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The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 4 | Pages 549 - 555
1 Apr 2012
Lefaivre KA Slobogean GP Valeriote J O’Brien PJ Macadam SA

We performed a systematic review of the literature to evaluate the use and interpretation of generic and disease-specific functional outcome instruments in the reporting of outcome after the surgical treatment of disruptions of the pelvic ring. A total of 28 papers met our inclusion criteria, with eight reporting only generic outcome instruments, 13 reporting only pelvis-specific outcome instruments, and six reporting both. The Short-Form 36 (SF-36) was by far the most commonly used generic outcome instrument, used in 12 papers, with widely variable reporting of scores. The pelvis-specific outcome instruments were used in 19 studies; the Majeed score in ten, Iowa pelvic score in six, Hannover pelvic score in two and the Orlando pelvic score in one. Four sets of authors, all testing construct validity based on correlation with the SF-36, performed psychometric testing of three pelvis-specific instruments (Majeed, IPS and Orlando scores). No testing of responsiveness, content validity, criterion validity, internal consistency or reproducibility was performed.

The existing literature in this area is inadequate to inform surgeons or patients in a meaningful way about the functional outcomes of these fractures after fixation.


The Bone & Joint Journal
Vol. 100-B, Issue 6 | Pages 693 - 702
1 Jun 2018
Jayakumar P Overbeek CL Vranceanu A Williams M Lamb S Ring D Gwilym S

Aims. Outcome measures quantifying aspects of health in a precise, efficient, and user-friendly manner are in demand. Computer adaptive tests (CATs) may overcome the limitations of established fixed scales and be more adept at measuring outcomes in trauma. The primary objective of this review was to gain a comprehensive understanding of the psychometric properties of CATs compared with fixed-length scales in the assessment of outcome in patients who have suffered trauma of the upper limb. Study designs, outcome measures and methodological quality are defined, along with trends in investigation. Materials and Methods. A search of multiple electronic databases was undertaken on 1 January 2017 with terms related to “CATs”, “orthopaedics”, “trauma”, and “anatomical regions”. Studies involving adults suffering trauma to the upper limb, and undergoing any intervention, were eligible. Those involving the measurement of outcome with any CATs were included. Identification, screening, and eligibility were undertaken, followed by the extraction of data and quality assessment using the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) criteria. The review is reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) criteria and reg. istered (PROSPERO: CRD42016053886). Results. A total of 31 studies reported trauma conditions alone, or in combination with non-traumatic conditions using CATs. Most were cross-sectional with varying level of evidence, number of patients, type of study, range of conditions and methodological quality. CATs correlated well with fixed scales and had minimal or no floor-ceiling effects. They required significantly fewer questions and/or less time for completion. Patient-Reported Outcomes Measurement Information System (PROMIS) CATs were the most frequently used, and the use of CATs is increasing. Conclusion. Early studies show valid and reliable outcome measurement with CATs performing as well as, if not better than, established fixed scales. Superior properties such as floor-ceiling effects and ease of use support their use in the assessment of outcome after trauma. As CATs are being increasingly used in patient outcomes research, further psychometric evaluation, especially involving longitudinal studies and groups of patients with specific injuries are required to inform clinical practice using these contemporary measures. Cite this article: Bone Joint J 2018;100-B:693–702


Bone & Joint Research
Vol. 4, Issue 12 | Pages 190 - 194
1 Dec 2015
Kleinlugtenbelt YV Hoekstra M Ham SJ Kloen P Haverlag R Simons MP Bhandari M Goslings JC Poolman RW Scholtes VAB

Objectives. Current studies on the additional benefit of using computed tomography (CT) in order to evaluate the surgeons’ agreement on treatment plans for fracture are inconsistent. This inconsistency can be explained by a methodological phenomenon called ‘spectrum bias’, defined as the bias inherent when investigators choose a population lacking therapeutic uncertainty for evaluation. The aim of the study is to determine the influence of spectrum bias on the intra-observer agreement of treatment plans for fractures of the distal radius. Methods. Four surgeons evaluated 51 patients with displaced fractures of the distal radius at four time points: T1 and T2: conventional radiographs; T3 and T4: radiographs and additional CT scan (radiograph and CT). Choice of treatment plan (operative or non-operative) and therapeutic certainty (five-point scale: very uncertain to very certain) were rated. To determine the influence of spectrum bias, the intra-observer agreement was analysed, using Kappa statistics, for each degree of therapeutic certainty. . Results. In cases with high therapeutic certainty, intra-observer agreement based on radiograph was almost perfect (0.86 to 0.90), but decreased to moderate based on a radiograph and CT (0.47 to 0.60). In cases with high therapeutic uncertainty, intra-observer agreement was slight at best (-0.12 to 0.19), but increased to moderate based on the radiograph and CT (0.56 to 0.57). Conclusion. Spectrum bias influenced the outcome of this agreement study on treatment plans. An additional CT scan improves the intra-observer agreement on treatment plans for a fracture of the distal radius only when there is therapeutic uncertainty. Reporting and analysing intra-observer agreement based on the surgeon’s level of certainty is an appropriate method to minimise spectrum bias. Cite this article: Bone Joint Res 2015;4:190–194


