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Bone & Joint Open
Vol. 2, Issue 12 | Pages 1089 - 1095
21 Dec 2021
Luo W Ali MS Limb R Cornforth C Perry DC

Aims

The Patient-Reported Outcomes Measurement Information System (PROMIS) has demonstrated faster administration, lower burden of data capture and reduced floor and ceiling effects compared to traditional Patient Reported Outcomes Measurements (PROMs). We investigated the suitability of PROMIS Mobility score in assessing physical function in the sequelae of childhood hip disease.

Methods

In all, 266 adolscents (aged ≥ 12 years) and adults were identified with a prior diagnosis of childhood hip disease (either Perthes’ disease (n = 232 (87.2%)) or Slipped Capital Femoral Epiphysis (n = 34 (12.8%)) with a mean age of 27.73 years (SD 12.24). Participants completed the PROMIS Mobility Computer Adaptive Test, the Non-Arthritic Hip Score (NAHS), EuroQol five-dimension five-level questionnaire, and the Numeric Pain Rating Scale. We investigated the correlation between the PROMIS Mobility and other tools to assess use in this population and any clustering of outcome scores.


Bone & Joint Open
Vol. 3, Issue 11 | Pages 898 - 906
15 Nov 2022
Dakin H Rombach I Dritsaki M Gray A Ball C Lamb SE Nanchahal J

Aims

To estimate the potential cost-effectiveness of adalimumab compared with standard care alone for the treatment of early-stage Dupuytren’s disease (DD) and the value of further research from an NHS perspective.

Methods

We used data from the Repurposing anti-TNF for Dupuytren’s disease (RIDD) randomized controlled trial of intranodular adalimumab injections in patients with early-stage progressive DD. RIDD found that intranodular adalimumab injections reduced nodule hardness and size in patients with early-stage DD, indicating the potential to control disease progression. A within-trial cost-utility analysis compared four adalimumab injections with no further treatment against standard care alone, taking a 12-month time horizon and using prospective data on EuroQol five-dimension five-level questionnaire (EQ-5D-5L) and resource use from the RIDD trial. We also developed a patient-level simulation model similar to a Markov model to extrapolate trial outcomes over a lifetime using data from the RIDD trial and a literature review. This also evaluated repeated courses of adalimumab each time the nodule reactivated (every three years) in patients who initially responded.


The Bone & Joint Journal
Vol. 102-B, Issue 11 | Pages 1542 - 1548
2 Nov 2020
Stirling PHC Oliver WM Ling Tan H Brown IDM Oliver CW McQueen MM Molyneux SG Duckworth AD

Aims. The primary aim of this study was to describe patient satisfaction and health-related quality of life (HRQoL) following corrective osteotomy for a symptomatic malunion of the distal radius. Methods. We retrospectively identified 122 adult patients from a single centre over an eight-year period who had undergone corrective osteotomy for a symptomatic malunion of the distal radius. The primary long-term outcome was the Patient-Rated Wrist Evaluation (PRWE) score. Secondary outcomes included the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) score, the EQ-5D-5L score, complications, and the Net Promoter Score (NPS). Multivariate regression analysis was used to determine factors associated with the PRWE score. Results. Long-term outcomes were available for 89 patients (72%). The mean age was 57 years (SD 15) and 68 were female (76%). The median time from injury to corrective osteotomy was nine months (interquartile range (IQR) 6 to 13). At a mean follow-up of six years (1 to 11) the median PRWE score was 22 (IQR 7 to 40), the median QuickDASH score was 11.4 (IQR 2.3 to 31.8), and the median EQ-5D-5L score was 0.84 (IQR 0.69 to 1). The NPS was 69. Multivariate regression analysis showed that the presence of an associated ulnar styloid fracture was the only significant independent factor associated with a worse PRWE score when adjusting for confounding variables (p = 0.004). Conclusion. We found that corrective osteotomy for malunion of the distal radius can result in good functional outcomes and high levels of patient satisfaction. However, the presence of an ulnar styloid fracture may adversely affect function. Level of Evidence: III (cohort study). Cite this article: Bone Joint J 2020;102-B(11):1542–1548


The Bone & Joint Journal
Vol. 103-B, Issue 5 | Pages 881 - 887
1 May 2021
Griffin XL Achten J Parsons N Costa ML

