James Griffin
Current Organizations / Institutes
The organizations/institutes from the scholar's latest article
Previous Organizations / Institutes
The organizations / institutes from the scholar's other articles in the past ten years
James Griffin has a total of 357 co-authors. Here are the top co-authors by number of shared publications:
- Nick Parsons
Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK
8 shared publications - Stavros Petrou
University of Oxford
8 shared publications - Damian Griffin
Warwick Medical School, University of Warwick, Coventry, UK
7 shared publications - Martin Underwood
University of Warwick
7 shared publications - Andrew Metcalfe
Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK
6 shared publications - Peter David Henry Wall
The Royal Orthopaedic Hospital NHS Foundation Trust, Birmingham, UK
6 shared publications
Latest Publications
- 1 July 2025
- Published by British Editorial Society of Bone & Joint Surgery in The Bone & Joint Journal
- Vol. 107-B (7) , 716-722
Metal-on-metal hip resurfacing compared with contemporary total hip arthroplasty
Aims: Our aim was to estimate the survival of hip resurfacing arthroplasty (HRA) currently available for implantation (males only, head size > 48 mm, MatOrtho Adept or Smith & Nephew Birmingham Hip Resurfacing (BHR)), performed by all surgeons, compared with total hip arthroplasty (THA) using contemporary bearings and fixation.Methods: We performed a retrospective analysis of the National Joint Registry. We included all males who had undergone BHR or Adept with a head size greater than 48 mm. Propensity score matching was used to produce two comparable groups of patients for HRA or contemporary THA. We matched in a 3:1 ratio (THA:HRA) using sex, American Society of Anesthesiologists grade, BMI group, age at primary procedure, surgeon volume, diagnosis, and surgeon grade as covariates. The primary analysis was survival at 18 years. Time to revision was assessed using Kaplan-Meier curves. Cox’s proportional hazard models were used to investigate between-group differences with adjustment for matching factors.Results: A total of 9,574 HRAs were available for analysis. After matching, the HRA and THA groups were well balanced in terms of covariates. Survival at 18 years was 92.7% (95% CI 91.9 to 93.3) in the HRA group and 94.2% (93.5 to 94.8) in the THA group. Despite these relatively similar estimates, the adjusted hazard ratio (HR) was 1.22 (95% CI 1.09 to 1.36; p < 0.001) for all-cause revision over the entire study period, indicating that the HRA group experienced higher probability of revision than the THA group.Conclusion: Survival of HRA was 92.7% at 18 years. However, the HR for all-cause revision for HRA was higher compared with THA.Cite this article: Bone Joint J 2025;107-B(7):716–722.
- 1 July 2025
- Published by British Editorial Society of Bone & Joint Surgery in The Bone & Joint Journal
- Vol. 107-B (7) , 716-722
Metal-on-metal hip resurfacing compared with contemporary total hip arthroplasty
Aims: Our aim was to estimate the survival of hip resurfacing arthroplasty (HRA) currently available for implantation (males only, head size > 48 mm, MatOrtho Adept or Smith & Nephew Birmingham Hip Resurfacing (BHR)), performed by all surgeons, compared with total hip arthroplasty (THA) using contemporary bearings and fixation.Methods: We performed a retrospective analysis of the National Joint Registry. We included all males who had undergone BHR or Adept with a head size greater than 48 mm. Propensity score matching was used to produce two comparable groups of patients for HRA or contemporary THA. We matched in a 3:1 ratio (THA:HRA) using sex, American Society of Anesthesiologists grade, BMI group, age at primary procedure, surgeon volume, diagnosis, and surgeon grade as covariates. The primary analysis was survival at 18 years. Time to revision was assessed using Kaplan-Meier curves. Cox’s proportional hazard models were used to investigate between-group differences with adjustment for matching factors.Results: A total of 9,574 HRAs were available for analysis. After matching, the HRA and THA groups were well balanced in terms of covariates. Survival at 18 years was 92.7% (95% CI 91.9 to 93.3) in the HRA group and 94.2% (93.5 to 94.8) in the THA group. Despite these relatively similar estimates, the adjusted hazard ratio (HR) was 1.22 (95% CI 1.09 to 1.36; p < 0.001) for all-cause revision over the entire study period, indicating that the HRA group experienced higher probability of revision than the THA group.Conclusion: Survival of HRA was 92.7% at 18 years. However, the HR for all-cause revision for HRA was higher compared with THA.Cite this article: Bone Joint J 2025;107-B(7):716–722.
