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Bone & Joint Open
Vol. 3, Issue 4 | Pages 307 - 313
7 Apr 2022
Singh V Bieganowski T Huang S Karia R Davidovitch RI Schwarzkopf R

Aims

The Forgotten Joint Score-12 (FJS-12) is a validated patient-reported outcome measure (PROM) tool designed to assess artificial prosthesis awareness during daily activities following total hip arthroplasty (THA). The patient-acceptable symptom state (PASS) is the minimum cut-off value that corresponds to a patient’s satisfactory state-of-health. Despite the validity and reliability of the FJS-12 having been previously demonstrated, the PASS has yet to be clearly defined. This study aims to define the PASS of the FJS-12 following primary THA.

Methods

We retrospectively reviewed all patients who underwent primary elective THA from 2019 to 2020, and answered both the FJS-12 and the Hip Disability and Osteoarthritis Outcome Score, Joint Replacement (HOOS, JR) questionnaires one-year postoperatively. HOOS, JR score was used as the anchor to estimate the PASS of FJS-12. Two statistical methods were employed: the receiver operating characteristic (ROC) curve point, which maximized the Youden index; and 75th percentile of the cumulative percentage curve of patients who had the HOOS, JR score difference larger than the cut-off value.


The Bone & Joint Journal
Vol. 103-B, Issue 2 | Pages 366 - 372
1 Feb 2021
Sun Z Li J Luo G Wang F Hu Y Fan C

Aims. This study aimed to determine the minimal detectable change (MDC), minimal clinically important difference (MCID), and substantial clinical benefit (SCB) under distribution- and anchor-based methods for the Mayo Elbow Performance Index (MEPI) and range of movement (ROM) after open elbow arthrolysis (OEA). We also assessed the proportion of patients who achieved MCID and SCB; and identified the factors associated with achieving MCID. Methods. A cohort of 265 patients treated by OEA were included. The MEPI and ROM were evaluated at baseline and at two-year follow-up. Distribution-based MDC was calculated with confidence intervals (CIs) reflecting 80% (MDC 80), 90% (MDC 90), and 95% (MDC 95) certainty, and MCID with changes from baseline to follow-up. Anchor-based MCID (anchored to somewhat satisfied) and SCB (very satisfied) were calculated using a five-level Likert satisfaction scale. Multivariate logistic regression of factors affecting MCID achievement was performed. Results. The MDC increased substantially based on selected CIs (MDC 80, MDC 90, and MDC 95), ranging from 5.0 to 7.6 points for the MEPI, and from 8.2° to 12.5° for ROM. The MCID of the MEPI were 8.3 points under distribution-based and 12.2 points under anchor-based methods; distribution- and anchor-based MCID of ROM were 14.1° and 25.0°. The SCB of the MEPI and ROM were 17.3 points and 43.4°, respectively. The proportion of the patients who attained anchor-based MCID for the MEPI and ROM were 74.0% and 94.7%, respectively; furthermore, 64.2% and 86.8% attained SCB. Non-dominant arm (p = 0.022), higher preoperative MEPI rating (p < 0.001), and postoperative visual analogue scale pain score (p < 0.001) were independent predictors of not achieving MCID for the MEPI, while atraumatic causes (p = 0.040) and higher preoperative ROM (p = 0.005) were independent risk factors for ROM. Conclusion. In patients undergoing OEA, the MCID for the increased MEPI is 12.2 points and 25° increased ROM. The SCB is 17.3 points and 43.3°, respectively. Future studies using the MEPI and ROM to assess OEA outcomes should report not only statistical significance but also clinical importance. Cite this article: Bone Joint J 2021;103-B(2):366–372


Bone & Joint Research
Vol. 12, Issue 9 | Pages 512 - 521
1 Sep 2023
Langenberger B Schrednitzki D Halder AM Busse R Pross CM

