat effect and is supportive only. Hyperkalemia occurred in 12.7%, 12.8%, and 3.5%, respectively, acute kidney injury in 4.9%, 2.8%, and 2.3%, respectively, and symptomatic hypotension in 1.9%, 0.6%, and 0.4%, respectively. The findings were consistent across 10 sensitivity analyses and six subgroups. Conclusions: Combination finerenone and empagliflozin was associated with greater albuminuria reduction than either monotherapy, directionally consistent with CONFIDENCE. Because the emulated strategy permitted sequential initiation within 90 days whereas CONFIDENCE randomized simultaneous initiation, this is a modified emulation rather than a direct replication. Albuminuria is a surrogate endpoint and follow-up was 180 days, so hard kidney and cardiovascular outcomes remain unstudied. Despite loss to follow-up of 29.6% to 32.7%, the finding was robust in a tipping-point analysis. Hyperkalemia was frequent with finerenone, so biochemical monitoring remains necessary. Findings apply to comparable Chinese tertiary-care populations.
- 20 October 2026
- Published by Frontiers Media SA in Frontiers in Nephrology
- Vol. 6, 1930977
Open AccessCombination finerenone and empagliflozin for chronic kidney disease with type 2 diabetes: a target trial emulation
Objective: This study aims to emulate the CONFIDENCE trial and compare combination finerenone plus empagliflozin with each monotherapy for albuminuria reduction in Chinese patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). Design: This study employed modified target trial emulation. The primary contrast was the per-protocol effect, estimated by cloning, censoring, and inverse probability of censoring weighting, which is not susceptible to grace-period immortal time bias; a propensity-score-matched assignment analysis, the observational analogue of intention-to-treat, was secondary. Setting: Electronic health records from three Chinese tertiary (Grade A) hospitals, from January 2023 to September 2025, were utilized. Participants: A total of 2,895 adults (965 per strategy) with CKD and T2D met the CONFIDENCE eligibility criteria, selected by 1:1:1 propensity score matching from 3,822 eligible patients. Main outcome measures: Relative change in urine albumin-to-creatinine ratio (UACR) from baseline to day 180 was the main outcome measure (co-primary comparisons with Holm–Bonferroni correction). Results: At day 180, the median UACR reduction was 52.0% in the combination strategy, 32.1% with finerenone, and 28.9% with empagliflozin. In the per-protocol analysis the difference was −19.5 percentage points (95% confidence interval −20.5 to −18.5) versus finerenone and −22.8 (−23.8 to −21.8) versus empagliflozin. The secondary assignment analysis gave −19.6 (−20.5 to −18.7) and −22.9 (−23.8 to −22.0), respectively (both P < 0.001); this is not a true intention-to-treat effect and is supportive only. Hyperkalemia occurred in 12.7%, 12.8%, and 3.5%, respectively, acute kidney injury in 4.9%, 2.8%, and 2.3%, respectively, and symptomatic hypotension in 1.9%, 0.6%, and 0.4%, respectively. The findings were consistent across 10 sensitivity analyses and six subgroups. Conclusions: Combination finerenone and empagliflozin was associated with greater albuminuria reduction than either monotherapy, directionally consistent with CONFIDENCE. Because the emulated strategy permitted sequential initiation within 90 days whereas CONFIDENCE randomized simultaneous initiation, this is a modified emulation rather than a direct replication. Albuminuria is a surrogate endpoint and follow-up was 180 days, so hard kidney and cardiovascular outcomes remain unstudied. Despite loss to follow-up of 29.6% to 32.7%, the finding was robust in a tipping-point analysis. Hyperkalemia was frequent with finerenone, so biochemical monitoring remains necessary. Findings apply to comparable Chinese tertiary-care populations.
- 14 October 2026
- Published by Wiley in European journal of pain
- Vol. 30 (9) , e70422
Hospital Anxiety and Depression Scale Trajectories and Risk of Complex Regional Pain Syndrome in Middle‐Aged Women After Surgical Treatment of Acute Distal Radial Fracture: A Prospective Longitudinal Cohort Study
Objective: To identify Hospital Anxiety and Depression Scale–Anxiety (HADS‐A) trajectories after surgical treatment of distal radius fracture (DRF) in middle‐aged women, and their association with complex regional pain syndrome (CRPS). Design: Prospective longitudinal cohort study. Setting: Tertiary hospital, China. Participants: One thousand eight hundred seventy‐five consecutive women aged 40–65 years undergoing surgical fixation of acute unilateral DRF (January 2019–December 2022). Main Outcome Measures: Primary outcome was CRPS diagnosed by the Budapest Clinical Criteria at 3 months. HADS‐A was measured at baseline and 1, 2, 3 and 6 months, with CRPS assessed at each follow‐up. Latent class trajectory modelling (LCTM) defined trajectory classes; time in target range (TTR) was the proportion of assessments with HADS‐A < 8. Results: During 6‐month follow‐up, 150 women (8.0%) developed CRPS. LCTM identified four trajectories: low‐stable ( n = 983, 52.4%), moderate‐recovering ( n = 448, 23.9%), high‐persistent ( n = 265, 14.1%) and delayed‐onset ( n = 179, 9.5%). Incidence was 19.2% (high‐persistent) versus 4.9% (low‐stable). After adjustment, the high‐persistent trajectory was associated with CRPS (odds ratio [OR] 4.85, 95% confidence interval [CI] 1.85–12.71; p = 0.001). TTR showed a graded exposure–response relationship: 0% versus 100% TTR carried higher risk (adjusted OR: 4.97, 95% CI: 2.51–9.86; p < 0.001; p for trend < 0.001). Subgroup interactions were non‐significant. Conclusions: Persistently elevated postoperative anxiety, rather than transient distress confined to the perioperative period, was associated with CRPS after DRF surgery, with a graded exposure–response relationship between cumulative anxiety burden (HADS‐A TTR) and risk. Serial psychological monitoring beyond baseline may help identify at‐risk patients. Significance Statement: This study provides the first evidence that longitudinal anxiety trajectory patterns, not single‐timepoint assessments, independently predict complex regional pain syndrome after distal radius fracture surgery. By introducing the “time in target range” concept to psychological measurement, we demonstrate a dose–response relationship between cumulative anxiety burden and CRPS risk. These findings reframe the longstanding debate on psychological contributors to CRPS and support serial anxiety monitoring as a clinically actionable strategy for early identification of at‐risk patients.