Aims. The aim of this study was to determine whether national standards of best practice are associated with improved health-related quality of life (HRQoL) outcomes in hip fracture patients. Methods. This was a multicentre cohort study conducted in 20 acute UK NHS hospitals treating hip fracture patients. Patients aged ≥ 60 years treated operatively for a hip fracture were eligible for inclusion. Regression models were fitted to each of the “Best Practice Tariff” indicators and overall attainment. The impact of attainment on HRQoL was assessed by quantifying improvement in EuroQol five-dimension five-level questionnaire (EQ-5D-5L) from estimated regression model coefficients. Results. A total of 6,532 patients provided both baseline and four-month EQ-5D-5L, of whom 1,060 participants had died at follow-up. Best practice was achieved in the care of 57% of participants; there was no difference in age, cognitive ability, and mobility at baseline for the overall attainment and non-attainment groups. Attaining at least ‘joint care by surgeon and orthogeriatrician’, ‘delirium assessment’, and ‘falls assessment’ was associated with a large, clinically relevant increase in four months EQ-5D-5L of 0.094 (bootstrapped 95% confidence interval (CI) 0.046 to 0.146). Conclusion. National standards with enhanced remuneration in hip fracture care results in improvement in individual patients’ HRQoL. Cite this article: Bone Joint J 2021;103-B(5):881–887


Aims. Surgical treatment of hip fracture is challenging; the bone is porotic and fixation failure can be catastrophic. Novel implants are available which may yield superior clinical outcomes. This study compared the clinical effectiveness of the novel X-Bolt Hip System (XHS) with the sliding hip screw (SHS) for the treatment of fragility hip fractures. Methods. We conducted a multicentre, superiority, randomized controlled trial. Patients aged 60 years and older with a trochanteric hip fracture were recruited in ten acute UK NHS hospitals. Participants were randomly allocated to fixation of their fracture with XHS or SHS. A total of 1,128 participants were randomized with 564 participants allocated to each group. Participants and outcome assessors were blind to treatment allocation. The primary outcome was the EuroQol five-dimension five-level health status (EQ-5D-5L) utility at four months. The minimum clinically important difference in utility was pre-specified at 0.075. Secondary outcomes were EQ-5D-5L utility at 12 months, mortality, residential status, mobility, revision surgery, and radiological measures. Results. Overall, 437 and 443 participants were analyzed in the primary intention-to-treat analysis in XHS and SHS treatment groups respectively. There was a mean difference of 0.029 in adjusted utility index in favour of XHS with no evidence of a difference between treatment groups (95% confidence interval -0.013 to 0.070; p = 0.175). There was no evidence of any differences between treatment groups in any of the secondary outcomes. The pattern and overall risk of adverse events associated with both treatments was similar. Conclusion. Any difference in four-month health-related quality of life between the XHS and SHS is small and not clinically important. There was no evidence of a difference in the safety profile of the two treatments; both were associated with lower risks of revision surgery than previously reported. Cite this article: Bone Joint J 2021;103-B(2):256–263


Aims. Describe a statistical and economic analysis plan for the Distal Radius Acute Fracture Fixation Trial 2 (DRAFFT2) randomized controlled trial. Methods. DRAFFT2 is a multicentre, parallel, two-arm randomized controlled trial. It compares surgical fixation with K-wires versus plaster cast in adult patients who have sustained a dorsally displaced fracture of the distal radius. The primary outcome measure is the Patient-Rated Wrist Evaluation (PRWE, a validated assessment of wrist function and pain) at 12 months post-randomization. Secondary outcomes are measured at three, six, and 12 months after randomization and include the PWRE, EuroQoL EQ-5D-5L index and EQ-VAS (visual analogue scale), complication rate, and cost-effectiveness of the treatment. Results. This paper describes the full details of the planned methods of analysis and descriptive statistics. The DRAFFT2 study protocol has been published previously. Conclusion. The planned analysis strategy described records our intent to conduct statistical and within-trial cost-utility analyses. Cite this article: Bone Joint Open 2020;1-6:245–252


The Bone & Joint Journal
Vol. 103-B, Issue 3 | Pages 553 - 561
1 Mar 2021
Smolle MA Leithner A Kapper M Demmer G Trost C Bergovec M Windhager R Hobusch GM