Aims. A substantial fraction of patients undergoing knee arthroplasty (KA) or hip arthroplasty (HA) do not achieve an improvement as high as the minimal clinically important difference (MCID), i.e. do not achieve a meaningful improvement. Using three patient-reported outcome measures (PROMs), our aim was: 1) to assess machine learning (ML), the simple pre-surgery PROM score, and logistic-regression (LR)-derived performance in their prediction of whether patients undergoing HA or KA achieve an improvement as high or higher than a calculated MCID; and 2) to test whether ML is able to outperform LR or pre-surgery PROM scores in predictive performance. Methods. MCIDs were derived using the change difference method in a sample of 1,843 HA and 1,546 KA patients. An artificial neural network, a gradient boosting machine, least absolute shrinkage and selection operator (LASSO) regression, ridge regression, elastic net, random forest, LR, and pre-surgery PROM scores were applied to predict MCID for the following PROMs: EuroQol five-dimension, five-level questionnaire (EQ-5D-5L), EQ visual analogue scale (EQ-VAS), Hip disability and Osteoarthritis Outcome Score-Physical Function Short-form (HOOS-PS), and Knee injury and Osteoarthritis Outcome Score-Physical Function Short-form (KOOS-PS). Results. Predictive performance of the best models per outcome ranged from 0.71 for HOOS-PS to 0.84 for EQ-VAS (HA sample). ML statistically significantly outperformed LR and pre-surgery PROM scores in two out of six cases. Conclusion. MCIDs can be predicted with reasonable performance. ML was able to outperform traditional methods, although only in a minority of cases. Cite this article: Bone Joint Res 2023;12(9):512–521


Aims. To identify the responsiveness, minimal clinically important difference (MCID), minimal clinical important change (MIC), and patient-acceptable symptom state (PASS) thresholds in the 36-item Short Form Health Survey questionnaire (SF-36) (v2) for each of the eight dimensions and the total score following total knee arthroplasty (TKA). Methods. There were 3,321 patients undergoing primary TKA with preoperative and one-year postoperative SF-36 scores. At one-year patients were asked how satisfied they were and “How much did the knee arthroplasty surgery improve the quality of your life?”, which was graded as: great, moderate, little (n = 277), none (n = 98), or worse. Results. Physical function, role limitations due to physical problems (‘role physical’), bodily pain, and the total score SF-36 scores demonstrated the greatest effect sizes (> 0.9). The MCID for each of SF-36 dimensions ranged from 1.7 for role emotional to 6.4 for bodily pain. The MICs for a cohort of patients ranged from -1.0 for general health to 11.1 for bodily pain. The MICs for an individual patient were marginally greater (one to two points) compared to those for a cohort, and ranging from 0.0 for general and mental health to 13.5 for physical function. The lowest PASS score threshold was associated with physical function (> 34 points) whereas the greatest threshold (> 69 points) was associated with mental health. Conclusion. The SF-36 is a responsive tool, and the estimates for MCID, MIC, and PASS thresholds that can be used to power studies, assess whether there has been a meaningful change in patients’ health-related quality of life, and can be used as a marker of achieving patient satisfaction following TKA. Cite this article: Bone Joint Res 2022;11(7):477–483


Bone & Joint Research
Vol. 11, Issue 9 | Pages 619 - 628
7 Sep 2022
Yapp LZ Scott CEH Howie CR MacDonald DJ Simpson AHRW Clement ND