- 14 October 2026
- Published by Wiley in European journal of pain
- Vol. 30 (9) , e70422
Hospital Anxiety and Depression Scale Trajectories and Risk of Complex Regional Pain Syndrome in Middle‐Aged Women After Surgical Treatment of Acute Distal Radial Fracture: A Prospective Longitudinal Cohort Study
Objective: To identify Hospital Anxiety and Depression Scale–Anxiety (HADS‐A) trajectories after surgical treatment of distal radius fracture (DRF) in middle‐aged women, and their association with complex regional pain syndrome (CRPS). Design: Prospective longitudinal cohort study. Setting: Tertiary hospital, China. Participants: One thousand eight hundred seventy‐five consecutive women aged 40–65 years undergoing surgical fixation of acute unilateral DRF (January 2019–December 2022). Main Outcome Measures: Primary outcome was CRPS diagnosed by the Budapest Clinical Criteria at 3 months. HADS‐A was measured at baseline and 1, 2, 3 and 6 months, with CRPS assessed at each follow‐up. Latent class trajectory modelling (LCTM) defined trajectory classes; time in target range (TTR) was the proportion of assessments with HADS‐A < 8. Results: During 6‐month follow‐up, 150 women (8.0%) developed CRPS. LCTM identified four trajectories: low‐stable ( n = 983, 52.4%), moderate‐recovering ( n = 448, 23.9%), high‐persistent ( n = 265, 14.1%) and delayed‐onset ( n = 179, 9.5%). Incidence was 19.2% (high‐persistent) versus 4.9% (low‐stable). After adjustment, the high‐persistent trajectory was associated with CRPS (odds ratio [OR] 4.85, 95% confidence interval [CI] 1.85–12.71; p = 0.001). TTR showed a graded exposure–response relationship: 0% versus 100% TTR carried higher risk (adjusted OR: 4.97, 95% CI: 2.51–9.86; p < 0.001; p for trend < 0.001). Subgroup interactions were non‐significant. Conclusions: Persistently elevated postoperative anxiety, rather than transient distress confined to the perioperative period, was associated with CRPS after DRF surgery, with a graded exposure–response relationship between cumulative anxiety burden (HADS‐A TTR) and risk. Serial psychological monitoring beyond baseline may help identify at‐risk patients. Significance Statement: This study provides the first evidence that longitudinal anxiety trajectory patterns, not single‐timepoint assessments, independently predict complex regional pain syndrome after distal radius fracture surgery. By introducing the “time in target range” concept to psychological measurement, we demonstrate a dose–response relationship between cumulative anxiety burden and CRPS risk. These findings reframe the longstanding debate on psychological contributors to CRPS and support serial anxiety monitoring as a clinically actionable strategy for early identification of at‐risk patients.
- 13 October 2026
- Published by Wolters Kluwer Health in Annals of Plastic Surgery
Clinical Practice Guideline of Surgical Treatment of Segmental Bone Defects After Open Tibia Diaphyseal Fracture
Purpose: Segmental tibial diaphyseal bone defects after open fracture are difficult to treat and require timely, coordinated reconstruction. We aimed to develop evidence-based surgical guidelines based on meta-analysis and consensus recommendations from an expert committee of orthopedic surgeons. Methods: Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guideline, we searched 5 databases (1989 to 2024) for studies evaluating surgical treatment of post-traumatic tibial diaphyseal segmental defects. Random-effects models pooled union rate, union time, and complication rate across 4 techniques (Ilizarov bone transport [IBT], free vascularized bone grafting [FVBG], nonvascularized autografting [AG], and the Masquelet technique [MT]). Consensus recommendations were developed using a Delphi process. Results: Twenty-eight studies, including 824 patients (824 tibias) were analyzed: IBT (11 studies; n=361), FVBG (4; n=68), AG (10; n=164), and MT (6; n=67). Pooled union rates were 96% (IBT), 95% (FVBG), 95% (AG), and 81% (MT). Mean pooled union times were 33.04 weeks (IBT), 37.81 (FVBG), 29.73 (AG), and 29.74 (MT). Pooled complication rates were 82% (IBT), 94% (FVBG), 44% (AG), and 53% (MT). Conclusion: On the basis of the evidence and expert consensus, early operative management with prompt stabilization and antimicrobial therapy, supported by multidisciplinary care, is recommended. For large or complex defects, IBT and FVBG are generally preferred, while AG and MT remain options in selected scenarios. Outcomes depend on early intervention, appropriate technique selection, and structured rehabilitation; further high-quality studies are needed to validate these recommendations.
- 13 October 2026
- Published by Wolters Kluwer Health in Annals of Plastic Surgery
Clinical Practice Guideline of Surgical Treatment of Segmental Bone Defects After Open Tibia Diaphyseal Fracture
Purpose: Segmental tibial diaphyseal bone defects after open fracture are difficult to treat and require timely, coordinated reconstruction. We aimed to develop evidence-based surgical guidelines based on meta-analysis and consensus recommendations from an expert committee of orthopedic surgeons. Methods: Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guideline, we searched 5 databases (1989 to 2024) for studies evaluating surgical treatment of post-traumatic tibial diaphyseal segmental defects. Random-effects models pooled union rate, union time, and complication rate across 4 techniques (Ilizarov bone transport [IBT], free vascularized bone grafting [FVBG], nonvascularized autografting [AG], and the Masquelet technique [MT]). Consensus recommendations were developed using a Delphi process. Results: Twenty-eight studies, including 824 patients (824 tibias) were analyzed: IBT (11 studies; n=361), FVBG (4; n=68), AG (10; n=164), and MT (6; n=67). Pooled union rates were 96% (IBT), 95% (FVBG), 95% (AG), and 81% (MT). Mean pooled union times were 33.04 weeks (IBT), 37.81 (FVBG), 29.73 (AG), and 29.74 (MT). Pooled complication rates were 82% (IBT), 94% (FVBG), 44% (AG), and 53% (MT). Conclusion: On the basis of the evidence and expert consensus, early operative management with prompt stabilization and antimicrobial therapy, supported by multidisciplinary care, is recommended. For large or complex defects, IBT and FVBG are generally preferred, while AG and MT remain options in selected scenarios. Outcomes depend on early intervention, appropriate technique selection, and structured rehabilitation; further high-quality studies are needed to validate these recommendations.
- Open Access
- 13 October 2026
- Published by Cambridge University Press (CUP) in Epidemiology and Psychiatric Sciences
- Vol. 35, e69
Composite sleep score and risk of psychiatric disorders via proteomic features in preclinical obesity: a prospective cohort study from the UK Biobank
Aims: Sleep disturbances are linked to psychiatric disorders, and obesity is associated with a higher risk of several psychiatric disorders. However, evidence is lacking on how a composite sleep score relates to psychiatric disorder risk in preclinical obesity and on the proteomic pathways that mediate this relationship. Our study aimed to investigate the association of composite sleep score and the risk of multiple specific psychiatric disorders in participants with preclinical obesity. Methods: The prospective cohort study from the UK Biobank included 91,380 participants with preclinical obesity. Six groups were categorized according to sleep scores. Hazard ratios (HRs) for the incidence risk of psychiatric disorders were estimated using multiple Cox proportional hazards regression analysis. Mediation analysis of plasma proteomics in this association was conducted in a subset of participants ( n = 9,486). Results: After a mean follow-up period of 12.9 years, a total of 8,992 incident cases of psychiatric disorders were observed. Using Group 1 as the reference, the risk of psychiatric disorders decreased significantly across Groups 2–6 with increasing sleep score, reaching the lowest in Group 6 (fully adjusted HR = 0.47, 95% CI: 0.33–0.67). Analyses of specific psychiatric disorders revealed that the inverse associations remained significant after full adjustment, with the most notable effect observed for attention deficit hyperactivity disorder (HR = 0.24, 95% CI: 0.08–0.72). Mediation analysis further identified 16 plasma proteins that exerted significant partial mediating effects in this association. Conclusions: Our findings underscore that better sleep quality is associated with a lower risk of psychiatric disorders among individuals with preclinical obesity. The identification of proteomic mediators may provide further insight into the underlying biological mechanisms, highlighting the clinical significance of integrating sleep-related assessment and intervention.