Bone & Joint Open
Vol. 4, Issue 2 | Pages 104 - 109
20 Feb 2023
Aslam AM Kennedy J Seghol H Khisty N Nicols TA Adie S

Aims

Patient decision aids have previously demonstrated an improvement in the quality of the informed consent process. This study assessed the effectiveness of detailed written patient information, compared to standard verbal consent, in improving postoperative recall in adult orthopaedic trauma patients.

Methods

This randomized controlled feasibility trial was conducted at two teaching hospitals within the South Eastern Sydney Local Health District. Adult patients (age ≥ 18 years) pending orthopaedic trauma surgery between March 2021 and September 2021 were recruited and randomized to detailed or standard methods of informed consent using a random sequence concealed in sealed, opaque envelopes. The detailed group received procedure-specific written information in addition to the standard verbal consent. The primary outcome was total recall, using a seven-point interview-administered recall questionnaire at 72 hours postoperatively. Points were awarded if the participant correctly recalled details of potential complications (maximum three points), implants used (maximum three points), and postoperative instructions (maximum one point). Secondary outcomes included the anxiety subscale of the Hospital and Anxiety Depression Scale (HADS-A) and visual analogue scale (VAS) for pain collected at 24 hours preoperatively and 72 hours postoperatively. Additionally, the Patient Satisfaction Questionnaire Short Form (PSQ-18) measured satisfaction at 72 hours postoperatively.


The Bone & Joint Journal
Vol. 106-B, Issue 9 | Pages 994 - 999
1 Sep 2024
El-Khaldi I Gude MH Gundtoft PH Viberg B

Aims

Pneumatic tourniquets are often used during the surgical treatment of unstable traumatic ankle fractures. The aim of this study was to assess the risk of reoperation after open reduction and internal fixation of ankle fractures with and without the use of pneumatic tourniquets.

Methods

This was a population-based cohort study using data from the Danish Fracture Database with a follow-up period of 24 months. Data were linked to the Danish National Patient Registry to ensure complete information regarding reoperations due to complications, which were divided into major and minor. The relative risk of reoperations for the tourniquet group compared with the non-tourniquet group was estimated using Cox proportional hazards modelling.


The Bone & Joint Journal
Vol. 105-B, Issue 11 | Pages 1201 - 1205
1 Nov 2023
Farrow L Clement ND Mitchell L Sattar M MacLullich AMJ

Aims

Surgery is often delayed in patients who sustain a hip fracture and are treated with a total hip arthroplasty (THA), in order to await appropriate surgical expertise. There are established links between delay and poorer outcomes in all patients with a hip fracture, but there is little information about the impact of delay in the less frail patients who undergo THA. The aim of this study was to investigate the influence of delayed surgery on outcomes in these patients.

Methods

A retrospective cohort study was undertaken using data from the Scottish Hip Fracture Audit between May 2016 and December 2020. Only patients undergoing THA were included, with categorization according to surgical treatment within 36 hours of admission (≤ 36 hours = ‘acute group’ vs > 36 hours = ‘delayed’ group). Those with delays due to being “medically unfit” were excluded. The primary outcome measure was 30-day survival. Costs were estimated in relation to the differences in the lengths of stay.


Bone & Joint Open
Vol. 5, Issue 3 | Pages 218 - 226
15 Mar 2024
Voigt JD Potter BK Souza J Forsberg J Melton D Hsu JR Wilke B

Aims

Prior cost-effectiveness analyses on osseointegrated prosthesis for transfemoral unilateral amputees have analyzed outcomes in non-USA countries using generic quality of life instruments, which may not be appropriate when evaluating disease-specific quality of life. These prior analyses have also focused only on patients who had failed a socket-based prosthesis. The aim of the current study is to use a disease-specific quality of life instrument, which can more accurately reflect a patient’s quality of life with this condition in order to evaluate cost-effectiveness, examining both treatment-naïve and socket refractory patients.

Methods

Lifetime Markov models were developed evaluating active healthy middle-aged male amputees. Costs of the prostheses, associated complications, use/non-use, and annual costs of arthroplasty parts and service for both a socket and osseointegrated (OPRA) prosthesis were included. Effectiveness was evaluated using the questionnaire for persons with a transfemoral amputation (Q-TFA) until death. All costs and Q-TFA were discounted at 3% annually. Sensitivity analyses on those cost variables which affected a change in treatment (OPRA to socket, or socket to OPRA) were evaluated to determine threshold values. Incremental cost-effectiveness ratios (ICERs) were calculated.