- 19 June 2025
- Published by Wolters Kluwer Health in Journal of Bone and Joint Surgery
- Vol. 107 (15) , 1659-1669
Risk of Revision and Patient-Reported Outcomes Following Primary UKR Performed Using Computer Navigation or Patient-Specific Instrumentation
Background: Computer navigation and patient-specific instrumentation in unicompartmental knee replacement (UKR) improve the precision of implant positioning, but there is limited information regarding their impact on implant survival and patient-reported outcomes. We aimed to compare postoperative implant survival, Oxford Knee Score (OKS) values, health-related quality of life (measured using the EuroQol-5 Dimension 3-level version [EQ-5D-3L]), and intraoperative complications between UKRs performed using computer navigation or patient-specific instrumentation versus conventional instrumentation. Methods: Using National Joint Registry data, an observational study of patients who underwent primary UKR for osteoarthritis between 2003 and 2020 was performed. The primary analyses focused on all-cause revision, and the secondary analyses focused on differences in the OKS and EQ-5D-3L at 6 to 12 months postoperatively. To account for several covariates, weights based on propensity scores were generated. Cox proportional hazards models and generalized linear models were used to assess for differences in revision risk, and OKS and EQ-5D-3L change scores, respectively, between patient groups. Sensitivity analyses accounting for body mass index were performed. Effective sample sizes (ESSs) were computed, representing the statistical power comparable with that of an unweighted sample. Results: Compared with conventional instrumentation, the hazard ratio (HR) for all-cause revision was 1.126 (95% confidence interval [CI], 0.909 to 1.395; p = 0.277; ESS, 4,273) with computer navigation and 0.805 (95% CI, 0.442 to 1.467; p = 0.478; ESS, 1,199) with patient-specific instrumentation. No difference was found in the change in OKS between the groups (−1.287; 95% CI, −2.851 to 0.278; p = 0.107; ESS, 470), although improvement in the EQ-5D-3L scores was relatively lower for computer-navigated UKR compared with conventional instrumentation (−0.049, 95% CI, −0.093 to −0.005; p = 0.028; ESS, 455). However, sensitivity analyses demonstrated that computer navigation was associated with an increased risk of all-cause revision (HR, 1.446; 95% CI, 1.102 to 1.898; p = 0.008; ESS, 3,011) and relatively smaller improvements in the OKS (−2.845; 95% CI, −5.006 to −0.684; p = 0.010; ESS, 272) and EQ-5D-3L scores (−0.087; 95% CI, −0.145 to −0.030; p = 0.003; ESS, 286). There were no differences in intraoperative complications (p = 0.073). Conclusions: This study found no clinically meaningful differences in patient-reported outcomes following computer-navigated UKR. Although likely underpowered, the primary analyses showed no difference in implant survival. While a sensitivity analysis suggested that computer navigation could worsen implant survival, this analysis had a smaller sample size. These findings highlight potential signals that warrant further investigation. Level of Evidence: Therapeutic Level III . See Instructions for Authors for a complete description of levels of evidence.
- 19 June 2025
- Published by Wolters Kluwer Health in Journal of Bone and Joint Surgery
- Vol. 107 (15) , 1659-1669
Risk of Revision and Patient-Reported Outcomes Following Primary UKR Performed Using Computer Navigation or Patient-Specific Instrumentation
Background: Computer navigation and patient-specific instrumentation in unicompartmental knee replacement (UKR) improve the precision of implant positioning, but there is limited information regarding their impact on implant survival and patient-reported outcomes. We aimed to compare postoperative implant survival, Oxford Knee Score (OKS) values, health-related quality of life (measured using the EuroQol-5 Dimension 3-level version [EQ-5D-3L]), and intraoperative complications between UKRs performed using computer navigation or patient-specific instrumentation versus conventional instrumentation. Methods: Using National Joint Registry data, an observational study of patients who underwent primary UKR for osteoarthritis between 2003 and 2020 was performed. The primary analyses focused on all-cause revision, and the secondary analyses focused on differences in the OKS and EQ-5D-3L at 6 to 12 months postoperatively. To account for several covariates, weights based on propensity scores were generated. Cox proportional hazards models and generalized linear models were used to assess for differences in revision risk, and OKS and EQ-5D-3L change scores, respectively, between patient groups. Sensitivity analyses accounting for body mass index were performed. Effective sample sizes (ESSs) were computed, representing the statistical power comparable with that of an unweighted sample. Results: Compared with conventional instrumentation, the hazard ratio (HR) for all-cause revision was 1.126 (95% confidence interval [CI], 0.909 to 1.395; p = 0.277; ESS, 4,273) with computer navigation and 0.805 (95% CI, 0.442 to 1.467; p = 0.478; ESS, 1,199) with patient-specific instrumentation. No difference was found in the change in OKS between the groups (−1.287; 95% CI, −2.851 to 0.278; p = 0.107; ESS, 470), although improvement in the EQ-5D-3L scores was relatively lower for computer-navigated UKR compared with conventional instrumentation (−0.049, 95% CI, −0.093 to −0.005; p = 0.028; ESS, 455). However, sensitivity analyses demonstrated that computer navigation was associated with an increased risk of all-cause revision (HR, 1.446; 95% CI, 1.102 to 1.898; p = 0.008; ESS, 3,011) and relatively smaller improvements in the OKS (−2.845; 95% CI, −5.006 to −0.684; p = 0.010; ESS, 272) and EQ-5D-3L scores (−0.087; 95% CI, −0.145 to −0.030; p = 0.003; ESS, 286). There were no differences in intraoperative complications (p = 0.073). Conclusions: This study found no clinically meaningful differences in patient-reported outcomes following computer-navigated UKR. Although likely underpowered, the primary analyses showed no difference in implant survival. While a sensitivity analysis suggested that computer navigation could worsen implant survival, this analysis had a smaller sample size. These findings highlight potential signals that warrant further investigation. Level of Evidence: Therapeutic Level III . See Instructions for Authors for a complete description of levels of evidence.