Aims. The aims of the study were to analyze differences in surgical and oncological outcomes, as well as quality of life (QoL) and function in patients with ankle sarcomas undergoing three forms of surgical treatment, minor or major limb salvage surgery (LSS), or amputation. Methods. A total of 69 patients with ankle sarcomas, treated between 1981 and 2017 at two tumour centres, were retrospectively reviewed (mean age at surgery: 46.3 years (SD 22.0); 31 females (45%)). Among these 69 patients 25 were analyzed prospectively (mean age at latest follow-up: 61.2 years (SD 20.7); 11 females (44%)), and assessed for mobility using the Prosthetic Limb Users Survey of Mobility (PLUS-M; for amputees only), the Toronto Extremity Salvage Score (TESS), and the University of California, Los Angeles (UCLA) Activity Score. Individual QoL was evaluated in these 25 patients using the five-level EuroQol five-dimension (EQ-5D-5L) and Fragebogen zur Lebenszufriedenheit/Questions on Life Satisfaction (FLZ). Results. Of the total number of patients in the study, 22 (32%) underwent minor LSS and 22 (32%) underwent major LSS; 25 underwent primary amputation (36%). Complications developed in 26 (38%) patients, and were more common in those with major or minor LSS in comparison to amputation (59% vs 36% vs 20%; p = 0.022). A time-dependent trend towards higher complication risk following any LSS was present (relative risk: 0.204; 95% confidence interval (CI) 0.026 to 1.614; p = 0.095). In the prospective cohort, mean TESS was higher following minor LSS in comparison to amputation (91.0 vs 67.3; p = 0.006), while there was no statistically significant difference between major LSS and amputation (81.6 vs 67.3; p = 0.099). There was no difference in mean UCLA (p = 0.334) between the three groups (p = 0.334). None of the items in FLZ or EQ-5D-5L were different between the three groups (all p > 0.05), except for FLZ item “self-relation”, being lower in amputees. Conclusion. Complications are common following LSS for ankle sarcomas. QoL is comparable between patients with LSS or amputation, despite better mobility scores for patients following minor LSS. We conclude that these results allow a decision for amputation to be made more easily in patients particularly where the principles of oncological surgery would otherwise be at risk. Cite this article: Bone Joint J 2021;103-B(3):553–561


The Bone & Joint Journal
Vol. 103-B, Issue 2 | Pages 247 - 255
1 Feb 2021
Hassellund SS Williksen JH Laane MM Pripp A Rosales CP Karlsen Ø Madsen JE Frihagen F

Aims. To compare operative and nonoperative treatment for displaced distal radius fractures in patients aged over 65 years. Methods. A total of 100 patients were randomized in this non-inferiority trial, comparing cast immobilization with operation with a volar locking plate. Patients with displaced AO/OTA A and C fractures were eligible if one of the following were found after initial closed reduction: 1) dorsal angulation > 10°; 2) ulnar variance > 3 mm; or 3) intra-articular step-off > 2 mm. Primary outcome measure was the abbreviated version of the Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH) after 12 months. Secondary outcome measures were the Patient-Rated Wrist and Hand Evaluation (PRWHE), EuroQol-5 dimensions 5-level questionnaire (EQ-5D-5L), range of motion (ROM), grip strength, “satisfaction with wrist function” (score 0 to 10), and complications. Results. In all, 89 women and 11 men were included. Mean age was 74 years (65 to 91). Nonoperative treatment was non-inferior to operation with a five-point difference in median QuickDASH after 12 months (p = 0.206). After three and six months QuickDASH favoured the operative group (p = 0.010 and 0.030). Median values for PRWHE were 19 (interquartile range (IRQ) 10 to 32) in the operative group versus ten (IQR 1 to 31) in the nonoperative group at three months (p = 0.064), nine (IQR 2 to 20) versus five (IQR 0 to 13) (p = 0.020) at six months, and two (IQR 0 to 12) versus zero (IQR 0 to 8) (p = 0.019) after 12 months. Range of motion was similar between the groups. The EQ-5D-5L index score was better (mean difference 0.07) in the operative group at three and 12 months (p = 0.008 and 0.020). The complication rate was similar (p = 0.220). The operated patients were more satisfied with wrist function (median 8 (IQR 6 to 9) vs 6 (IQR 5 to 7) at three months, p = 0.002; 9 (IQR 7 to 9) vs 8 (IQR 6 to 8) at six months, p = 0.002; and 10 (IQR 8 to 10) vs 8 (IQR 7 to 9) at 12 months, p < 0.001). Conclusion. Nonoperative treatment was non-inferior to operative treatment based on QuickDASH after one year. Patients in the operative group had a faster recovery and were more satisfied with wrist function. Results from previous trials comparing operative and nonoperative treatment for displaced distal radius fractures in the elderly vary between favouring the operative group and showing similar results between the treatments. This randomized trial suggests that most elderly patients may be treated nonoperatively. Cite this article: Bone Joint J 2021;103-B(2):247–255