Aims. The aim of this study was to report the meaningful values of the EuroQol five-dimension three-level questionnaire (EQ-5D-3L) and EuroQol visual analogue scale (EQ-VAS) in patients undergoing primary knee arthroplasty (KA). Methods. This is a retrospective study of patients undergoing primary KA for osteoarthritis in a university teaching hospital (Royal Infirmary of Edinburgh) (1 January 2013 to 31 December 2019). Pre- and postoperative (one-year) data were prospectively collected for 3,181 patients (median age 69.9 years (interquartile range (IQR) 64.2 to 76.1); females, n = 1,745 (54.9%); median BMI 30.1 kg/m. 2. (IQR 26.6 to 34.2)). The reliability of the EQ-5D-3L was measured using Cronbach’s alpha. Responsiveness was determined by calculating the anchor-based minimal clinically important difference (MCID), the minimal important change (MIC) (cohort and individual), the patient-acceptable symptom state (PASS) predictive of satisfaction, and the minimal detectable change at 90% confidence intervals (MDC-90). Results. The EQ-5D-3L demonstrated good internal consistency with an overall Cronbach alpha of 0.75 (preoperative) and 0.88 (postoperative), respectively. The MCID for the Index score was 0.085 (95% confidence interval (CI) 0.042 to 0.127) and EQ-VAS was 6.41 (95% CI 3.497 to 9.323). The MIC. COHORT. was 0.289 for the EQ-5D and 5.27 for the EQ-VAS. However, the MIC. INDIVIDUAL. for both the EQ-5D-3L Index (0.105) and EQ-VAS (-1) demonstrated poor-to-acceptable reliability. The MDC-90 was 0.023 for the EQ-5D-3L Index and 1.0 for the EQ-VAS. The PASS for the postoperative EQ-5D-3L Index and EQ-VAS scores predictive of patient satisfaction were 0.708 and 77.0, respectively. Conclusion. The meaningful values of the EQ-5D-3L Index and EQ-VAS scores can be used to measure clinically relevant changes in health-related quality of life in patients undergoing primary KA. Cite this article: Bone Joint Res 2022;11(9):619–628


The Bone & Joint Journal
Vol. 106-B, Issue 5 Supple B | Pages 3 - 10
1 May 2024
Heimann AF Murmann V Schwab JM Tannast M

Aims. The aim of this study was to investigate whether anterior pelvic plane-pelvic tilt (APP-PT) is associated with distinct hip pathomorphologies. We asked: is there a difference in APP-PT between young symptomatic patients being evaluated for joint preservation surgery and an asymptomatic control group? Does APP-PT vary among distinct acetabular and femoral pathomorphologies? And does APP-PT differ in symptomatic hips based on demographic factors?. Methods. This was an institutional review board-approved, single-centre, retrospective, case-control, comparative study, which included 388 symptomatic hips in 357 patients who presented to our tertiary centre for joint preservation between January 2011 and December 2015. Their mean age was 26 years (SD 2; 23 to 29) and 50% were female. They were allocated to 12 different morphological subgroups. The study group was compared with a control group of 20 asymptomatic hips in 20 patients. APP-PT was assessed in all patients based on supine anteroposterior pelvic radiographs using validated HipRecon software. Values in the two groups were compared using an independent-samples t-test. Multiple regression analysis was performed to examine the influences of diagnoses and demographic factors on APP-PT. The minimal clinically important difference (MCID) for APP-PT was defined as > 1 SD. Results. There were no significant differences in APP-PT between the control group and the overall group (1.1° (SD 3.0°; -4.9° to 5.9°) vs 1.8° (SD 3.4°; -6.9° to 13.2°); p = 0.323). Acetabular retroversion and overcoverage groups showed higher mean APP-PTs compared with the control group (p = 0.001 and p = 0.014) and were the only diagnoses with a significant influence on APP-PT in the stepwise multiple regression analysis. All differences were below the MCID. The age, sex, height, weight, and BMI showed no influence on APP-PT. Conclusion. APP-PT showed no radiologically significant variation across different pathomorphologies of the hip in patients being assessed for joint-preserving surgery. Cite this article: Bone Joint J 2024;106-B(5 Supple B):3–10


Bone & Joint Open
Vol. 3, Issue 7 | Pages 573 - 581
1 Jul 2022
Clement ND Afzal I Peacock CJH MacDonald D Macpherson GJ Patton JT Asopa V Sochart DH Kader DF