- 13 October 2026
- Published by Cambridge University Press (CUP) in Epidemiology and Psychiatric Sciences
- Vol. 35, e69
Open AccessComposite sleep score and risk of psychiatric disorders via proteomic features in preclinical obesity: a prospective cohort study from the UK Biobank
Aims: Sleep disturbances are linked to psychiatric disorders, and obesity is associated with a higher risk of several psychiatric disorders. However, evidence is lacking on how a composite sleep score relates to psychiatric disorder risk in preclinical obesity and on the proteomic pathways that mediate this relationship. Our study aimed to investigate the association of composite sleep score and the risk of multiple specific psychiatric disorders in participants with preclinical obesity. Methods: The prospective cohort study from the UK Biobank included 91,380 participants with preclinical obesity. Six groups were categorized according to sleep scores. Hazard ratios (HRs) for the incidence risk of psychiatric disorders were estimated using multiple Cox proportional hazards regression analysis. Mediation analysis of plasma proteomics in this association was conducted in a subset of participants ( n = 9,486). Results: After a mean follow-up period of 12.9 years, a total of 8,992 incident cases of psychiatric disorders were observed. Using Group 1 as the reference, the risk of psychiatric disorders decreased significantly across Groups 2–6 with increasing sleep score, reaching the lowest in Group 6 (fully adjusted HR = 0.47, 95% CI: 0.33–0.67). Analyses of specific psychiatric disorders revealed that the inverse associations remained significant after full adjustment, with the most notable effect observed for attention deficit hyperactivity disorder (HR = 0.24, 95% CI: 0.08–0.72). Mediation analysis further identified 16 plasma proteins that exerted significant partial mediating effects in this association. Conclusions: Our findings underscore that better sleep quality is associated with a lower risk of psychiatric disorders among individuals with preclinical obesity. The identification of proteomic mediators may provide further insight into the underlying biological mechanisms, highlighting the clinical significance of integrating sleep-related assessment and intervention.
- Open Access
- 6 September 2026
- Published by Springer Nature in Archives of orthopaedic and trauma surgery
- Vol. 146 (1) , 327
Comparative effectiveness of single-stage versus two-stage revision for hip prosthetic joint infection: emulation of the INFORM target trial using electronic health record data
Objective To estimate the comparative effectiveness of single-stage versus two-stage revision for hip prosthetic joint infection (PJI) in Chinese tertiary hospitals by emulating the INFORM randomized trial using the target trial emulation framework. Design Retrospective cohort study emulating a target trial, reported per the TARGET guideline. The protocol and analysis plan were written before analysis but were not prospectively registered. Setting Three tertiary hospitals in China. Index revision surgeries were performed between 1 January 2018 and 30 June 2022, with follow-up data locked on 31 December 2023, ensuring a minimum potential follow-up of 18 months for every patient. Participants 754 adults with confirmed hip PJI undergoing revision surgery (280 single-stage; 474 two-stage), identified from electronic health records and confirmed by manual chart review. Treatment groups reflected the intended surgical strategy documented before or at the index operation. Main outcome measures Primary outcome: Harris Hip Score (HHS) at 18 months. Secondary outcomes: surgically treated reinfection, reoperation, mortality, and complications. The primary analysis used inverse probability of treatment weighting (IPTW) on the full cohort with multiple imputation of missing covariate and outcome data; 1:1 propensity score (PS) matching (280 pairs) was confirmatory. Patients who died before an assessment were excluded from the functional analysis at that assessment rather than having a score imputed, so the functional estimand is restricted to survivors (727 of 754 at 18 months). No a priori sample size calculation was performed because all eligible patients were included; precision is reported in place of retrospective power. Results Mean age was 60.6 (SD 14.4) years; 511 of 754 patients (67.8%) were male. Avascular necrosis was the leading indication for the primary arthroplasty (390/754, 51.7%). The adjusted mean difference in HHS at 18 months was 1.68 points (95% confidence interval [CI] − 0.12 to 3.48; P = 0.07), favoring single-stage but not reaching statistical significance; the interval is small relative to the within-person minimal clinically important improvement (MCII) for the HHS reported after primary hip arthroplasty (approximately 16 to 18 points), but that threshold describes improvement within an individual patient rather than a difference between groups, and no minimal important between-group difference has been established for this instrument in revision surgery, so we do not claim to have excluded a clinically important difference. At 3 months, single-stage was associated with a higher HHS (mean difference 5.82, 95% CI 1.43 to 10.21; P = 0.01); this early difference is attributable in part to many two-stage patients not yet having undergone reimplantation. Surgically treated reinfection was similar in frequency (13.2% v 11.8%; risk ratio [RR] 1.12, 95% CI 0.72 to 1.74). Fewer intraoperative adverse events were recorded for single-stage (RR 0.46, 95% CI 0.26 to 0.82), but this comparison is confounded by unequal operative exposure, because two-stage patients underwent two operative episodes and single-stage patients one, and it should not be read as a safety advantage of single-stage surgery. Mortality did not differ significantly (2.9% v 4.0%). The direction of the estimated difference was consistent across sensitivity analyses and no analysis was statistically significant, but the magnitude was not stable (1.18 to 2.48 points). Findings were directionally consistent with the INFORM trial, although HHS and WOMAC are distinct instruments and the estimates are not numerically comparable. Conclusions In this observational emulation, an intended single-stage strategy was associated with 18-month functional outcomes that did not differ significantly from an intended two-stage strategy. The comparison is statistically inconclusive for small differences and does not demonstrate equivalence, which was not formally tested. Because treatment was not randomized, the protocol was not prospectively registered, the magnitude of the estimate varied across model specifications, outcome ascertainment was incomplete, and the functional comparison is conditional on survival, these findings are hypothesis-generating and require confirmation in prospective, adequately powered studies before informing practice.