The Bone & Joint Journal
Vol. 106-B, Issue 4 | Pages 394 - 400
1 Apr 2024
Kjærvik C Gjertsen J Stensland E Dybvik EH Soereide O

Aims

The aims of this study were to assess quality of life after hip fractures, to characterize respondents to patient-reported outcome measures (PROMs), and to describe the recovery trajectory of hip fracture patients.

Methods

Data on 35,206 hip fractures (2014 to 2018; 67.2% female) in the Norwegian Hip Fracture Register were linked to data from the Norwegian Patient Registry and Statistics Norway. PROMs data were collected using the EuroQol five-dimension three-level questionnaire (EQ-5D-3L) scoring instrument and living patients were invited to respond at four, 12, and 36 months post fracture. Multiple imputation procedures were performed as a model to substitute missing PROM data. Differences in response rates between categories of covariates were analyzed using chi-squared test statistics. The association between patient and socioeconomic characteristics and the reported EQ-5D-3L scores was analyzed using linear regression.


The Bone & Joint Journal
Vol. 106-B, Issue 4 | Pages 401 - 411
1 Apr 2024
Carrothers A O'Leary R Hull P Chou D Alsousou J Queally J Bond SJ Costa ML

Aims

To assess the feasibility of a randomized controlled trial (RCT) that compares three treatments for acetabular fractures in older patients: surgical fixation, surgical fixation and hip arthroplasty (fix-and-replace), and non-surgical treatment.

Methods

Patients were recruited from seven UK NHS centres and randomized to a three-arm pilot trial if aged older than 60 years and had a displaced acetabular fracture. Feasibility outcomes included patients’ willingness to participate, clinicians’ capability to recruit, and dropout rates. The primary clinical outcome measure was the EuroQol five-dimension questionnaire (EQ-5D) at six months. Secondary outcomes were Oxford Hip Score, Disability Rating Index, blood loss, and radiological and mobility assessments.


The Bone & Joint Journal
Vol. 105-B, Issue 1 | Pages 72 - 81
1 Jan 2023
Stake IK Ræder BW Gregersen MG Molund M Wang J Madsen JE Husebye EE

Aims

The aim of this study was to compare the functional and radiological outcomes and the complication rate after nail and plate fixation of unstable fractures of the ankle in elderly patients.

Methods

In this multicentre study, 120 patients aged ≥ 60 years with an acute unstable AO/OTA type 44-B fracture of the ankle were randomized to fixation with either a nail or a plate and followed for 24 months after surgery. The primary outcome measure was the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot score. Secondary outcome measures were the Manchester-Oxford Foot Questionnaire, the Olerud and Molander Ankle score, the EuroQol five-dimension questionnaire, a visual analogue score for pain, complications, the quality of reduction of the fracture, nonunion, and the development of osteoarthritis.


The Bone & Joint Journal
Vol. 105-B, Issue 7 | Pages 801 - 807
1 Jul 2023
Dietrich G Terrier A Favre M Elmers J Stockton L Soppelsa D Cherix S Vauclair F

Aims

Tobacco, in addition to being one of the greatest public health threats facing our world, is believed to have deleterious effects on bone metabolism and especially on bone healing. It has been described in the literature that patients who smoke are approximately twice as likely to develop a nonunion following a non-specific bone fracture. For clavicle fractures, this risk is unclear, as is the impact that such a complication might have on the initial management of these fractures.

Methods

A systematic review and meta-analysis were performed for conservatively treated displaced midshaft clavicle fractures. Embase, PubMed, and Cochrane Central Register of Controlled Trials (via Cochrane Library) were searched from inception to 12 May 2022, with supplementary searches in Open Grey, ClinicalTrials.gov, ProQuest Dissertations & Theses, and Google Scholar. The searches were performed without limits for publication date or languages.


The Bone & Joint Journal
Vol. 106-B, Issue 1 | Pages 62 - 68
1 Jan 2024
Harris E Clement N MacLullich A Farrow L

Aims

Current levels of hip fracture morbidity contribute greatly to the overall burden on health and social care services. Given the anticipated ageing of the population over the coming decade, there is potential for this burden to increase further, although the exact scale of impact has not been identified in contemporary literature. We therefore set out to predict the future incidence of hip fracture and help inform appropriate service provision to maintain an adequate standard of care.