- 19 February 2025
- Published by Wolters Kluwer Health in Journal of Bone and Joint Surgery
- Vol. 107 (8) , 829-839
The Effects of Computer Navigation and Patient-Specific Instrumentation on Risk of Revision, PROMs, and Mortality Following Primary TKR
Background: Computer navigation and patient-specific instrumentation have been in use over the past 2 decades for total knee replacement (TKR). However, their effects on implant survival and patient-reported outcomes remain under debate. We aimed to investigate their influence on implant survival, outcomes of the Oxford Knee Score (OKS) and health-related quality of life (EQ-5D-3L), intraoperative complications, and postoperative mortality compared with conventional instrumentation, across a real-world population. Methods: This observational study used National Joint Registry (NJR) data and included adult patients who underwent primary TKR for osteoarthritis between April 1, 2003, and December 31, 2020. The primary analysis evaluated revision for all causes, and secondary analyses evaluated differences in the OKS and EQ-5D-3L at 6 months postoperatively, and mortality within 1 year postoperatively. Weights based on propensity scores were generated, accounting for several covariates. A Cox proportional hazards model was used to assess revision and mortality outcomes. Generalized linear models were used to evaluate differences in the OKS and EQ-5D-3L. Effective sample sizes were computed and represent the statistical power comparable with an unweighted sample. Results: Compared to conventional instrumentation, the hazard ratios (HRs) for all-cause revision following TKR performed using computer navigation and patient-specific instrumentation were 0.937 (95% confidence interval [CI], 0.860 to 1.021; p = 0.136; effective sample size [ESS] = 91,607) and 0.960 (95% CI, 0.735 to 1.252; p = 0.761; ESS = 13,297), respectively. No differences were observed in the OKS and EQ-5D-3L between conventional and computer-navigated TKR (OKS, −0.134 [95% CI, −0.331 to 0.063]; p = 0.183; ESS = 29,135; and EQ-5D-3L, 0.000 [95% CI, −0.005 to 0.005]; p = 0.929; ESS = 28,396) and between conventional TKR and TKR with patient-specific instrumentation (OKS, 0.363 [95% CI, −0.104 to 0.830]; p = 0.127; ESS = 4,412; and EQ-5D-3L, 0.004 [95% CI, −0.009 to 0.018]; p = 0.511; ESS = 4,285). Mortality within 1 year postoperatively was similar between conventional instrumentation and either computer navigation or patient-specific instrumentation (HR, 1.020 [95% CI, 0.989 to 1.052]; p = 0.212; ESS = 110,125). Conclusions: On the basis of this large registry study, we conclude that computer navigation and patient-specific instrumentation have no statistically or clinically meaningful effect on the risk of revision, patient-reported outcomes, or mortality following primary TKR. Level of Evidence: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.
- 19 February 2025
- Published by Wolters Kluwer Health in Journal of Bone and Joint Surgery
- Vol. 107 (8) , 829-839
The Effects of Computer Navigation and Patient-Specific Instrumentation on Risk of Revision, PROMs, and Mortality Following Primary TKR
Background: Computer navigation and patient-specific instrumentation have been in use over the past 2 decades for total knee replacement (TKR). However, their effects on implant survival and patient-reported outcomes remain under debate. We aimed to investigate their influence on implant survival, outcomes of the Oxford Knee Score (OKS) and health-related quality of life (EQ-5D-3L), intraoperative complications, and postoperative mortality compared with conventional instrumentation, across a real-world population. Methods: This observational study used National Joint Registry (NJR) data and included adult patients who underwent primary TKR for osteoarthritis between April 1, 2003, and December 31, 2020. The primary analysis evaluated revision for all causes, and secondary analyses evaluated differences in the OKS and EQ-5D-3L at 6 months postoperatively, and mortality within 1 year postoperatively. Weights based on propensity scores were generated, accounting for several covariates. A Cox proportional hazards model was used to assess revision and mortality outcomes. Generalized linear models were used to evaluate differences in the OKS and EQ-5D-3L. Effective sample sizes were computed and represent the statistical power comparable with an unweighted sample. Results: Compared to conventional instrumentation, the hazard ratios (HRs) for all-cause revision following TKR performed using computer navigation and patient-specific instrumentation were 0.937 (95% confidence interval [CI], 0.860 to 1.021; p = 0.136; effective sample size [ESS] = 91,607) and 0.960 (95% CI, 0.735 to 1.252; p = 0.761; ESS = 13,297), respectively. No differences were observed in the OKS and EQ-5D-3L between conventional and computer-navigated TKR (OKS, −0.134 [95% CI, −0.331 to 0.063]; p = 0.183; ESS = 29,135; and EQ-5D-3L, 0.000 [95% CI, −0.005 to 0.005]; p = 0.929; ESS = 28,396) and between conventional TKR and TKR with patient-specific instrumentation (OKS, 0.363 [95% CI, −0.104 to 0.830]; p = 0.127; ESS = 4,412; and EQ-5D-3L, 0.004 [95% CI, −0.009 to 0.018]; p = 0.511; ESS = 4,285). Mortality within 1 year postoperatively was similar between conventional instrumentation and either computer navigation or patient-specific instrumentation (HR, 1.020 [95% CI, 0.989 to 1.052]; p = 0.212; ESS = 110,125). Conclusions: On the basis of this large registry study, we conclude that computer navigation and patient-specific instrumentation have no statistically or clinically meaningful effect on the risk of revision, patient-reported outcomes, or mortality following primary TKR. Level of Evidence: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.