- 6 September 2026
- Published by Springer Nature in Archives of orthopaedic and trauma surgery
- Vol. 146 (1) , 327
Open AccessComparative effectiveness of single-stage versus two-stage revision for hip prosthetic joint infection: emulation of the INFORM target trial using electronic health record data
Objective To estimate the comparative effectiveness of single-stage versus two-stage revision for hip prosthetic joint infection (PJI) in Chinese tertiary hospitals by emulating the INFORM randomized trial using the target trial emulation framework. Design Retrospective cohort study emulating a target trial, reported per the TARGET guideline. The protocol and analysis plan were written before analysis but were not prospectively registered. Setting Three tertiary hospitals in China. Index revision surgeries were performed between 1 January 2018 and 30 June 2022, with follow-up data locked on 31 December 2023, ensuring a minimum potential follow-up of 18 months for every patient. Participants 754 adults with confirmed hip PJI undergoing revision surgery (280 single-stage; 474 two-stage), identified from electronic health records and confirmed by manual chart review. Treatment groups reflected the intended surgical strategy documented before or at the index operation. Main outcome measures Primary outcome: Harris Hip Score (HHS) at 18 months. Secondary outcomes: surgically treated reinfection, reoperation, mortality, and complications. The primary analysis used inverse probability of treatment weighting (IPTW) on the full cohort with multiple imputation of missing covariate and outcome data; 1:1 propensity score (PS) matching (280 pairs) was confirmatory. Patients who died before an assessment were excluded from the functional analysis at that assessment rather than having a score imputed, so the functional estimand is restricted to survivors (727 of 754 at 18 months). No a priori sample size calculation was performed because all eligible patients were included; precision is reported in place of retrospective power. Results Mean age was 60.6 (SD 14.4) years; 511 of 754 patients (67.8%) were male. Avascular necrosis was the leading indication for the primary arthroplasty (390/754, 51.7%). The adjusted mean difference in HHS at 18 months was 1.68 points (95% confidence interval [CI] − 0.12 to 3.48; P = 0.07), favoring single-stage but not reaching statistical significance; the interval is small relative to the within-person minimal clinically important improvement (MCII) for the HHS reported after primary hip arthroplasty (approximately 16 to 18 points), but that threshold describes improvement within an individual patient rather than a difference between groups, and no minimal important between-group difference has been established for this instrument in revision surgery, so we do not claim to have excluded a clinically important difference. At 3 months, single-stage was associated with a higher HHS (mean difference 5.82, 95% CI 1.43 to 10.21; P = 0.01); this early difference is attributable in part to many two-stage patients not yet having undergone reimplantation. Surgically treated reinfection was similar in frequency (13.2% v 11.8%; risk ratio [RR] 1.12, 95% CI 0.72 to 1.74). Fewer intraoperative adverse events were recorded for single-stage (RR 0.46, 95% CI 0.26 to 0.82), but this comparison is confounded by unequal operative exposure, because two-stage patients underwent two operative episodes and single-stage patients one, and it should not be read as a safety advantage of single-stage surgery. Mortality did not differ significantly (2.9% v 4.0%). The direction of the estimated difference was consistent across sensitivity analyses and no analysis was statistically significant, but the magnitude was not stable (1.18 to 2.48 points). Findings were directionally consistent with the INFORM trial, although HHS and WOMAC are distinct instruments and the estimates are not numerically comparable. Conclusions In this observational emulation, an intended single-stage strategy was associated with 18-month functional outcomes that did not differ significantly from an intended two-stage strategy. The comparison is statistically inconclusive for small differences and does not demonstrate equivalence, which was not formally tested. Because treatment was not randomized, the protocol was not prospectively registered, the magnitude of the estimate varied across model specifications, outcome ascertainment was incomplete, and the functional comparison is conditional on survival, these findings are hypothesis-generating and require confirmation in prospective, adequately powered studies before informing practice.
- Open Access
- 20 August 2026
- Published by Springer Nature in International Orthopaedics
- Vol. 50 (11) , 2935-2947
Efficiency and cost-effectiveness of three surgical strategies for primary osteoarthritis of the elbow: a multicenter propensity score–weighted cohort study
Background: Primary osteoarthritis of the elbow causes progressive stiffness and pain, yet no study has directly compared the efficiency and cost-effectiveness of the three principal surgical strategies: total elbow arthroplasty (TEA), open osteocapsular arthroplasty (OCA), and arthroscopic OCA. We hypothesized that joint-preserving OCA would achieve greater motion recovery at lower cost than TEA. Methods: This multicenter retrospective cohort study identified 542 patients with primary elbow OA from three Chinese Tertiary A hospitals (surgery January 2017–December 2023; minimum two year follow-up through December 2025): 142 TEA, 221 open OCA, and 179 arthroscopic OCA. Because propensity-score matching left substantial residual imbalance in age and baseline motion, primary inference was based on generalized overlap weighting, which achieved covariate balance and estimates the average treatment effect in the overlap population, that is, the sub-population in clinical equipoise [25, 40]. Matching with covariate-adjusted mixed models is reported as a supporting analysis. Co-primary outcomes were the percentage of lost motion recovered and the flexion–extension (FE) arc at two years. Because pain relief rather than motion is the principal indication for TEA, cost-effectiveness was additionally assessed on a pain axis. Willingness-to-pay thresholds were not applied, as gross-domestic-product–based thresholds are defined per quality-adjusted life year and are not commensurate with effects expressed in natural units [4, 27]. Results: Overlap weighting achieved acceptable balance (age standardized mean difference 0.11; baseline arc 0.08) with an effective sample size of 246 of 542 patients (45.4%; TEA 41, open OCA 144, arthroscopic OCA 62). In the overlap population, the percentage of lost motion recovered at 2 years was 15.8% (TEA), 35.9% (open OCA), and 32.2% (arthroscopic OCA), and the 2-year FE arc was 94.0°, 108.0°, and 104.5°. Both OCA procedures exceeded TEA by 16–20 percentage points of lost motion recovered, whereas the difference between the two OCA approaches was below the minimal clinically important difference. On the pain axis, visual analog scale reduction was 1.93, 2.44, and 2.77 points; all between-group differences (0.33–0.84) fell below the 1.4-point minimal clinically important difference, indicating clinically equivalent pain relief. Overlap-weighted total costs were ¥86,728 (TEA), ¥32,503 (open OCA), and ¥24,677 (arthroscopic OCA). TEA therefore cost approximately ¥62,000 more per patient than arthroscopic OCA without a clinically important advantage on either axis. Corrected complication rates in the TEA group were radiographic aseptic loosening 13.6%, loosening requiring revision 8.2%, and revision surgery 9.4%, consistent with published mid-term series. Conclusions: Within the sub-population in clinical equipoise, joint-preserving OCA recovered more motion than TEA at substantially lower cost, while pain relief was clinically equivalent across all three strategies. These findings describe real-world treatment strategies applied to their usual indications and should not be read as evidence that TEA and OCA are interchangeable, nor as a general first-line recommendation: patients with end-stage ulnohumeral destruction, for whom TEA is indicated, are under-represented in the overlap population. For patients in whom both joint preservation and arthroplasty are genuinely being considered, OCA appears the more efficient choice.