Methods

Historical data from the Scottish Hip Fracture Audit (2017 to 2021) were used to identify monthly incidence rates. Established time series forecasting techniques (Exponential Smoothing and Autoregressive Integrated Moving Average) were then used to predict the annual number of hip fractures from 2022 to 2029, including adjustment for predicted changes in national population demographics. Predicted differences in service-level outcomes (length of stay and discharge destination) were analyzed, including the associated financial cost of any changes.


The Bone & Joint Journal
Vol. 106-B, Issue 4 | Pages 412 - 418
1 Apr 2024
Alqarni AG Nightingale J Norrish A Gladman JRF Ollivere B

Aims

Frailty greatly increases the risk of adverse outcome of trauma in older people. Frailty detection tools appear to be unsuitable for use in traumatically injured older patients. We therefore aimed to develop a method for detecting frailty in older people sustaining trauma using routinely collected clinical data.

Methods

We analyzed prospectively collected registry data from 2,108 patients aged ≥ 65 years who were admitted to a single major trauma centre over five years (1 October 2015 to 31 July 2020). We divided the sample equally into two, creating derivation and validation samples. In the derivation sample, we performed univariate analyses followed by multivariate regression, starting with 27 clinical variables in the registry to predict Clinical Frailty Scale (CFS; range 1 to 9) scores. Bland-Altman analyses were performed in the validation cohort to evaluate any biases between the Nottingham Trauma Frailty Index (NTFI) and the CFS.


The Bone & Joint Journal
Vol. 106-B, Issue 7 | Pages 720 - 727
1 Jul 2024
Wu H Wang X Shen J Wei Z Wang S Xu T Luo F Xie Z

Aims

This study aimed to investigate the clinical characteristics and outcomes associated with culture-negative limb osteomyelitis patients.

Methods

A total of 1,047 limb osteomyelitis patients aged 18 years or older who underwent debridement and intraoperative culture at our clinic centre from 1 January 2011 to 31 December 2020 were included. Patient characteristics, infection eradication, and complications were analyzed between culture-negative and culture-positive cohorts.


Aims

The Peri-Implant and PeriProsthetic Survival AnalysiS (PIPPAS) study aimed to investigate the risk factors for one-year mortality of femoral peri-implant fractures (FPIFs).

Methods

This prospective, multicentre, observational study involved 440 FPIF patients with a minimum one-year follow-up. Data on demographics, clinical features, fracture characteristics, management, and mortality rates were collected and analyzed using both univariate and multivariate analyses. FPIF patients were elderly (median age 87 years (IQR 81 to 92)), mostly female (82.5%, n = 363), and frail: median clinical frailty scale 6 (IQR 4 to 7), median Pfeiffer 4 (1 to 7), median age-adjusted Charlson Comorbidity Index (CCI) 6 (IQR 5 to 7), and 58.9% (n = 250) were American Society of Anesthesiologists grade III.


The Bone & Joint Journal
Vol. 106-B, Issue 1 | Pages 77 - 85
1 Jan 2024
Foster AL Warren J Vallmuur K Jaiprakash A Crawford R Tetsworth K Schuetz MA

Aims

The aim of this study was to perform the first population-based description of the epidemiological and health economic burden of fracture-related infection (FRI).

Methods

This is a retrospective cohort study of operatively managed orthopaedic trauma patients from 1 January 2007 to 31 December 2016, performed in Queensland, Australia. Record linkage was used to develop a person-centric, population-based dataset incorporating routinely collected administrative, clinical, and health economic information. The FRI group consisted of patients with International Classification of Disease 10th Revision diagnosis codes for deep infection associated with an implanted device within two years following surgery, while all others were deemed not infected. Demographic and clinical variables, as well as healthcare utilization costs, were compared.


The Bone & Joint Journal
Vol. 106-B, Issue 6 | Pages 603 - 612
1 Jun 2024
Ahmad A Egeland EH Dybvik EH Gjertsen J Lie SA Fenstad AM Matre K Furnes O

Aims

This study aimed to compare mortality in trochanteric AO/OTA A1 and A2 fractures treated with an intramedullary nail (IMN) or sliding hip screw (SHS). The primary endpoint was 30-day mortality, with secondary endpoints at 0 to 1, 2 to 7, 8 to 30, 90, and 365 days.

Methods

We analyzed data from 26,393 patients with trochanteric AO/OTA A1 and A2 fractures treated with IMNs (n = 9,095) or SHSs (n = 17,298) in the Norwegian Hip Fracture Register (January 2008 to December 2020). Exclusions were made for patients aged < 60 years, pathological fractures, pre-2008 operations, contralateral hip fractures, fractures other than trochanteric A1/A2, and treatments other than IMNs or SHSs. Kaplan-Meier and Cox regression analyses adjusted for type of fracture, age, sex, cognitive impairment, American Society of Anesthesiologists (ASA) grade, and time period were conducted, along with calculations for number needed to harm (NNH).