- Open Access
Recurrent patellar dislocation: personalised therapy or operative treatment? The REPPORT randomised trial protocol
Introduction Recurrent patellar dislocation is a debilitating musculoskeletal condition, affecting mainly adolescents and adults under the age of 30. It can persist for many decades, causing pain and cartilage and soft-tissue damage, potentially leading to osteoarthritis. Recurrent patellar dislocation can be managed with physiotherapy or surgery. However, it is not known which treatment is most effective. Methods and analysis Recurrent Patellar Dislocation: Personalised Therapy or Operative Treatment (REPPORT) is a pragmatic, multicentre, two-arm, superiority, randomised controlled trial. It will compare the clinical and cost-effectiveness of an initial management strategy of personalised, phased and progressive rehabilitation, termed personalised knee therapy versus surgery for recurrent patellar dislocation. The trial’s target sample size is 276 participants who will be recruited from approximately 20 sites across the UK. Participants will be randomly allocated to the two treatment groups via a central computer-based minimisation system. Treatment allocation will be in a 1:1 ratio, stratified by age, presence of patella alta and recruitment site. The primary outcome is participant-reported function using the Knee injury and Osteoarthritis Outcome 4-domain score at 18 months post randomisation. Health economic evaluation will be conducted from a healthcare system and personal social services perspective. Secondary outcome data including patellar instability, health utility, work/education status, satisfaction with social roles and treatment, health resource use and adverse events will be collected at 6, 12, 18 and 24 months. Analysis will be on an intention-to-treat basis and reported in-line with the Consolidated Standards of Reporting Trials statement. Ethics and dissemination The trial was approved by the East Midlands—Nottingham 2 Research Ethics Committee on 30 March 2023. Results will be disseminated via peer-reviewed publications, presentations at national and international conferences, in lay summaries, and using the REPPORT website and social media channels. Trial registration number ISRCTN17972668.
Open AccessRecurrent patellar dislocation: personalised therapy or operative treatment? The REPPORT randomised trial protocol
Introduction Recurrent patellar dislocation is a debilitating musculoskeletal condition, affecting mainly adolescents and adults under the age of 30. It can persist for many decades, causing pain and cartilage and soft-tissue damage, potentially leading to osteoarthritis. Recurrent patellar dislocation can be managed with physiotherapy or surgery. However, it is not known which treatment is most effective. Methods and analysis Recurrent Patellar Dislocation: Personalised Therapy or Operative Treatment (REPPORT) is a pragmatic, multicentre, two-arm, superiority, randomised controlled trial. It will compare the clinical and cost-effectiveness of an initial management strategy of personalised, phased and progressive rehabilitation, termed personalised knee therapy versus surgery for recurrent patellar dislocation. The trial’s target sample size is 276 participants who will be recruited from approximately 20 sites across the UK. Participants will be randomly allocated to the two treatment groups via a central computer-based minimisation system. Treatment allocation will be in a 1:1 ratio, stratified by age, presence of patella alta and recruitment site. The primary outcome is participant-reported function using the Knee injury and Osteoarthritis Outcome 4-domain score at 18 months post randomisation. Health economic evaluation will be conducted from a healthcare system and personal social services perspective. Secondary outcome data including patellar instability, health utility, work/education status, satisfaction with social roles and treatment, health resource use and adverse events will be collected at 6, 12, 18 and 24 months. Analysis will be on an intention-to-treat basis and reported in-line with the Consolidated Standards of Reporting Trials statement. Ethics and dissemination The trial was approved by the East Midlands—Nottingham 2 Research Ethics Committee on 30 March 2023. Results will be disseminated via peer-reviewed publications, presentations at national and international conferences, in lay summaries, and using the REPPORT website and social media channels. Trial registration number ISRCTN17972668.