- 20 August 2026
- Published by Springer Nature in International Orthopaedics
- Vol. 50 (11) , 2935-2947
Open AccessEfficiency and cost-effectiveness of three surgical strategies for primary osteoarthritis of the elbow: a multicenter propensity score–weighted cohort study
Background: Primary osteoarthritis of the elbow causes progressive stiffness and pain, yet no study has directly compared the efficiency and cost-effectiveness of the three principal surgical strategies: total elbow arthroplasty (TEA), open osteocapsular arthroplasty (OCA), and arthroscopic OCA. We hypothesized that joint-preserving OCA would achieve greater motion recovery at lower cost than TEA. Methods: This multicenter retrospective cohort study identified 542 patients with primary elbow OA from three Chinese Tertiary A hospitals (surgery January 2017–December 2023; minimum two year follow-up through December 2025): 142 TEA, 221 open OCA, and 179 arthroscopic OCA. Because propensity-score matching left substantial residual imbalance in age and baseline motion, primary inference was based on generalized overlap weighting, which achieved covariate balance and estimates the average treatment effect in the overlap population, that is, the sub-population in clinical equipoise [25, 40]. Matching with covariate-adjusted mixed models is reported as a supporting analysis. Co-primary outcomes were the percentage of lost motion recovered and the flexion–extension (FE) arc at two years. Because pain relief rather than motion is the principal indication for TEA, cost-effectiveness was additionally assessed on a pain axis. Willingness-to-pay thresholds were not applied, as gross-domestic-product–based thresholds are defined per quality-adjusted life year and are not commensurate with effects expressed in natural units [4, 27]. Results: Overlap weighting achieved acceptable balance (age standardized mean difference 0.11; baseline arc 0.08) with an effective sample size of 246 of 542 patients (45.4%; TEA 41, open OCA 144, arthroscopic OCA 62). In the overlap population, the percentage of lost motion recovered at 2 years was 15.8% (TEA), 35.9% (open OCA), and 32.2% (arthroscopic OCA), and the 2-year FE arc was 94.0°, 108.0°, and 104.5°. Both OCA procedures exceeded TEA by 16–20 percentage points of lost motion recovered, whereas the difference between the two OCA approaches was below the minimal clinically important difference. On the pain axis, visual analog scale reduction was 1.93, 2.44, and 2.77 points; all between-group differences (0.33–0.84) fell below the 1.4-point minimal clinically important difference, indicating clinically equivalent pain relief. Overlap-weighted total costs were ¥86,728 (TEA), ¥32,503 (open OCA), and ¥24,677 (arthroscopic OCA). TEA therefore cost approximately ¥62,000 more per patient than arthroscopic OCA without a clinically important advantage on either axis. Corrected complication rates in the TEA group were radiographic aseptic loosening 13.6%, loosening requiring revision 8.2%, and revision surgery 9.4%, consistent with published mid-term series. Conclusions: Within the sub-population in clinical equipoise, joint-preserving OCA recovered more motion than TEA at substantially lower cost, while pain relief was clinically equivalent across all three strategies. These findings describe real-world treatment strategies applied to their usual indications and should not be read as evidence that TEA and OCA are interchangeable, nor as a general first-line recommendation: patients with end-stage ulnohumeral destruction, for whom TEA is indicated, are under-represented in the overlap population. For patients in whom both joint preservation and arthroplasty are genuinely being considered, OCA appears the more efficient choice.
- Open Access
- 14 August 2026
- Published by Frontiers Media SA in Frontiers in Cardiovascular Medicine
- Vol. 13, 1785484
Efficacy and costs of combined balloon dilation plus atherectomy versus combined balloon dilation plus stent for lower-limb peripheral arterial disease: a single-center propensity-matched retrospective cohort study
Objectives: To compare one-year vessel patency, limb perfusion and function, and direct and indirect costs between combined balloon angioplasty with rotational atherectomy versus balloon angioplasty with drug-eluting stent placement in patients with lower-limb peripheral arterial disease. Design: Single-center retrospective cohort study. Methods: Patients treated between January 2020 and December 2023 with atherectomy plus balloon angioplasty (AB group) were propensity-score-matched 1:1 to patients treated with balloon angioplasty plus a paclitaxel-eluting nitinol stent (BS group). The matched cohort included 160 patients per group. The primary outcome was 12-month primary vessel patency. Secondary outcomes were target vessel re-occlusion, ankle-brachial index (ABI), six-minute walk distance, Rutherford classification, disease-specific quality of life (Peripheral Artery Questionnaire, PAQ), major adverse cardiovascular events, and direct and indirect costs at one year. Results: In the matched cohort, 12-month primary patency was similarly high in both groups. Re-occlusion rates were comparable. The adjusted between-group ABI difference at 12 months was 0.010 (95% confidence interval −0.000 to 0.019; p = 0.060). The mean 6-minute walk distance improved by 121.1 m (AB) versus 122.5 m (BS) ( p = 0.867). Rutherford category and PAQ score improved similarly in both groups (PAQ increase 25.6 vs. 26.2, p = 0.593). Major adverse cardiovascular events were rare [2 patients (1.3%) in each group by 3 months, none thereafter]. Mean total cost over one year was significantly lower in the AB group (93,189 CNY) than in the BS group (119,702 CNY; p < 0.001), driven by lower device/implant costs (27,574 vs. 54,536 CNY; p < 0.001). Conclusions: Atherectomy plus angioplasty was associated with 12-month patency and functional outcomes for which no significant difference from balloon angioplasty with drug-eluting stenting was detected, at significantly lower one-year cost. Because the design was powered for superiority rather than non-inferiority, these findings indicate absence of evidence of a difference rather than proven equivalence. The cost difference was driven almost entirely by the lower device price of the atherectomy-based strategy. Level of evidence: Therapeutic, Level III (retrospective matched cohort).