Bone & Joint Open
Vol. 3, Issue 12 | Pages 953 - 959
23 Dec 2022
Raval P See A Singh HP

Aims

Distal third clavicle (DTC) fractures are increasing in incidence. Due to their instability and nonunion risk, they prove difficult to treat. Several different operative options for DTC fixation are reported but current evidence suggests variability in operative fixation. Given the lack of consensus, our objective was to determine the current epidemiological trends in DTC as well as their management within the UK.

Methods

A multicentre retrospective cohort collaborative study was conducted. All patients over the age of 18 with an isolated DTC fracture in 2019 were included. Demographic variables were recorded: age; sex; side of injury; mechanism of injury; modified Neer classification grading; operative technique; fracture union; complications; and subsequent procedures. Baseline characteristics were described for demographic variables. Categorical variables were expressed as frequencies and percentages.


Bone & Joint Research
Vol. 6, Issue 7 | Pages 423 - 432
1 Jul 2017
van der Stok J Hartholt KA Schoenmakers DAL Arts JJC

Objectives. The aim of this systematic literature review was to assess the clinical level of evidence of commercially available demineralised bone matrix (DBM) products for their use in trauma and orthopaedic related surgery. Methods. A total of 17 DBM products were used as search terms in two available databases: Embase and PubMed according to the Preferred Reporting Items for Systematic Reviews and Meta Analyses statement. All articles that reported the clinical use of a DBM-product in trauma and orthopaedic related surgery were included. Results. The literature search resulted in 823 manuscripts of which 64 manuscripts met the final inclusion criteria. The included manuscripts consisted of four randomised controlled trials (level I), eight cohort studies (level III) and 49 case-series (level IV). No clinical studies were found for ten DBM products, and most DBM products were only used in combination with other grafting materials. DBM products were most extensively investigated in spinal surgery, showing limited level I evidence that supports the use Grafton DBM (Osteotech, Eatontown, New Jersey) as a bone graft extender in posterolateral lumbar fusion surgery. DBM products are not thoroughly investigated in trauma surgery, showing mainly level IV evidence that supports the use of Allomatrix (Wright Medical, London, United Kingdom), DBX (DePuy Synthes, Zuchwil, Switzerland), Grafton DBM, or OrthoBlast (Citagenix Laval, Canada) as bone graft extenders. Conclusions. The clinical level of evidence that supports the use of DBM in trauma and orthopaedic surgery is limited and consists mainly of poor quality and retrospective case-series. More prospective, randomised controlled trials are needed to understand the clinical effect and impact of DBM in trauma and orthopaedic surgery. Cite this article: J. van der Stok, K. A. Hartholt, D. A. L. Schoenmakers, J. J. C. Arts. The available evidence on demineralised bone matrix in trauma and orthopaedic surgery: A systemati c review. Bone Joint Res 2017;6:423–432. DOI: 10.1302/2046-3758.67.BJR-2017-0027.R1


The Bone & Joint Journal
Vol. 104-B, Issue 8 | Pages 953 - 962
1 Aug 2022
Johnson NA Fairhurst C Brealey SD Cook E Stirling E Costa M Divall P Hodgson S Rangan A Dias JJ

Aims

There has been an increasing use of early operative fixation for scaphoid fractures, despite uncertain evidence. We conducted a meta-analysis to evaluate up-to-date evidence from randomized controlled trials (RCTs), comparing the effectiveness of the operative and nonoperative treatment of undisplaced and minimally displaced (≤ 2 mm displacement) scaphoid fractures.

Methods

A systematic review of seven databases was performed from the dates of their inception until the end of March 2021 to identify eligible RCTs. Reference lists of the included studies were screened. No language restrictions were applied. The primary outcome was the patient-reported outcome measure of wrist function at 12 months after injury. A meta-analysis was performed for function, pain, range of motion, grip strength, and union. Complications were reported narratively.


The Bone & Joint Journal
Vol. 104-B, Issue 11 | Pages 1266 - 1272
1 Nov 2022
Farrow L Brasnic L Martin C Ward K Adam K Hall AJ Clement ND MacLullich AMJ

Aims

The aim of this study was to examine perioperative blood transfusion practice, and associations with clinical outcomes, in a national cohort of hip fracture patients.

Methods

A retrospective cohort study was undertaken using linked data from the Scottish Hip Fracture Audit and the Scottish National Blood Transfusion Service between May 2016 and December 2020. All patients aged ≥ 50 years admitted to a Scottish hospital with a hip fracture were included. Assessment of the factors independently associated with red blood cell transfusion (RBCT) during admission was performed, alongside determination of the association between RBCT and hip fracture outcomes.