Aims. The aims of this study were to assess mapping models to predict the three-level version of EuroQoL five-dimension utility index (EQ-5D-3L) from the Oxford Knee Score (OKS) and validate these before and after total knee arthroplasty (TKA). Methods. A retrospective cohort of 5,857 patients was used to create the prediction models, and a second cohort of 721 patients from a different centre was used to validate the models, all of whom underwent TKA. Patient characteristics, BMI, OKS, and EQ-5D-3L were collected preoperatively and one year postoperatively. Generalized linear regression was used to formulate the prediction models. Results. There were significant correlations between the OKS and EQ-5D-3L preoperatively (r = 0.68; p < 0.001) and postoperatively (r = 0.77; p < 0.001) and for the change in the scores (r = 0.61; p < 0.001). Three different models (preoperative, postoperative, and change) were created. There were no significant differences between the actual and predicted mean EQ-5D-3L utilities at any timepoint or for change in the scores (p > 0.090) in the validation cohort. There was a significant correlation between the actual and predicted EQ-5D-3L utilities preoperatively (r = 0.63; p < 0.001) and postoperatively (r = 0.77; p < 0.001) and for the change in the scores (r = 0.56; p < 0.001). Bland-Altman plots demonstrated that a lower utility was overestimated, and higher utility was underestimated. The individual predicted EQ-5D-3L that was within ± 0.05 and ± 0.010 (minimal clinically important difference (MCID)) of the actual EQ-5D-3L varied between 13% to 35% and 26% to 64%, respectively, according to timepoint assessed and change in the scores, but was not significantly different between the modelling and validation cohorts (p ≥ 0.148). Conclusion. The OKS can be used to estimate EQ-5D-3L. Predicted individual patient utility error beyond the MCID varied from one-third to two-thirds depending on timepoint assessed, but the mean for a cohort did not differ and could be employed for this purpose. Cite this article: Bone Jt Open 2022;3(7):573–581


Bone & Joint Research
Vol. 1, Issue 5 | Pages 71 - 77
1 May 2012
Keurentjes JC Van Tol FR Fiocco M Schoones JW Nelissen RG

Objectives. We aimed first to summarise minimal clinically important differences (MCIDs) after total hip (THR) or knee replacement (TKR) in health-related quality of life (HRQoL), measured using the Short-Form 36 (SF-36). Secondly, we aimed to improve the precision of MCID estimates by means of meta-analysis. Methods. We conducted a systematic review of English and non-English articles using MEDLINE, the Cochrane Controlled Trials Register (1960–2011), EMBASE (1991–2011), Web of Science, Academic Search Premier and Science Direct. Bibliographies of included studies were searched in order to find additional studies. Search terms included MCID or minimal clinically important change, THR or TKR and Short-Form 36. We included longitudinal studies that estimated MCID of SF-36 after THR or TKR. Results. Three studies met our inclusion criteria, describing a distinct study population: primary THR, primary TKR and revision THR. No synthesis of study results can be given. Conclusions. Although we found MCIDs in HRQoL after THR or TKR have limited precision and are not validated using external criteria, these are still the best known estimates of MCIDs in HRQoL after THR and TKR to date. We therefore advise these MCIDs to be used as absolute thresholds, but with caution


The Bone & Joint Journal
Vol. 101-B, Issue 7 | Pages 832 - 837
1 Jul 2019
Shim J Hamilton DF