The Bone & Joint Journal
Vol. 102-B, Issue 7 | Pages 933 - 940
1 Jul 2020
Maempel JF Clement ND Wickramasinghe NR Duckworth AD Keating JF

Aims. The aim was to compare long-term patient-reported outcome measures (PROMs) after operative and nonoperative treatment of acute Achilles tendon rupture in the context of a randomized controlled trial. Methods. PROMs including the Short Musculoskeletal Function Assessment (SMFA), Achilles Tendon Total Rupture Score (ATRS), EuroQol five-dimension (EQ-5D), satisfaction, net promoter score and data regarding re-rupture, and venous thromboembolic rates were collected for patients randomized to receive either operative or nonoperative treatment for acute Achilles tendon rupture in a previous study. Of the 80 patients originally randomized, 64 (33 treated surgically, 31 nonoperatively) patients were followed up at a mean of 15.7 years (13.4 to 17.7). Results. There was no statistically significant difference between operatively and nonoperatively treated patients, in SMFA Dysfunction Index (median 1.56 (interquartile range (IQR) 0 to 5.51) vs 1.47 (IQR 0 to 5.15); p = 0.289), SMFA Bother Index (2.08 (IQR 0 to 12.50) vs 0.00 (IQR 0 to 6.25); p = 0.074), ATRS (94 (IQR 86 to 100) vs 95 (IQR 81 to 100); p = 0.313), EQ-5D-5L (1 (IQR 0.75 to 1) vs 1 (IQR 0.84 to 1); p = 0.137) or EQ-5D health today visual analogue score (85 (IQR 72.5 to 95) vs 85 (IQR 8 to 95); p = 0.367). There was no statistically significant difference between operative and nonoperative groups in terms of satisfaction (84% vs 100%; p = 0.119) or willingness to recommend treatment to friends or family (79% vs 87%; p = 0.255). Four nonoperative patients and two in the operative group sustained a re-rupture (p = 0.306). Conclusion. Both patient groups reported good results at long-term follow-up. The findings give no evidence of superior long-term patient reported outcomes (as measured by the SMFA) for surgical treatment over nonoperative treatment. There was no demonstrable difference in other patient reported outcome measures, satisfaction, or re-rupture rates at long-term follow-up. Cite this article: Bone Joint J 2020;102-B(7):933–940


The Bone & Joint Journal
Vol. 102-B, Issue 2 | Pages 155 - 161
1 Feb 2020
McMahon SE Diamond OJ Cusick LA

Aims. Complex displaced osteoporotic acetabular fractures in the elderly are associated with high levels of morbidity and mortality. Surgical options include either open reduction and internal fixation alone, or combined with total hip arthroplasty (THA). There remains a cohort of severely comorbid patients who are deemed unfit for extensive surgical reconstruction and are treated conservatively. We describe the results of a coned hemipelvis reconstruction and THA inserted via a posterior approach to the hip as the primary treatment for this severely high-risk cohort. Methods. We have prospectively monitored a series of 22 cases (21 patients) with a mean follow-up of 32 months (13 to 59). Results. The mean patient age was 79 years (67 to 87), and the mean ASA score was 3.3 (3 to 5). Three patients had high-energy injuries and 18 had low-energy injuries. All cases were associated fractures (Letournel classification: anterior column posterior hemitransverse, n = 13; associated both column, n = 6; transverse posterior wall, n = 3) with medialization of the femoral head. Mean operative time was 93 minutes (61 to 135). There have been no revisions to date. Of the 21 patients, 20 were full weight-bearing on day 1 postoperatively. Mean length of hospital stay was 12 days (5 to 27). Preoperative mobility status was maintained in 13 patients. At one year, mean Merle d’Aubigné score was 13.1 (10 to 18), mean Oxford Hip Score was 38.5 (24 to 44), mean EuroQol five-dimension five-level (EQ-5D-5L) health score was 68 (30 to 92), and mean EQ-5D-5L index score was 0.68 (0.335 to 0.837); data from 14 patients. Mortality was 9.5% (2/21) at one year. There have been no thromboembolic events, deep infections, or revisions. Conclusion. The coned hemipelvis reconstruction bypasses the fracture, creating an immediately stable construct that allows immediate full weight-bearing. The posterior approach minimizes the operative time and physiological insult in this vulnerable patient population. Early results suggest this to be a safe addition to current surgical options, targeted at the most medically frail elderly patient with a complex displaced acetabular fracture. Cite this article: Bone Joint J 2020;102-B(2):155–161