The Bone & Joint Journal
Vol. 104-B, Issue 11 | Pages 1256 - 1265
1 Nov 2022
Keene DJ Alsousou J Harrison P O’Connor HM Wagland S Dutton SJ Hulley P Lamb SE Willett K

Aims

To determine whether platelet-rich plasma (PRP) injection improves outcomes two years after acute Achilles tendon rupture.

Methods

A randomized multicentre two-arm parallel-group, participant- and assessor-blinded superiority trial was undertaken. Recruitment commenced on 28 July 2015 and two-year follow-up was completed in 21 October 2019. Participants were 230 adults aged 18 years and over, with acute Achilles tendon rupture managed with non-surgical treatment from 19 UK hospitals. Exclusions were insertion or musculotendinous junction injuries, major leg injury or deformity, diabetes, platelet or haematological disorder, medication with systemic corticosteroids, anticoagulation therapy treatment, and other contraindicating conditions. Participants were randomized via a central online system 1:1 to PRP or placebo injection. The main outcome measure was Achilles Tendon Rupture Score (ATRS) at two years via postal questionnaire. Other outcomes were pain, recovery goal attainment, and quality of life. Analysis was by intention-to-treat.


The Bone & Joint Journal
Vol. 104-B, Issue 6 | Pages 729 - 735
1 Jun 2022
Craxford S Marson BA Nightingale J Forward DP Taylor A Ollivere B

Aims

The last decade has seen a marked increase in surgical rib fracture fixation (SRF). The evidence to support this comes largely from retrospective cohorts, and adjusting for the effect of other injuries sustained at the same time is challenging. This study aims to assess the impact of SRF after blunt chest trauma using national prospective registry data, while controlling for other comorbidities and injuries.

Methods

A ten-year extract from the Trauma Audit and Research Network formed the study sample. Patients who underwent SRF were compared with those who received supportive care alone. The analysis was performed first for the entire eligible cohort, and then for patients with a serious (thoracic Abbreviated Injury Scale (AIS) ≥ 3) or minor (thoracic AIS < 3) chest injury without significant polytrauma. Multivariable logistic regression was performed to identify predictors of mortality. Kaplan-Meier estimators and multivariable Cox regression were performed to adjust for the effects of concomitant injuries and other comorbidities. Outcomes assessed were 30-day mortality, length of stay (LoS), and need for tracheostomy.


The Bone & Joint Journal
Vol. 104-B, Issue 5 | Pages 633 - 639
2 May 2022
Costa ML Achten J Parsons NR

Aims

The aim of this study was to report the outcomes of patients with severe open fractures of the lower limb in the five years after they took part in the Wound management for Open Lower Limb Fracture (WOLLF) trial.

Methods

The WOLLF trial compared standard dressings to negative pressure wound therapy (NPWT) applied at the end of the first surgical wound debridement, and patients were followed-up for 12 months. At 12 months, 170 of the original 460 participants agreed to take part in this medium-term follow-up study. Patients reported their Disability Rating Index (DRI) (0 to 100, where 100 is total disability) and health-related quality of life (HRQoL) using the EuroQol five-dimension three-level health questionnaire (EQ-5D-3L) annually by self-reported questionnaire. Further surgical interventions related to the open fracture were also recorded.


Aims

Our objective was to conduct a systematic review and meta-analysis, to establish whether differences arise in clinical outcomes between autologous and synthetic bone grafts in the operative management of tibial plateau fractures.

Methods

A structured search of MEDLINE, EMBASE, the online archives of Bone & Joint Publishing, and CENTRAL databases from inception until 28 July 2021 was performed. Randomized, controlled, clinical trials that compared autologous and synthetic bone grafts in tibial plateau fractures were included. Preclinical studies, clinical studies in paediatric patients, pathological fractures, fracture nonunion, or chondral defects were excluded. Outcome data were assessed using the Risk of Bias 2 (ROB2) framework and synthesized in random-effect meta-analysis. The Preferred Reported Items for Systematic Review and Meta-Analyses guidance was followed throughout.


The Bone & Joint Journal
Vol. 104-B, Issue 2 | Pages 274 - 282
1 Feb 2022
Grønhaug KML Dybvik E Matre K Östman B Gjertsen J

Aims

The aim of this study was to investigate if there are differences in outcome between sliding hip screws (SHSs) and intramedullary nails (IMNs) with regard to fracture stability.