Aims. Responsiveness to clinically important change is a key feature of any outcome measure. Throughout Europe, health-related quality of life following total knee arthroplasty (TKA) is routinely measured with EuroQol five-dimension (EQ-5D) questionnaires. The Patient-Reported Outcomes Measurement Information System 10-Question Short-Form (PROMIS-10 Global Health) score is a new general heath outcome tool which is thought to offer greater responsiveness. Our aim was to compare these two tools. Patients and Methods. We accessed data from a prospective multicentre cohort study in the United Kingdom, which evaluated outcomes following TKA. The median age of the 721 patients was 69.0 years (interquartile range, 63.3 to 74.6). There was an even division of sex, and approximately half were educated to secondary school level. The preoperative EQ-5D, PROMIS-10, and Oxford Knee Scores (OKS) were available and at three, six, and 12 months postoperatively. Internal responsiveness was assessed by standardized response mean (SRM) and effect size (Cohen’s d). External responsiveness was assessed by correlating change scores of the EQ-5D and PROMIS-10, with the minimal clinically important difference (MCID) of the OKS. Receiver operating characteristic (ROC) curves were used to assess the ability of change scores to discriminate between improved and non-improved patients. Results. All measures showed significant changes between the preoperative score and the various postoperative times (p < 0.001). Most improvement occurred during the first three months, with small but significant changes between three and six months, and no further change between six and 12 months postoperatively. SRM scores for EQ-5D, PROMIS-10, and OKS were large (> 0.8). ROC curves showed that both EQ-5D and PROMIS-10 were able to discriminate between patients who achieved the OKS MCID and those who did not (area under the curve (AUC) of 0.7 to 0.82). Conclusion. The PROMIS-10 physical health tool showed greater responsiveness to change than the EQ-5D, most probably due to the additional questions on physical health parameters that are more susceptible to modification following TKA. The EQ-5D was, however, shown to be sensitive to clinically meaningful change following TKA, and provides the additional ability to calculate health economic utility scores. It is likely, therefore, that EQ-5D will continue to be the global health metric of choice in the United Kingdom. Cite this article: Bone Joint J 2019;101-B:832–837


Bone & Joint 360
Vol. 4, Issue 2 | Pages 32 - 34
1 Apr 2015

The April 2015 Research Roundup360 looks at: MCID in grip strength and distal radial fracture; Experiencing rehab in a trial setting; Electrical stimulation and nerve recovery; Molecular diagnosis of TB?; Acetabular orientation: component and arthritis; Analgesia after knee arthroplasty; Bisphosphonate-associated femoral fractures


Bone & Joint Open
Vol. 3, Issue 10 | Pages 786 - 794
12 Oct 2022
Harrison CJ Plummer OR Dawson J Jenkinson C Hunt A Rodrigues JN

Aims

The aim of this study was to develop and evaluate machine-learning-based computerized adaptive tests (CATs) for the Oxford Hip Score (OHS), Oxford Knee Score (OKS), Oxford Shoulder Score (OSS), and the Oxford Elbow Score (OES) and its subscales.

Methods

We developed CAT algorithms for the OHS, OKS, OSS, overall OES, and each of the OES subscales, using responses to the full-length questionnaires and a machine-learning technique called regression tree learning. The algorithms were evaluated through a series of simulation studies, in which they aimed to predict respondents’ full-length questionnaire scores from only a selection of their item responses. In each case, the total number of items used by the CAT algorithm was recorded and CAT scores were compared to full-length questionnaire scores by mean, SD, score distribution plots, Pearson’s correlation coefficient, intraclass correlation (ICC), and the Bland-Altman method. Differences between CAT scores and full-length questionnaire scores were contextualized through comparison to the instruments’ minimal clinically important difference (MCID).


Bone & Joint Open
Vol. 3, Issue 10 | Pages 804 - 814
13 Oct 2022
Grammatopoulos G Laboudie P Fischman D Ojaghi R Finless A Beaulé PE

Aims

The primary aim of this study was to determine the ten-year outcome following surgical treatment for femoroacetabular impingement (FAI). We assessed whether the evolution of practice from open to arthroscopic techniques influenced outcomes and tested whether any patient, radiological, or surgical factors were associated with outcome.

Methods

Prospectively collected data of a consecutive single-surgeon cohort, operated for FAI between January 2005 and January 2015, were retrospectively studied. The cohort comprised 393 hips (365 patients; 71% male (n = 278)), with a mean age of 34.5 years (SD 10.0). Over the study period, techniques evolved from open surgical dislocation (n = 94) to a combined arthroscopy-Hueter technique (HA + Hueter; n = 61) to a pure arthroscopic technique (HA; n = 238). Outcome measures of interest included modes of failures, complications, reoperation, and patient-reported outcome measures (PROMs). Demographic, radiological, and surgical factors were tested for possible association with outcome.