Aims. This study aimed to compare the change in health-related quality of life of patients receiving a traditional cemented monoblock Thompson hemiarthroplasty compared with a modern cemented modular polished-taper stemmed hemiarthroplasty for displaced intracapsular hip fractures. Patients and Methods. This was a pragmatic, multicentre, multisurgeon, two-arm, parallel group, randomized standard-of-care controlled trial. It was embedded within the WHiTE Comprehensive Cohort Study. The sample size was 964 patients. The setting was five National Health Service Trauma Hospitals in England. A total of 964 patients over 60 years of age who required hemiarthroplasty of the hip between February 2015 and March 2016 were included. A standardized measure of health outcome, the EuroQol (EQ-5D-5L) questionnaire, was carried out on admission and at four months following the operation. Results. Of the 964 patients enrolled, 482 died or were lost to follow-up (50%). No significant differences were noted in EQ-5D between groups, with a mean difference at four months of 0.037 in favour of the Exeter/Unitrax implant (95% confidence interval (CI) 0.014 to 0.087, p = 0.156), rising to 0.045 (95% CI 0.007 to 0.098, p = 0.09) when patients who died were excluded. The minimum clinically important difference for EQ-5D-5L used in this study is 0.08, therefore any benefit between implants is unlikely to be noticeable to the patient. There was no difference in mortality or mobility score. Conclusion. Allowing for the high rate of loss to follow-up, the use of the traditional Thompson hemiarthroplasty in the treatment of the displaced intracapsular hip fracture shows no difference in health outcome when compared with a modern cemented hemiarthroplasty. Cite this article: Bone Joint J 2018;100-B:352–60


The Bone & Joint Journal
Vol. 106-B, Issue 9 | Pages 949 - 956
1 Sep 2024
Matthews PA Scammell BE Coughlin TA Nightingale J Ollivere BJ

Aims

This study aimed to compare the outcomes of two different postoperative management approaches following surgical fixation of ankle fractures: traditional cast immobilization versus the Early Motion and Directed Exercise (EMADE) programme.

Methods

A total of 157 patients aged 18 years or older who underwent successful open reduction and internal fixation (ORIF) of Weber B (AO44B) ankle fractures were recruited to this randomized controlled trial. At two weeks post-surgical fixation, participants were randomized to either light-weight cast-immobilization or the EMADE programme, consisting of progressive home exercises and weekly advice and education. Both groups were restricted to non-weightbearing until six weeks post-surgery. The primary outcome was assessed using the Olerud-Molander Ankle Score (OMAS) questionnaire at 12 weeks post-surgery, with secondary measures at two, six, 24, and 52 weeks. Exploratory cost-effectiveness analyses were also performed.


The Bone & Joint Journal
Vol. 105-B, Issue 10 | Pages 1045 - 1051
1 Oct 2023
Turgeon TR Righolt CH Burnell CD Gascoyne TC Hedden DR Bohm ER

Aims

The primary aim of this trial was to compare the subsidence of two similar hydroxyapatite-coated titanium femoral components from different manufacturers. Secondary aims were to compare rotational migration (anteversion/retroversion and varus/valgus tilt) and patient-reported outcome measures between both femoral components.

Methods

Patients were randomized to receive one of the two femoral components (Avenir or Corail) during their primary total hip arthroplasty between August 2018 and September 2020. Radiostereometric analysis examinations at six, 12, and 24 months were used to assess the migration of each implanted femoral component compared to a baseline assessment. Patient-reported outcome measures were also recorded for these same timepoints. Overall, 50 patients were enrolled (62% male (n = 31), with a mean age of 65.7 years (SD 7.3), and mean BMI of 30.2 kg/m2 (SD 5.2)).