Methods

We assessed data from 17,341 patients with trochanteric or subtrochanteric fractures treated with SHS or IMN in the Norwegian Hip Fracture Register from 2013 to 2019. Primary outcome measures were reoperations for stable fractures (AO Foundation/Orthopaedic Trauma Association (AO/OTA) type A1) and unstable fractures (AO/OTA type A2, A3, and subtrochanteric fractures). Secondary outcome measures were reoperations for A2, A3, and subtrochanteric fractures individually, one-year mortality, quality of life (EuroQol five-dimension three-level index score), pain (visual analogue scale (VAS)), and satisfaction (VAS) for stable and unstable fractures. Hazard rate ratios (HRRs) for reoperation were calculated using Cox regression analysis with adjustments for age, sex, and American Society of Anesthesiologists score.


The Bone & Joint Journal
Vol. 104-B, Issue 1 | Pages 127 - 133
1 Jan 2022
Viberg B Pedersen AB Kjærsgaard A Lauritsen J Overgaard S

Aims

The aim of this study was to assess the association of mortality and reoperation when comparing cemented and uncemented hemiarthroplasty (HA) in hip fracture patients aged over 65 years.

Methods

This was a population-based cohort study on hip fracture patients using prospectively gathered data from several national registries in Denmark from 2004 to 2015 with up to five years follow-up. The primary outcome was mortality and the secondary outcome was reoperation. Hazard ratios (HRs) for mortality and subdistributional hazard ratios (sHRs) for reoperations are shown with 95% confidence intervals (CIs).


Aims

This study sought to compare the rate of deep surgical site infection (SSI), as measured by the Centers for Disease Control and Prevention (CDC) definition, after surgery for a fracture of the hip between patients treated with standard dressings and those treated with incisional negative pressure wound therapy (iNPWT). Secondary objectives included determining the rate of recruitment and willingness to participate in the trial.

Methods

The study was a two-arm multicentre randomized controlled feasibility trial that was embedded in the World Hip Trauma Evaluation cohort study. Any patient aged > 65 years having surgery for hip fracture at five recruitment centres in the UK was considered to be eligible. They were randomly allocated to have either a standard dressing or iNPWT after closure of the wound. The primary outcome measure was deep SSI at 30 and 90 days, diagnosed according to the CDC criteria. Secondary outcomes were: rate of recruitment; further surgery within 120 days; health-related quality of life (HRQoL) using the EuroQol five-level five-dimension questionnaire (EQ-5D-5L); and related complications within 120 days as well as mobility and residential status at this time.


The Bone & Joint Journal
Vol. 103-B, Issue 7 | Pages 1317 - 1324
1 Jul 2021
Goubar A Martin FC Potter C Jones GD Sackley C Ayis S Sheehan KJ

Aims

The aim of this study to compare 30-day survival and recovery of mobility between patients mobilized early (on the day of, or day after surgery for a hip fracture) and patients mobilized late (two days or more after surgery), and to determine whether the presence of dementia influences the association between the timing of mobilization, 30-day survival, and recovery.

Methods

Analysis of the National Hip Fracture Database and hospital records for 126,897 patients aged ≥ 60 years who underwent surgery for a hip fracture in England and Wales between 2014 and 2016. Using logistic regression, we adjusted for covariates with a propensity score to estimate the association between the timing of mobilization, survival, and recovery of walking ability.


The Bone & Joint Journal
Vol. 103-B, Issue 6 | Pages 1033 - 1039
1 Jun 2021
Coughlin T Norrish AR Scammell BE Matthews PA Nightingale J Ollivere BJ

Aims

Following cast removal for nonoperatively treated distal radius fractures, rehabilitation facilitated by advice leaflet and advice video were compared to a course of face-to-face therapy.

Methods

Adults with an isolated, nonoperatively treated distal radius fracture were included at six weeks post-cast removal. Participants were randomized to delivery of rehabilitation interventions in one of three ways: an advice leaflet; an advice video; or face-to-face therapy session(s). The primary outcome measure was the Disabilities of the Arm, Shoulder and Hand (DASH) score at six weeks post intervention and secondary outcome measures included DASH at one year, DASH work subscale, grip strength, and range of motion at six weeks and one year.


Aims

We report the long-term outcomes of the UK Heel Fracture Trial (HeFT), a pragmatic, multicentre, two-arm, assessor-blinded, randomized controlled trial.

Methods

HeFT recruited 151 patients aged over 16 years with closed displaced, intra-articular fractures of the calcaneus. Patients with significant deformity causing fibular impingement, peripheral vascular disease, or other significant limb injuries were excluded. Participants were randomly allocated to open reduction and internal fixation (ORIF) or nonoperative treatment. We report Kerr-Atkins scores, self-reported difficulty walking and fitting shoes, and additional surgical procedures at 36, 48, and 60 months.