- 14 August 2026
- Published by Frontiers Media SA in Frontiers in Cardiovascular Medicine
- Vol. 13, 1785484
Open AccessEfficacy and costs of combined balloon dilation plus atherectomy versus combined balloon dilation plus stent for lower-limb peripheral arterial disease: a single-center propensity-matched retrospective cohort study
Objectives: To compare one-year vessel patency, limb perfusion and function, and direct and indirect costs between combined balloon angioplasty with rotational atherectomy versus balloon angioplasty with drug-eluting stent placement in patients with lower-limb peripheral arterial disease. Design: Single-center retrospective cohort study. Methods: Patients treated between January 2020 and December 2023 with atherectomy plus balloon angioplasty (AB group) were propensity-score-matched 1:1 to patients treated with balloon angioplasty plus a paclitaxel-eluting nitinol stent (BS group). The matched cohort included 160 patients per group. The primary outcome was 12-month primary vessel patency. Secondary outcomes were target vessel re-occlusion, ankle-brachial index (ABI), six-minute walk distance, Rutherford classification, disease-specific quality of life (Peripheral Artery Questionnaire, PAQ), major adverse cardiovascular events, and direct and indirect costs at one year. Results: In the matched cohort, 12-month primary patency was similarly high in both groups. Re-occlusion rates were comparable. The adjusted between-group ABI difference at 12 months was 0.010 (95% confidence interval −0.000 to 0.019; p = 0.060). The mean 6-minute walk distance improved by 121.1 m (AB) versus 122.5 m (BS) ( p = 0.867). Rutherford category and PAQ score improved similarly in both groups (PAQ increase 25.6 vs. 26.2, p = 0.593). Major adverse cardiovascular events were rare [2 patients (1.3%) in each group by 3 months, none thereafter]. Mean total cost over one year was significantly lower in the AB group (93,189 CNY) than in the BS group (119,702 CNY; p < 0.001), driven by lower device/implant costs (27,574 vs. 54,536 CNY; p < 0.001). Conclusions: Atherectomy plus angioplasty was associated with 12-month patency and functional outcomes for which no significant difference from balloon angioplasty with drug-eluting stenting was detected, at significantly lower one-year cost. Because the design was powered for superiority rather than non-inferiority, these findings indicate absence of evidence of a difference rather than proven equivalence. The cost difference was driven almost entirely by the lower device price of the atherectomy-based strategy. Level of evidence: Therapeutic, Level III (retrospective matched cohort).
- Open Access
- 11 August 2026
- Published by Frontiers Media SA in Frontiers in Nutrition
- Vol. 13, 1806413
Glucosamine for knee osteoarthritis: an umbrella review
Background: Knee osteoarthritis (OA) is a common cause of pain and disability without a cure. Glucosamine is widely used as a symptomatic treatment owing to its safety, yet its clinical efficacy remains uncertain amid mixed trial results and conflicting guidelines. This umbrella review synthesized evidence from published systematic reviews and meta-analyses on the effectiveness and safety of glucosamine in knee OA. Methods: We searched MEDLINE (via PubMed), Embase, Web of Science, and the Cochrane Library up to November 2025. Eligible studies were systematic reviews or meta-analyses of randomized trials in adults with knee OA comparing glucosamine (any formulation) with placebo or other non-surgical comparators and reporting pain, physical function, or joint structure. Two reviewers independently screened, extracted data, and assessed quality (AMSTAR-2). Key outcomes were pain (visual analog scale [VAS] and WOMAC [Western Ontario and McMaster Universities Osteoarthritis Index]), functional measures, joint space narrowing (JSN), and adverse events. Overlap among shared primary trials was quantified using the corrected covered area, and the resulting dependence was addressed using robust variance estimation to pool standardized mean differences (SMDs), with p < 0.05 considered significant. Effect sizes were interpreted against minimal clinically important difference (MCID) thresholds. Results: Nineteen reviews were included (most low or critically low quality). Glucosamine produced a small but statistically significant reduction in VAS pain (SMD − 0.36, p = 0.02), whereas WOMAC pain showed no significant difference. Functional outcomes (WOMAC total and function) showed no significant improvement. Glucosamine was associated with significant slowing of JSN progression (SMD − 0.32, p = 0.01), though this signal derived mainly from long-duration sulfate trials. The magnitude of the significant effects was at or below accepted MCID thresholds. Adverse event rates did not differ from placebo. Conclusion: Glucosamine demonstrated at most minimal-to-modest efficacy for knee OA, yielding a small pain reduction and possible slowing of radiographic progression but no clear functional benefit, with effects at or below the threshold of clinical importance. Given the low quality of evidence, extensive overlap among reviews, and the predominantly out-of-pocket nature of glucosamine use, these findings should be interpreted with caution and weighed against cost in shared decision-making. Systematic review registration: https://www.crd.york.ac.uk/prospero/ , identifier (CRD420251207513).
- 11 August 2026
- Published by Frontiers Media SA in Frontiers in Nutrition
- Vol. 13, 1806413
Open AccessGlucosamine for knee osteoarthritis: an umbrella review
Background: Knee osteoarthritis (OA) is a common cause of pain and disability without a cure. Glucosamine is widely used as a symptomatic treatment owing to its safety, yet its clinical efficacy remains uncertain amid mixed trial results and conflicting guidelines. This umbrella review synthesized evidence from published systematic reviews and meta-analyses on the effectiveness and safety of glucosamine in knee OA. Methods: We searched MEDLINE (via PubMed), Embase, Web of Science, and the Cochrane Library up to November 2025. Eligible studies were systematic reviews or meta-analyses of randomized trials in adults with knee OA comparing glucosamine (any formulation) with placebo or other non-surgical comparators and reporting pain, physical function, or joint structure. Two reviewers independently screened, extracted data, and assessed quality (AMSTAR-2). Key outcomes were pain (visual analog scale [VAS] and WOMAC [Western Ontario and McMaster Universities Osteoarthritis Index]), functional measures, joint space narrowing (JSN), and adverse events. Overlap among shared primary trials was quantified using the corrected covered area, and the resulting dependence was addressed using robust variance estimation to pool standardized mean differences (SMDs), with p < 0.05 considered significant. Effect sizes were interpreted against minimal clinically important difference (MCID) thresholds. Results: Nineteen reviews were included (most low or critically low quality). Glucosamine produced a small but statistically significant reduction in VAS pain (SMD − 0.36, p = 0.02), whereas WOMAC pain showed no significant difference. Functional outcomes (WOMAC total and function) showed no significant improvement. Glucosamine was associated with significant slowing of JSN progression (SMD − 0.32, p = 0.01), though this signal derived mainly from long-duration sulfate trials. The magnitude of the significant effects was at or below accepted MCID thresholds. Adverse event rates did not differ from placebo. Conclusion: Glucosamine demonstrated at most minimal-to-modest efficacy for knee OA, yielding a small pain reduction and possible slowing of radiographic progression but no clear functional benefit, with effects at or below the threshold of clinical importance. Given the low quality of evidence, extensive overlap among reviews, and the predominantly out-of-pocket nature of glucosamine use, these findings should be interpreted with caution and weighed against cost in shared decision-making. Systematic review registration: https://www.crd.york.ac.uk/prospero/ , identifier (CRD420251207513).