Bone & Joint Open
Vol. 5, Issue 3 | Pages 202 - 209
11 Mar 2024
Lewin AM Cashman K Harries D Ackerman IN Naylor JM Harris IA

Aims

The aim of this study was to describe and compare joint-specific and generic health-related quality of life outcomes of the first versus second knee in patients undergoing staged bilateral total knee arthroplasty (BTKA) for osteoarthritis.

Methods

This retrospective cohort study used Australian national arthroplasty registry data from January 2013 to January 2021 to identify participants who underwent elective staged BTKA with six to 24 months between procedures. The primary outcome was Oxford Knee Score (OKS) at six months postoperatively for the first TKA compared to the second TKA, adjusted for age and sex. Secondary outcomes compared six-month EuroQol five-dimension five-level (EQ-5D-5L) domain scores, EQ-5D index scores, and the EQ visual analogue scale (EQ-VAS) between knees at six months postoperatively.


Bone & Joint Open
Vol. 5, Issue 10 | Pages 911 - 919
21 Oct 2024
Clement N MacDonald DJ Hamilton DF Gaston P

Aims

The aims were to assess whether joint-specific outcome after total knee arthroplasty (TKA) was influenced by implant design over a 12-year follow-up period, and whether patient-related factors were associated with loss to follow-up and mortality risk.

Methods

Long-term follow-up of a randomized controlled trial was undertaken. A total of 212 patients were allocated a Triathlon or a Kinemax TKA. Patients were assessed preoperatively, and one, three, eight, and 12 years postoperatively using the Oxford Knee Score (OKS). Reasons for patient lost to follow-up, mortality, and revision were recorded.


The Bone & Joint Journal
Vol. 105-B, Issue 6 | Pages 711 - 716
1 Jun 2023
Ali MS Khattak M Metcalfe D Perry DC

Aims

This study aimed to evaluate the relationship between hip shape and mid-term function in Perthes’ disease. It also explored whether the modified three-group Stulberg classification can offer similar prognostic information to the five-group system.

Methods

A total of 136 individuals aged 12 years or older who had Perthes’ disease in childhood completed the Patient-Reported Outcomes Measurement Information System (PROMIS) Mobility score (function), Nonarthritic Hip Score (NAHS) (function), EuroQol five-dimension five-level questionnaire (EQ-5D-5L) score (quality of life), and the numeric rating scale for pain (NRS). The Stulberg class of the participants’ hip radiographs were evaluated by three fellowship-trained paediatric orthopaedic surgeons. Hip shape and Stulberg class were compared to PROM scores.


Bone & Joint Open
Vol. 3, Issue 9 | Pages 692 - 700
2 Sep 2022
Clement ND Smith KM Baron YJ McColm H Deehan DJ Holland J

Aims

The primary aim of our study was to assess the influence of age on hip-specific outcome following total hip arthroplasty (THA). Secondary aims were to assess health-related quality of life (HRQoL) and level of activity according to age.

Methods

A prospective cohort study was conducted. All patients were fitted with an Exeter stem with a 32 mm head on highly cross-linked polyethylene (X3RimFit) cemented acetabulum. Patients were recruited into three age groups: < 65 years, 65 to 74 years, and ≥ 75 years, and assessed preoperatively and at three, 12, 24, and 60 months postoperatively. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Harris Hip Score (HHS), and Hip disability and Osteoarthritis Outcome Score (HOOS), were used to assess hip-specific outcome. EuroQol five-dimension five-level questionnaire (EQ-5D-5L) and 36-Item Short Form Survey (SF-36) scores were used to assess HRQoL. The Lower Extremity Activity Scale (LEAS) and Timed Up and Go (TUG) were used to assess level of activity.


Bone & Joint Open
Vol. 3, Issue 10 | Pages 841 - 849
27 Oct 2022
Knight R Keene DJ Dutton SJ Handley R Willett K

Aims

The rationale for exacting restoration of skeletal anatomy after unstable ankle fracture is to improve outcomes by reducing complications from malunion; however, current definitions of malunion lack confirmatory clinical evidence.