Bone & Joint Open
Vol. 5, Issue 6 | Pages 499 - 513
20 Jun 2024
Keene DJ Achten J Forde C Png ME Grant R Draper K Appelbe D Tutton E Peckham N Dutton SJ Lamb SE Costa ML

Aims

Ankle fractures are common, mainly affecting adults aged 50 years and over. To aid recovery, some patients are referred to physiotherapy, but referral patterns vary, likely due to uncertainty about the effectiveness of this supervised rehabilitation approach. To inform clinical practice, this study will evaluate the effectiveness of supervised versus self-directed rehabilitation in improving ankle function for older adults with ankle fractures.

Methods

This will be a multicentre, parallel-group, individually randomized controlled superiority trial. We aim to recruit 344 participants aged 50 years and older with an ankle fracture treated surgically or non-surgically from at least 20 NHS hospitals. Participants will be randomized 1:1 using a web-based service to supervised rehabilitation (four to six one-to-one physiotherapy sessions of tailored advice and prescribed home exercise over three months), or self-directed rehabilitation (provision of advice and exercise materials that participants will use to manage their recovery independently). The primary outcome is participant-reported ankle-related symptoms and function six months after randomization, measured by the Olerud and Molander Ankle Score. Secondary outcomes at two, four, and six months measure health-related quality of life, pain, physical function, self-efficacy, exercise adherence, complications, and resource use. Due to the nature of the interventions, participants and intervention providers will be unblinded to treatment allocation.


The Bone & Joint Journal
Vol. 106-B, Issue 8 | Pages 808 - 816
1 Aug 2024
Hall AJ Cullinan R Alozie G Chopra S Greig L Clarke J Riches PE Walmsley P Ohly NE Holloway N

Aims

Total knee arthroplasty (TKA) with a highly congruent condylar-stabilized (CS) articulation may be advantageous due to increased stability versus cruciate-retaining (CR) designs, while mitigating the limitations of a posterior-stabilized construct. The aim was to assess ten-year implant survival and functional outcomes of a cemented single-radius TKA with a CS insert, performed without posterior cruciate ligament sacrifice.

Methods

This retrospective cohort study included consecutive patients undergoing TKA at a specialist centre in the UK between November 2010 and December 2012. Data were collected using a bespoke electronic database and cross-referenced with national arthroplasty audit data, with variables including: preoperative characteristics, intraoperative factors, complications, and mortality status. Patient-reported outcome measures (PROMs) were collected by a specialist research team at ten years post-surgery. There were 536 TKAs, of which 308/536 (57.5%) were in female patients. The mean age was 69.0 years (95% CI 45.0 to 88.0), the mean BMI was 32.2 kg/m2 (95% CI 18.9 to 50.2), and 387/536 (72.2%) survived to ten years. There were four revisions (0.7%): two deep infections (requiring debridement and implant retention), one aseptic loosening, and one haemosiderosis.


Bone & Joint Open
Vol. 5, Issue 12 | Pages 1049 - 1066
1 Dec 2024
Lister J James S Sharma HK Hewitt C Fulbright H Leggett H McDaid C

Aims

Lower limb reconstruction (LLR) has a profound impact on patients, affecting multiple areas of their lives. Many patient-reported outcome measures (PROMs) are employed to assess these impacts; however, there are concerns that they do not adequately capture all outcomes important to patients, and may lack content validity in this context. This review explored whether PROMs used with adults requiring, undergoing, or after undergoing LLR exhibited content validity and adequately captured outcomes considered relevant and important to patients.

Methods

A total of 37 PROMs were identified. Systematic searches were performed to retrieve content validity studies in the adult LLR population, and hand-searches used to find PROM development studies. Content validity assessments for each measure were performed following Consensus-based Standards for the selection of health measurement Instruments (COSMIN) guidelines. A mapping exercise compared all PROMs to a conceptual framework previously developed by the study team (‘the PROLLIT framework’) to explore whether each PROM covered important and relevant concepts.


Bone & Joint Open
Vol. 5, Issue 4 | Pages 343 - 349
22 Apr 2024
Franssen M Achten J Appelbe D Costa ML Dutton S Mason J Gould J Gray A Rangan A Sheehan W Singh H Gwilym SE

Aims

Fractures of the humeral shaft represent 3% to 5% of all fractures. The most common treatment for isolated humeral diaphysis fractures in the UK is non-operative using functional bracing, which carries a low risk of complications, but is associated with a longer healing time and a greater risk of nonunion than surgery. There is an increasing trend to surgical treatment, which may lead to quicker functional recovery and lower rates of fracture nonunion than functional bracing. However, surgery carries inherent risk, including infection, bleeding, and nerve damage. The aim of this trial is to evaluate the clinical and cost-effectiveness of functional bracing compared to surgical fixation for the treatment of humeral shaft fractures.