- Open Access
UK robotic arthroplasty clinical and cost effectiveness randomised controlled trial for hips (RACER-Hip): a study protocol
Introduction The number of robotic-assisted hip replacement procedures has expanded globally with the intended aim of improving outcomes. Intraoperative robotic-arm systems add additional costs to total hip replacement (THR) surgery but may improve surgical precision and could contribute to diminished pain and improved function. Additionally, these systems may reduce the need for expensive revision surgery. Surgery with conventional instruments may be just as successful, quick and affordable. There is timely demand for a robust evaluation of this technology. Methods and analysis The Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial for Hips (RACER-Hip) is a multicentre (minimum of six UK sites), participant–assessor blinded, randomised controlled trial. 378 participants with hip osteoarthritis requiring THR will be randomised (1:1) to receive robotic-assisted THR, or THR using conventional surgical instruments. The primary outcome is the Forgotten Joint Score at 12 months post-randomisation; a patient-reported outcome measure assessing participants’ awareness of their joint when undertaking daily activities. Secondary outcomes will be collected post-operatively (pain, blood loss and opioid usage) and at 3, 6, 12, 24 months, then 5 and 10 years postrandomisation (including function, pain, health-related quality of life, reoperations and satisfaction). Allocation concealment will be accomplished using a computer-based randomisation procedure on the day of surgery. Blinding methods include the use of sham incisions for marker clusters and blinded operation notes. The primary analysis will adhere to the intention-to-treat principle. Results will adhere to Consolidated Standards of Reporting Trials statements. Ethics and dissemination The trial was approved by an ethics committee (Solihull Research Ethics Committee, 30 June 2021, IRAS: 295831). Participants will provide informed consent before agreeing to participate. Results will be disseminated using peer-reviewed journal publications, presentations at international conferences and through the use of social media. We will develop plans to disseminate to patients and public with our patient partners. Trial registration number ISRCTN13374625.
Open AccessUK robotic arthroplasty clinical and cost effectiveness randomised controlled trial for hips (RACER-Hip): a study protocol
Introduction The number of robotic-assisted hip replacement procedures has expanded globally with the intended aim of improving outcomes. Intraoperative robotic-arm systems add additional costs to total hip replacement (THR) surgery but may improve surgical precision and could contribute to diminished pain and improved function. Additionally, these systems may reduce the need for expensive revision surgery. Surgery with conventional instruments may be just as successful, quick and affordable. There is timely demand for a robust evaluation of this technology. Methods and analysis The Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial for Hips (RACER-Hip) is a multicentre (minimum of six UK sites), participant–assessor blinded, randomised controlled trial. 378 participants with hip osteoarthritis requiring THR will be randomised (1:1) to receive robotic-assisted THR, or THR using conventional surgical instruments. The primary outcome is the Forgotten Joint Score at 12 months post-randomisation; a patient-reported outcome measure assessing participants’ awareness of their joint when undertaking daily activities. Secondary outcomes will be collected post-operatively (pain, blood loss and opioid usage) and at 3, 6, 12, 24 months, then 5 and 10 years postrandomisation (including function, pain, health-related quality of life, reoperations and satisfaction). Allocation concealment will be accomplished using a computer-based randomisation procedure on the day of surgery. Blinding methods include the use of sham incisions for marker clusters and blinded operation notes. The primary analysis will adhere to the intention-to-treat principle. Results will adhere to Consolidated Standards of Reporting Trials statements. Ethics and dissemination The trial was approved by an ethics committee (Solihull Research Ethics Committee, 30 June 2021, IRAS: 295831). Participants will provide informed consent before agreeing to participate. Results will be disseminated using peer-reviewed journal publications, presentations at international conferences and through the use of social media. We will develop plans to disseminate to patients and public with our patient partners. Trial registration number ISRCTN13374625.
- Open Access
- 21 August 2023
- Published by British Editorial Society of Bone & Joint Surgery in Bone & Joint Open
- Vol. 4 (8) , 602-611
Hip fracture surgery performed by cadaveric simulation-trained versus standard-trained orthopaedic trainees: a preliminary multicentre randomized controlled trial
Aims: To evaluate if, for orthopaedic trainees, additional cadaveric simulation training or standard training alone yields superior radiological and clinical outcomes in patients undergoing dynamic hip screw (DHS) fixation or hemiarthroplasty for hip fracture.Methods: This was a preliminary, pragmatic, multicentre, parallel group randomized controlled trial in nine secondary and tertiary NHS hospitals in England. Researchers were blinded to group allocation. Overall, 40 trainees in the West Midlands were eligible: 33 agreed to take part and were randomized, five withdrew after randomization, 13 were allocated cadaveric training, and 15 were allocated standard training. The intervention was an additional two-day cadaveric simulation course. The control group received standard on-the-job training. Primary outcome was implant position on the postoperative radiograph: tip-apex distance (mm) (DHS) and leg length discrepancy (mm) (hemiarthroplasty). Secondary clinical outcomes were procedure time, length of hospital stay, acute postoperative complication rate, and 12-month mortality. Procedure-specific secondary outcomes were intraoperative radiation dose (for DHS) and postoperative blood transfusion requirement (hemiarthroplasty).Results: Eight female (29%) and 20 male trainees (71%), mean age 29.4 years, performed 317 DHS operations and 243 hemiarthroplasties during ten months of follow-up. Primary analysis was a random effect model with surgeon-level fixed effects of patient condition, patient age, and surgeon experience, with a random intercept for surgeon. Under the intention-to-treat principle, for hemiarthroplasty there was better implant position in favour of cadaveric training, measured by leg length discrepancy ≤ 10 mm (odds ratio (OR) 4.08 (95% confidence interval (CI) 1.17 to 14.22); p = 0.027). There were significantly fewer postoperative blood transfusions required in patients undergoing hemiarthroplasty by cadaveric-trained compared to standard-trained surgeons (OR 6.00 (95% CI 1.83 to 19.69); p = 0.003). For DHS, there was no significant between-group difference in implant position as measured by tip-apex distance ≤ 25 mm (OR 6.47 (95% CI 0.97 to 43.05); p = 0.053). No between-group differences were observed for any secondary clinical outcomes.Conclusion: Trainees randomized to additional cadaveric training performed hip fracture fixation with better implant positioning and fewer postoperative blood transfusions in hemiarthroplasty. This effect, which was previously unknown, may be a consequence of the intervention. Further study is required.Cite this article: Bone Jt Open 2023;4(8):602–611.