- Open Access
- 25 July 2026
- Published by Wiley in Orthopaedic Surgery
- Vol. 18 (9) , 1958-1971
Cost‐Effectiveness Analysis of Surgical Treatment of Varus Knee Osteoarthritis for Middle‐Aged Patients: A Multicenter Retrospective Cohort Study With Over 10‐Year Follow‐Up
Background: Knee osteoarthritis with medial‐compartment varus deformity is common in middle‐aged adults, and the optimal surgical strategy for this group remains debated, with open‐wedge high tibial osteotomy (OWHTO) and total knee arthroplasty (TKA) representing joint‐preserving and joint‐replacing options whose comparative long‐term value is uncertain. Objective: To compare the cost‐effectiveness and long‐term outcomes of open‐wedge high tibial osteotomy (OWHTO) versus total knee arthroplasty (TKA) in middle‐aged patients with varus knee osteoarthritis: Methods: This multicenter retrospective cohort study analyzed registry data from three Chinese university affiliated hospitals. A total of 825 patients aged 45–65 who underwent OWHTO or TKA between 2005 and 2015 were included, with follow‐up through 2025. Outcomes included Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores, EQ‐5D‐5L utilities, range of motion (ROM), mechanical axis deviation (MAD), muscle strength, and total healthcare costs. Costs were assessed from a societal perspective (direct medical, direct non‐medical, and indirect productivity costs), and both costs and health outcomes were discounted at 3% annually. The EQ‐5D‐5L–based quality‐adjusted life year (QALY) was the primary outcome; clinical and functional measures were secondary. Multivariate regression models were used to compare outcomes between groups, and 1000‐bootstrap simulations were used to estimate incremental cost‐effectiveness ratios (ICERs). ICERs were interpreted against a willingness‐to‐pay threshold of one to three times China's 2024 gross domestic product per capita (CNY 95,749–287,247 per QALY). Robustness was assessed with inverse‐probability‐of‐treatment‐weighting (IPTW) and age‐stratified (45–54 vs. 55–65 years) sensitivity analyses. Results: Clinical outcomes at final follow‐up did not differ significantly between OWHTO and TKA groups. OWHTO was associated with a lower cumulative cost (mean CNY 121,784) than TKA (CNY 160,075; p < 0.001). In cost‐effectiveness analyses, OWHTO was associated with better outcomes in WOMAC pain, mechanical alignment (MAD), ROM, and dynamic strength at a lower cost than TKA. Quality‐adjusted life year outcomes (EQ‐5D‐5L utility) slightly favored TKA (71.9% of bootstrap samples), yielding an ICER of CNY 5,441,410.25 per QALY for TKA relative to OWHTO, approximately 19 times the upper willingness‐to‐pay threshold (3× GDP per capita, CNY 287,247 per QALY), indicating that the marginal utility gain with TKA was not cost‐effective. The reoperation/revision rate did not differ between groups (OWHTO 0.95% [3/316] vs. TKA 0.59% [3/509]; p = 0.687), and findings were consistent in IPTW‐weighted and age‐stratified sensitivity analyses. Other ICERs were 146,719.91 CNY (WOMAC function), 53,934.07 CNY (WOMAC stiffness), 115,812.43 CNY (isometric strength), and 167,518.20 CNY (sit‐to‐stand power). Results were robust to sensitivity analyses. Conclusion: Over more than 10 years of follow‐up, OWHTO provided outcomes equivalent to TKA while substantially reducing costs. These findings support OWHTO as a cost‐effective option for selected middle‐aged patients with varus knee osteoarthritis. Level of Evidence: Level III, retrospective cohort study.
- 25 July 2026
- Published by Wiley in Orthopaedic Surgery
- Vol. 18 (9) , 1958-1971
Open AccessCost‐Effectiveness Analysis of Surgical Treatment of Varus Knee Osteoarthritis for Middle‐Aged Patients: A Multicenter Retrospective Cohort Study With Over 10‐Year Follow‐Up
Background: Knee osteoarthritis with medial‐compartment varus deformity is common in middle‐aged adults, and the optimal surgical strategy for this group remains debated, with open‐wedge high tibial osteotomy (OWHTO) and total knee arthroplasty (TKA) representing joint‐preserving and joint‐replacing options whose comparative long‐term value is uncertain. Objective: To compare the cost‐effectiveness and long‐term outcomes of open‐wedge high tibial osteotomy (OWHTO) versus total knee arthroplasty (TKA) in middle‐aged patients with varus knee osteoarthritis: Methods: This multicenter retrospective cohort study analyzed registry data from three Chinese university affiliated hospitals. A total of 825 patients aged 45–65 who underwent OWHTO or TKA between 2005 and 2015 were included, with follow‐up through 2025. Outcomes included Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores, EQ‐5D‐5L utilities, range of motion (ROM), mechanical axis deviation (MAD), muscle strength, and total healthcare costs. Costs were assessed from a societal perspective (direct medical, direct non‐medical, and indirect productivity costs), and both costs and health outcomes were discounted at 3% annually. The EQ‐5D‐5L–based quality‐adjusted life year (QALY) was the primary outcome; clinical and functional measures were secondary. Multivariate regression models were used to compare outcomes between groups, and 1000‐bootstrap simulations were used to estimate incremental cost‐effectiveness ratios (ICERs). ICERs were interpreted against a willingness‐to‐pay threshold of one to three times China's 2024 gross domestic product per capita (CNY 95,749–287,247 per QALY). Robustness was assessed with inverse‐probability‐of‐treatment‐weighting (IPTW) and age‐stratified (45–54 vs. 55–65 years) sensitivity analyses. Results: Clinical outcomes at final follow‐up did not differ significantly between OWHTO and TKA groups. OWHTO was associated with a lower cumulative cost (mean CNY 121,784) than TKA (CNY 160,075; p < 0.001). In cost‐effectiveness analyses, OWHTO was associated with better outcomes in WOMAC pain, mechanical alignment (MAD), ROM, and dynamic strength at a lower cost than TKA. Quality‐adjusted life year outcomes (EQ‐5D‐5L utility) slightly favored TKA (71.9% of bootstrap samples), yielding an ICER of CNY 5,441,410.25 per QALY for TKA relative to OWHTO, approximately 19 times the upper willingness‐to‐pay threshold (3× GDP per capita, CNY 287,247 per QALY), indicating that the marginal utility gain with TKA was not cost‐effective. The reoperation/revision rate did not differ between groups (OWHTO 0.95% [3/316] vs. TKA 0.59% [3/509]; p = 0.687), and findings were consistent in IPTW‐weighted and age‐stratified sensitivity analyses. Other ICERs were 146,719.91 CNY (WOMAC function), 53,934.07 CNY (WOMAC stiffness), 115,812.43 CNY (isometric strength), and 167,518.20 CNY (sit‐to‐stand power). Results were robust to sensitivity analyses. Conclusion: Over more than 10 years of follow‐up, OWHTO provided outcomes equivalent to TKA while substantially reducing costs. These findings support OWHTO as a cost‐effective option for selected middle‐aged patients with varus knee osteoarthritis. Level of Evidence: Level III, retrospective cohort study.