Methods

Radiological (absolute radiological measurements aided by computer software) and clinical (clinical interpretation of radiographs) definitions of malunion were compared within the Ankle Injury Management (AIM) trial cohort, including people aged ≥ 60 years with an unstable ankle fracture. Linear regressions were used to explore the relationship between radiological malunion (RM) at six months and changes in function at three years. Function was assessed with the Olerud-Molander Ankle Score (OMAS), with a minimal clinically important difference set as six points, as per the AIM trial. Piecewise linear models were used to investigate new radiological thresholds which better explain symptom impact on ankle function.


Bone & Joint Open
Vol. 5, Issue 10 | Pages 937 - 943
22 Oct 2024
Gregor RH Hooper GJ Frampton C

Aims

The aim of this study was to determine whether obesity had a detrimental effect on the long-term performance and survival of medial unicompartmental knee arthroplasties (UKAs).

Methods

This study reviewed prospectively collected functional outcome scores and revision rates of all medial UKA patients with recorded BMI performed in Christchurch, New Zealand, from January 2011 to September 2021. Patient-reported outcome measures (PROMs) were the primary outcome of this study, with all-cause revision rate analyzed as a secondary outcome. PROMs were taken preoperatively, at six months, one year, five years, and ten years postoperatively. There were 873 patients who had functional scores recorded at five years and 164 patients had scores recorded at ten years. Further sub-group analysis was performed based on the patient’s BMI. Revision data were available through the New Zealand Joint Registry for 2,323 UKAs performed during this time period.


Bone & Joint Open
Vol. 4, Issue 12 | Pages 957 - 963
18 Dec 2023
van den Heuvel S Penning D Sanders F van Veen R Sosef N van Dijkman B Schepers T

Aims

The primary aim of this study was to present the mid-term follow-up of a multicentre randomized controlled trial (RCT) which compared the functional outcome following routine removal (RR) to the outcome following on-demand removal (ODR) of the syndesmotic screw (SS).

Methods

All patients included in the ‘ROutine vs on DEmand removal Of the syndesmotic screw’ (RODEO) trial received the Olerud-Molander Ankle Score (OMAS), American Orthopaedic Foot and Ankle Hindfoot Score (AOFAS), Foot and Ankle Outcome Score (FAOS), and EuroQol five-dimension questionnaire (EQ-5D). Out of the 152 patients, 109 (71.7%) completed the mid-term follow-up questionnaire and were included in this study (53 treated with RR and 56 with ODR). Median follow-up was 50 months (interquartile range 43.0 to 56.0) since the initial surgical treatment of the acute syndesmotic injury. The primary outcome of this study consisted of the OMAS scores of the two groups.


Bone & Joint Open
Vol. 5, Issue 7 | Pages 534 - 542
1 Jul 2024
Woods A Howard A Peckham N Rombach I Saleh A Achten J Appelbe D Thamattore P Gwilym SE

Aims

The primary aim of this study was to assess the feasibility of recruiting and retaining patients to a patient-blinded randomized controlled trial comparing corticosteroid injection (CSI) to autologous protein solution (APS) injection for the treatment of subacromial shoulder pain in a community care setting. The study focused on recruitment rates and retention of participants throughout, and collected data on the interventions’ safety and efficacy.

Methods

Participants were recruited from two community musculoskeletal treatment centres in the UK. Patients were eligible if aged 18 years or older, and had a clinical diagnosis of subacromial impingement syndrome which the treating clinician thought was suitable for treatment with a subacromial injection. Consenting patients were randomly allocated 1:1 to a patient-blinded subacromial injection of CSI (standard care) or APS. The primary outcome measures of this study relate to rates of recruitment, retention, and compliance with intervention and follow-up to determine feasibility. Secondary outcome measures relate to the safety and efficacy of the interventions.