Methods

The HUmeral SHaft (HUSH) fracture study is a multicentre, prospective randomized superiority trial of surgical versus non-surgical interventions for humeral shaft fractures in adult patients. Participants will be randomized to receive either functional bracing or surgery. With 334 participants, the trial will have 90% power to detect a clinically important difference for the Disabilities of the Arm, Shoulder and Hand questionnaire score, assuming 20% loss to follow-up. Secondary outcomes will include function, pain, quality of life, complications, cost-effectiveness, time off work, and ability to drive.


Aims

Olecranon fractures are usually caused by falling directly on to the olecranon or following a fall on to an outstretched arm. Displaced fractures of the olecranon with a stable ulnohumeral joint are commonly managed by open reduction and internal fixation. The current predominant method of management of simple displaced fractures with ulnohumeral stability (Mayo grade IIA) in the UK and internationally is a low-cost technique using tension band wiring. Suture or suture anchor techniques have been described with the aim of reducing the hardware related complications and reoperation. An all-suture technique has been developed to fix the fracture using strong synthetic sutures alone. The aim of this trial is to investigate the clinical and cost-effectiveness of tension suture repair versus traditional tension band wiring for the surgical fixation of Mayo grade IIA fractures of the olecranon.

Methods

SOFFT is a multicentre, pragmatic, two-arm parallel-group, non-inferiority, randomized controlled trial. Participants will be assigned 1:1 to receive either tension suture fixation or tension band wiring. 280 adult participants will be recruited. The primary outcome will be the Disabilities of the Arm, Shoulder and Hand (DASH) score at four months post-randomization. Secondary outcome measures include DASH (at 12, 18, and 24 months), pain, Net Promotor Score (patient satisfaction), EuroQol five-dimension five-level score (EQ-5D-5L), radiological union, complications, elbow range of motion, and re-operations related to the injury or to remove metalwork. An economic evaluation will assess the cost-effectiveness of treatments.


Aims

The primary aim of this study was to report the radiological outcomes of patients with a dorsally displaced distal radius fracture who were randomized to a moulded cast or surgical fixation with wires following manipulation and closed reduction of their fracture. The secondary aim was to correlate radiological outcomes with patient-reported outcome measures (PROMs) in the year following injury.

Methods

Participants were recruited as part of DRAFFT2, a UK multicentre clinical trial. Participants were aged 16 years or over with a dorsally displaced distal radius fracture, and were eligible for the trial if they needed a manipulation of their fracture, as recommended by their treating surgeon. Participants were randomly allocated on a 1:1 ratio to moulded cast or Kirschner wires after manipulation of the fracture in the operating theatre. Standard posteroanterior and lateral radiographs were performed in the radiology department of participating centres at the time of the patient’s initial assessment in the emergency department and six weeks postoperatively. Intraoperative fluoroscopic images taken at the time of fracture reduction were also assessed.


The Bone & Joint Journal
Vol. 105-B, Issue 12 | Pages 1271 - 1278
1 Dec 2023
Rehman Y Korsvold AM Lerdal A Aamodt A

Aims

This study compared patient-reported outcomes of three total knee arthroplasty (TKA) designs from one manufacturer: one cruciate-retaining (CR) design, and two cruciate-sacrificing designs, anterior-stabilized (AS) and posterior-stabilized (PS).

Methods

Patients scheduled for primary TKA were included in a single-centre, prospective, three-armed, blinded randomized trial (n = 216; 72 per group). After intraoperative confirmation of posterior cruciate ligament (PCL) integrity, patients were randomly allocated to receive a CR, AS, or PS design from the same TKA system. Insertion of an AS or PS design required PCL resection. The primary outcome was the mean score of all five subscales of the Knee injury and Osteoarthritis Outcome Score (KOOS) at two-year follow-up. Secondary outcomes included all KOOS subscales, Oxford Knee Score, EuroQol five-dimension health questionnaire, EuroQol visual analogue scale, range of motion (ROM), and willingness to undergo the operation again. Patient satisfaction was also assessed.