- 21 August 2023
- Published by British Editorial Society of Bone & Joint Surgery in Bone & Joint Open
- Vol. 4 (8) , 602-611
Open AccessHip fracture surgery performed by cadaveric simulation-trained versus standard-trained orthopaedic trainees: a preliminary multicentre randomized controlled trial
Aims: To evaluate if, for orthopaedic trainees, additional cadaveric simulation training or standard training alone yields superior radiological and clinical outcomes in patients undergoing dynamic hip screw (DHS) fixation or hemiarthroplasty for hip fracture.Methods: This was a preliminary, pragmatic, multicentre, parallel group randomized controlled trial in nine secondary and tertiary NHS hospitals in England. Researchers were blinded to group allocation. Overall, 40 trainees in the West Midlands were eligible: 33 agreed to take part and were randomized, five withdrew after randomization, 13 were allocated cadaveric training, and 15 were allocated standard training. The intervention was an additional two-day cadaveric simulation course. The control group received standard on-the-job training. Primary outcome was implant position on the postoperative radiograph: tip-apex distance (mm) (DHS) and leg length discrepancy (mm) (hemiarthroplasty). Secondary clinical outcomes were procedure time, length of hospital stay, acute postoperative complication rate, and 12-month mortality. Procedure-specific secondary outcomes were intraoperative radiation dose (for DHS) and postoperative blood transfusion requirement (hemiarthroplasty).Results: Eight female (29%) and 20 male trainees (71%), mean age 29.4 years, performed 317 DHS operations and 243 hemiarthroplasties during ten months of follow-up. Primary analysis was a random effect model with surgeon-level fixed effects of patient condition, patient age, and surgeon experience, with a random intercept for surgeon. Under the intention-to-treat principle, for hemiarthroplasty there was better implant position in favour of cadaveric training, measured by leg length discrepancy ≤ 10 mm (odds ratio (OR) 4.08 (95% confidence interval (CI) 1.17 to 14.22); p = 0.027). There were significantly fewer postoperative blood transfusions required in patients undergoing hemiarthroplasty by cadaveric-trained compared to standard-trained surgeons (OR 6.00 (95% CI 1.83 to 19.69); p = 0.003). For DHS, there was no significant between-group difference in implant position as measured by tip-apex distance ≤ 25 mm (OR 6.47 (95% CI 0.97 to 43.05); p = 0.053). No between-group differences were observed for any secondary clinical outcomes.Conclusion: Trainees randomized to additional cadaveric training performed hip fracture fixation with better implant positioning and fewer postoperative blood transfusions in hemiarthroplasty. This effect, which was previously unknown, may be a consequence of the intervention. Further study is required.Cite this article: Bone Jt Open 2023;4(8):602–611.
- Open Access
- 17 August 2023
- Published by British Editorial Society of Bone & Joint Surgery in Bone & Joint Open
- Vol. 4 (8) , 594-601
Ankle fracture internal fixation performed by cadaveric simulation-trained versus standard-trained orthopaedic trainees: a preliminary, multicentre randomized controlled trial
Ankle fracture internal fixation performed by cadaveric simulation-trained versus standard-trained orthopaedic trainees: a preliminary, multicentre randomized controlled trial
- 17 August 2023
- Published by British Editorial Society of Bone & Joint Surgery in Bone & Joint Open
- Vol. 4 (8) , 594-601
Open AccessAnkle fracture internal fixation performed by cadaveric simulation-trained versus standard-trained orthopaedic trainees: a preliminary, multicentre randomized controlled trial
Ankle fracture internal fixation performed by cadaveric simulation-trained versus standard-trained orthopaedic trainees: a preliminary, multicentre randomized controlled trial
- Open Access
Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial (RACER-knee): a study protocol
Introduction Robotic-assisted knee replacement systems have been introduced to healthcare services worldwide in an effort to improve clinical outcomes for people, although high-quality evidence that they are clinically, or cost-effective remains sparse. Robotic-arm systems may improve surgical accuracy and could contribute to reduced pain, improved function and lower overall cost of total knee replacement (TKR) surgery. However, TKR with conventional instruments may be just as effective and may be quicker and cheaper. There is a need for a robust evaluation of this technology, including cost-effectiveness analyses using both within-trial and modelling approaches. This trial will compare robotic-assisted against conventional TKR to provide high-quality evidence on whether robotic-assisted knee replacement is beneficial to patients and cost-effective for healthcare systems. Methods and analysis The Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial-Knee is a multicentre, participant-assessor blinded, randomised controlled trial to evaluate the clinical and cost-effectiveness of robotic-assisted TKR compared with TKR using conventional instruments. A total of 332 participants will be randomised (1:1) to provide 90% power for a 12-point difference in the primary outcome measure; the Forgotten Joint Score at 12 months postrandomisation. Allocation concealment will be achieved using computer-based randomisation performed on the day of surgery and methods for blinding will include sham incisions for marker clusters and blinded operation notes. The primary analysis will adhere to the intention-to-treat principle. Results will be reported in line with the Consolidated Standards of Reporting Trials statement. A parallel study will collect data on the learning effects associated with robotic-arm systems. Ethics and dissemination The trial has been approved by an ethics committee for patient participation (East Midlands—Nottingham 2 Research Ethics Committee, 29 July 2020. NRES number: 20/EM/0159). All results from the study will be disseminated using peer-reviewed publications, presentations at international conferences, lay summaries and social media as appropriate. Trial registration number ISRCTN27624068.