- Open Access
- 21 July 2026
- Published by JMIR Publications Inc. in JMIR mHealth and uHealth
- Vol. 14, e93050
The Efficiency and Cost-Effectiveness of Wearable Sensors in a Digital Physiotherapeutic Total Hip Arthroplasty–Specific Training System for Patients After Total Hip Arthroplasty: Randomized Controlled Trial
Background: With total hip arthroplasty (THA) volumes rising worldwide, scalable home rehabilitation strategies are needed. Home-based digital physiotherapy can improve recovery after THA, and adding wearable motion sensor feedback may further enhance exercise performance and adherence. However, the impact of sensor-augmented digital rehabilitation on patient outcomes and cost-effectiveness remains unclear. Objective: This study aimed to evaluate the clinical effectiveness (including adherence) and cost-effectiveness of adding wearable sensor feedback to a home-based digital THA rehabilitation program compared with the same digital program without sensors. Methods: We conducted a single-center randomized controlled trial in Shanghai from June 2023 to June 2024. A total of 240 patients who had undergone primary THA were randomized (1:1) to a 12-week home exercise program delivered via a mobile app either with wearable motion sensors for real-time feedback (intervention) or without sensors (control). Both groups received identical exercise content and weekly teleconsultations. Outcomes were assessed at 6, 12, and 24 weeks by blinded evaluators. The primary outcome was the Hip Disability and Osteoarthritis Outcome Score (HOOS) at 24 weeks. Secondary outcomes included HOOS subscales, timed up-and-go (TUG), Berg Balance Scale, 36-item Short Form Health Survey (SF-36) physical and mental scores, Hospital Anxiety and Depression Scale (HADS) anxiety/depression, patient satisfaction, adherence metrics, and total 24-week costs. Intention-to-treat analyses were used. Mixed effects models and χ ² tests were used for group comparisons. Cost-effectiveness was evaluated from a societal perspective. Results: The sensor-based rehabilitation group showed significantly greater improvement in the primary outcome (HOOS overall) than the control group at 24 weeks ( P =.01). Early postoperative gains were larger: At 6 weeks, 4 of the 5 HOOS subscales, TUG time, and all patient-reported outcomes remained significant after Bonferroni correction for 47 secondary comparisons (adjusted P <.001). By 24 weeks, hip-specific functional differences had narrowed, but SF-36 physical and mental scores (both P <.001) and HADS anxiety and depression scores (both P <.001) remained significant after correction. Total 24-week costs were similar between the groups (¥87,967 vs ¥94,396 [US $12,879.80 vs $13,821.10] per patient; P =.32). The sensor intervention was associated with numerically lower costs on average (¥6428.98 [US $941.31] less per patient), yielding negative incremental cost-effectiveness ratios, though the cost difference was not statistically significant. Adherence was high in both groups but higher with sensors: The intervention group completed more exercise sessions ( P =.002) and showed greater participation in weekly assessments and follow-up calls (both P <.001). Adverse events were uncommon in both groups (5.8% vs 7.5%) and mostly minor, with no serious events reported. Conclusions: Augmenting home-based digital rehabilitation with wearable sensor feedback led to statistically significant improvements in the primary hip function outcome and in patient-reported quality of life and psychological outcomes that persisted after Bonferroni correction through 24 weeks. Several early hip-specific secondary outcome differences did not survive correction for multiple comparisons. The between-group HOOS differences were below the established minimal clinically important difference. Exercise adherence was significantly higher in the sensor group. These benefits were achieved with no increase in cost, suggesting the sensor-enhanced program is a safe and feasible approach to THA rehabilitation that enhances adherence and accelerates early recovery.
- 21 July 2026
- Published by JMIR Publications Inc. in JMIR mHealth and uHealth
- Vol. 14, e93050
Open AccessThe Efficiency and Cost-Effectiveness of Wearable Sensors in a Digital Physiotherapeutic Total Hip Arthroplasty–Specific Training System for Patients After Total Hip Arthroplasty: Randomized Controlled Trial
Background: With total hip arthroplasty (THA) volumes rising worldwide, scalable home rehabilitation strategies are needed. Home-based digital physiotherapy can improve recovery after THA, and adding wearable motion sensor feedback may further enhance exercise performance and adherence. However, the impact of sensor-augmented digital rehabilitation on patient outcomes and cost-effectiveness remains unclear. Objective: This study aimed to evaluate the clinical effectiveness (including adherence) and cost-effectiveness of adding wearable sensor feedback to a home-based digital THA rehabilitation program compared with the same digital program without sensors. Methods: We conducted a single-center randomized controlled trial in Shanghai from June 2023 to June 2024. A total of 240 patients who had undergone primary THA were randomized (1:1) to a 12-week home exercise program delivered via a mobile app either with wearable motion sensors for real-time feedback (intervention) or without sensors (control). Both groups received identical exercise content and weekly teleconsultations. Outcomes were assessed at 6, 12, and 24 weeks by blinded evaluators. The primary outcome was the Hip Disability and Osteoarthritis Outcome Score (HOOS) at 24 weeks. Secondary outcomes included HOOS subscales, timed up-and-go (TUG), Berg Balance Scale, 36-item Short Form Health Survey (SF-36) physical and mental scores, Hospital Anxiety and Depression Scale (HADS) anxiety/depression, patient satisfaction, adherence metrics, and total 24-week costs. Intention-to-treat analyses were used. Mixed effects models and χ ² tests were used for group comparisons. Cost-effectiveness was evaluated from a societal perspective. Results: The sensor-based rehabilitation group showed significantly greater improvement in the primary outcome (HOOS overall) than the control group at 24 weeks ( P =.01). Early postoperative gains were larger: At 6 weeks, 4 of the 5 HOOS subscales, TUG time, and all patient-reported outcomes remained significant after Bonferroni correction for 47 secondary comparisons (adjusted P <.001). By 24 weeks, hip-specific functional differences had narrowed, but SF-36 physical and mental scores (both P <.001) and HADS anxiety and depression scores (both P <.001) remained significant after correction. Total 24-week costs were similar between the groups (¥87,967 vs ¥94,396 [US $12,879.80 vs $13,821.10] per patient; P =.32). The sensor intervention was associated with numerically lower costs on average (¥6428.98 [US $941.31] less per patient), yielding negative incremental cost-effectiveness ratios, though the cost difference was not statistically significant. Adherence was high in both groups but higher with sensors: The intervention group completed more exercise sessions ( P =.002) and showed greater participation in weekly assessments and follow-up calls (both P <.001). Adverse events were uncommon in both groups (5.8% vs 7.5%) and mostly minor, with no serious events reported. Conclusions: Augmenting home-based digital rehabilitation with wearable sensor feedback led to statistically significant improvements in the primary hip function outcome and in patient-reported quality of life and psychological outcomes that persisted after Bonferroni correction through 24 weeks. Several early hip-specific secondary outcome differences did not survive correction for multiple comparisons. The between-group HOOS differences were below the established minimal clinically important difference. Exercise adherence was significantly higher in the sensor group. These benefits were achieved with no increase in cost, suggesting the sensor-enhanced program is a safe and feasible approach to THA rehabilitation that enhances adherence and accelerates early recovery.