Open AccessRobotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial (RACER-knee): a study protocol
Introduction Robotic-assisted knee replacement systems have been introduced to healthcare services worldwide in an effort to improve clinical outcomes for people, although high-quality evidence that they are clinically, or cost-effective remains sparse. Robotic-arm systems may improve surgical accuracy and could contribute to reduced pain, improved function and lower overall cost of total knee replacement (TKR) surgery. However, TKR with conventional instruments may be just as effective and may be quicker and cheaper. There is a need for a robust evaluation of this technology, including cost-effectiveness analyses using both within-trial and modelling approaches. This trial will compare robotic-assisted against conventional TKR to provide high-quality evidence on whether robotic-assisted knee replacement is beneficial to patients and cost-effective for healthcare systems. Methods and analysis The Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial-Knee is a multicentre, participant-assessor blinded, randomised controlled trial to evaluate the clinical and cost-effectiveness of robotic-assisted TKR compared with TKR using conventional instruments. A total of 332 participants will be randomised (1:1) to provide 90% power for a 12-point difference in the primary outcome measure; the Forgotten Joint Score at 12 months postrandomisation. Allocation concealment will be achieved using computer-based randomisation performed on the day of surgery and methods for blinding will include sham incisions for marker clusters and blinded operation notes. The primary analysis will adhere to the intention-to-treat principle. Results will be reported in line with the Consolidated Standards of Reporting Trials statement. A parallel study will collect data on the learning effects associated with robotic-arm systems. Ethics and dissemination The trial has been approved by an ethics committee for patient participation (East Midlands—Nottingham 2 Research Ethics Committee, 29 July 2020. NRES number: 20/EM/0159). All results from the study will be disseminated using peer-reviewed publications, presentations at international conferences, lay summaries and social media as appropriate. Trial registration number ISRCTN27624068.
- 26 April 2023
- Published by Elsevier in The Journal of Foot and Ankle Surgery
- Vol. 62 (4) , 750-751
Re: Evaluation of Proposed Protocol Changing Statistical Significance From 0.05 to 0.005 in Foot and Ankle Randomized Controlled Trials
- 26 April 2023
- Published by Elsevier in The Journal of Foot and Ankle Surgery
- Vol. 62 (4) , 750-751
Re: Evaluation of Proposed Protocol Changing Statistical Significance From 0.05 to 0.005 in Foot and Ankle Randomized Controlled Trials
- Open Access
- 1 December 2022
- Published by National Institute for Health and Care Research in Health and Social Care Delivery Research
- Vol. 10 (40) , 1-140
Recommended summary plan for emergency care and treatment: ReSPECT a mixed-methods study
Background: Do not attempt cardiopulmonary resuscitation decisions have been widely criticised. The Recommended Summary Plan for Emergency Care and Treatment (ReSPECT) process was developed to facilitate shared decisions between patients and clinicians in relation to emergency treatments, including cardiopulmonary resuscitation. Objective: To explore how, when and why ReSPECT plans are made and what effects the plans have on patient outcomes. Design: A mixed-methods evaluation, comprising (1) a qualitative study of ReSPECT decision-making processes, (2) an interrupted time series examining process and survival outcomes following in-hospital cardiac arrest and (3) a retrospective observational study examining factors associated with ReSPECT recommendations and patient outcomes. Setting: NHS acute hospitals and primary care and community services in England (2017–2020). Participants: Hospital doctors, general practitioners, nurses, patients and families. Data sources: The following sources were used: (1) observations of ReSPECT conversations at six hospitals and conversations with clinicians, patient, families and general practitioners, (2) survey and freedom of information data from hospitals participating in the National Cardiac Arrest Audit and (3) a review of inpatient medical records, ReSPECT forms and NHS Safety Thermometer data. Results: By December 2019, the ReSPECT process was being used in 40 of 186 (22%) acute hospitals. In total, 792 of 3439 (23%) inpatients, usually those identified at risk of deterioration, had a ReSPECT form. Involvement of the patient and/or family was recorded on 513 of 706 (73%) ReSPECT forms reviewed. Clinicians said that lack of time prevented more conversations. Observed conversations focused on resuscitation, but also included other treatments and the patient’s values and preferences. Conversation types included open-ended conversations, with clinicians actively eliciting the patients’ wishes and preferences, a persuasive approach, swaying the conversation towards a decision aligned with medical opinion, and simply informing the patient/relative about a medical decision that had already been made. The frequency of harms reported on the NHS Safety Thermometer was similar among patients with or without a ReSPECT form. Hospital doctors and general practitioners gave different views on the purpose of the ReSPECT process and the type of recommendations they would record. Limitations: The research was undertaken within the first 2 years following the implementation of ReSPECT. Local policies meant that doctors led these conversations. Most patients were seriously ill, which limited opportunities for interviews. Incomplete adoption of the ReSPECT process and problems associated with the NHS Safety Thermometer tool affected the evaluation on clinical outcomes. Conclusions: Patients and families were involved in most ReSPECT conversations. Conversations focused on resuscitation, but also included other emergency treatments. Respect for patient autonomy and duty to protect from harm informed clinicians’ approach to varying degrees, depending on the clinical situation and their views of ReSPECT as a shared decision-making process. The complexity of these conversations and the clinical, emotional and organisational barriers observed suggest that a nuanced and multifaceted approach will be necessary to support good ReSPECT processes. Future work: Further research is needed to understand the advantages and disadvantages to the adoption of a national emergency care and treatment plan system, the most effective national and local implementation approaches, and whether or not shared decision-making approaches in the context of emergency care and treatment plans could further enhance patient and family engagement. Study registration: This study is registered as ISRCTN11112933. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research; Vol. 10, No. 40. See the NIHR Journals Library website for further project information.
- 1 December 2022
- Published by National Institute for Health and Care Research in Health and Social Care Delivery Research
- Vol. 10 (40) , 1-140
Open AccessRecommended summary plan for emergency care and treatment: ReSPECT a mixed-methods study
Background: Do not attempt cardiopulmonary resuscitation decisions have been widely criticised. The Recommended Summary Plan for Emergency Care and Treatment (ReSPECT) process was developed to facilitate shared decisions between patients and clinicians in relation to emergency treatments, including cardiopulmonary resuscitation. Objective: To explore how, when and why ReSPECT plans are made and what effects the plans have on patient outcomes. Design: A mixed-methods evaluation, comprising (1) a qualitative study of ReSPECT decision-making processes, (2) an interrupted time series examining process and survival outcomes following in-hospital cardiac arrest and (3) a retrospective observational study examining factors associated with ReSPECT recommendations and patient outcomes. Setting: NHS acute hospitals and primary care and community services in England (2017–2020). Participants: Hospital doctors, general practitioners, nurses, patients and families. Data sources: The following sources were used: (1) observations of ReSPECT conversations at six hospitals and conversations with clinicians, patient, families and general practitioners, (2) survey and freedom of information data from hospitals participating in the National Cardiac Arrest Audit and (3) a review of inpatient medical records, ReSPECT forms and NHS Safety Thermometer data. Results: By December 2019, the ReSPECT process was being used in 40 of 186 (22%) acute hospitals. In total, 792 of 3439 (23%) inpatients, usually those identified at risk of deterioration, had a ReSPECT form. Involvement of the patient and/or family was recorded on 513 of 706 (73%) ReSPECT forms reviewed. Clinicians said that lack of time prevented more conversations. Observed conversations focused on resuscitation, but also included other treatments and the patient’s values and preferences. Conversation types included open-ended conversations, with clinicians actively eliciting the patients’ wishes and preferences, a persuasive approach, swaying the conversation towards a decision aligned with medical opinion, and simply informing the patient/relative about a medical decision that had already been made. The frequency of harms reported on the NHS Safety Thermometer was similar among patients with or without a ReSPECT form. Hospital doctors and general practitioners gave different views on the purpose of the ReSPECT process and the type of recommendations they would record. Limitations: The research was undertaken within the first 2 years following the implementation of ReSPECT. Local policies meant that doctors led these conversations. Most patients were seriously ill, which limited opportunities for interviews. Incomplete adoption of the ReSPECT process and problems associated with the NHS Safety Thermometer tool affected the evaluation on clinical outcomes. Conclusions: Patients and families were involved in most ReSPECT conversations. Conversations focused on resuscitation, but also included other emergency treatments. Respect for patient autonomy and duty to protect from harm informed clinicians’ approach to varying degrees, depending on the clinical situation and their views of ReSPECT as a shared decision-making process. The complexity of these conversations and the clinical, emotional and organisational barriers observed suggest that a nuanced and multifaceted approach will be necessary to support good ReSPECT processes. Future work: Further research is needed to understand the advantages and disadvantages to the adoption of a national emergency care and treatment plan system, the most effective national and local implementation approaches, and whether or not shared decision-making approaches in the context of emergency care and treatment plans could further enhance patient and family engagement. Study registration: This study is registered as ISRCTN11112933. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research; Vol. 10, No. 40. See the NIHR Journals Library website for further project information.