The Bone & Joint Journal
Vol. 103-B, Issue 2 | Pages 279 - 285
1 Feb 2021
Ferguson D Harwood P Allgar V Roy A Foster P Taylor M Moulder E Sharma H

Aims

Pin-site infection remains a significant problem for patients treated by external fixation. A randomized trial was undertaken to compare the weekly use of alcoholic chlorhexidine (CHX) for pin-site care with an emollient skin preparation in patients with a tibial fracture treated with a circular frame.

Methods

Patients were randomized to use either 0.5% CHX or Dermol (DML) 500 emollient pin-site care. A skin biopsy was taken from the tibia during surgery to measure the dermal and epidermal thickness and capillary, macrophage, and T-cell counts per high-powered field. The pH and hydration of the skin were measured preoperatively, at follow-up, and if pin-site infection occurred. Pin-site infection was defined using a validated clinical system.


The Bone & Joint Journal
Vol. 103-B, Issue 4 | Pages 762 - 768
1 Apr 2021
Ban I Kristensen MT Barfod KW Eschen J Kallemose T Troelsen A

Aims

To compare the functionality of adults with displaced mid-shaft clavicular fractures treated either operatively or nonoperatively and to compare the relative risk of nonunion and reoperation between the two groups.

Methods

Based on specific eligibility criteria, 120 adults (median age 37.5 years (interquartile range (18 to 61)) and 84% males (n = 101)) diagnosed with an acute displaced mid-shaft fracture were recruited, and randomized to either the operative (n = 60) or nonoperative (n = 60) treatment group. This randomized controlled, partially blinded trial followed patients for 12 months following initial treatment. Functionality was assessed by the Constant score (CS) (assessor blinded to treatment) and Disability of the Arm, Shoulder and Hand (DASH) score. Clinical and radiological evaluation, and review of patient files for complications and reoperations, were added as secondary outcomes.


The Bone & Joint Journal
Vol. 103-B, Issue 3 | Pages 449 - 455
1 Mar 2021
Viberg B Gundtoft PH Schønnemann JO Pedersen L Andersen LR Titlestad K Madsen CF Clemmensen SB Halekoh U Lauritsen J Overgaard S

Aims

To assess the safety of tranexamic acid (TXA) in a large cohort of patients aged over 65 years who have sustained a hip fracture, with a focus on transfusion rates, mortality, and thromboembolic events.

Methods

This is a consecutive cohort study with prospectively collected registry data. Patients with a hip fracture in the Region of Southern Denmark were included over a two-year time period (2015 to 2017) with the first year constituting a control group. In the second year, perioperative TXA was introduced as an intervention. Outcome was transfusion frequency, 30-day and 90-day mortality, and thromboembolic events. The latter was defined as any diagnosis or death due to arterial or venous thrombosis. The results are presented as relative risk (RR) and hazard ratio (HR) with 95% confidence intervals (CIs).


The Bone & Joint Journal
Vol. 102-B, Issue 12 | Pages 1723 - 1734
1 Dec 2020
Fung B Hoit G Schemitsch E Godbout C Nauth A

Aims

The purpose of this study was to: review the efficacy of the induced membrane technique (IMT), also known as the Masquelet technique; and investigate the relationship between patient factors and technique variations on the outcomes of the IMT.

Methods

A systematic search was performed in CINAHL, The Cochrane Library, Embase, Ovid MEDLINE, and PubMed. We included articles from 1 January 1980 to 30 September 2019. Studies with a minimum sample size of five cases, where the IMT was performed primarily in adult patients (≥ 18 years old), in a long bone were included. Multivariate regression models were performed on patient-level data to determine variables associated with nonunion, postoperative infection, and the need for additional procedures.


The Bone & Joint Journal
Vol. 103-B, Issue 2 | Pages 286 - 293
1 Feb 2021
Park CH Yan H Park J

Aims

No randomized comparative study has compared the extensile lateral approach (ELA) and sinus tarsi approach (STA) for Sanders type 2 calcaneal fractures. This randomized comparative study was conducted to confirm whether the STA was prone to fewer wound complications than the ELA.

Methods

Between August 2013 and August 2018, 64 patients with Sanders type 2 calcaneus fractures were randomly assigned to receive surgical treatment by the ELA (32 patients) and STA (32 patients). The primary outcome was development of wound complications. The secondary outcomes were postoperative complications, pain scored of a visual analogue scale (VAS), American Orthopaedic Foot and Ankle Society (AOFAS) score, 36-item Short Form health survey, operative duration, subtalar joint range of motion (ROM), Böhler’s angle and calcaneal width, and posterior facet reduction.


The Bone & Joint Journal
Vol. 102-B, Issue 7 | Pages 912 - 917
1 Jul 2020
Tahir M Chaudhry EA Zimri FK Ahmed N Shaikh SA Khan S Choudry UK Aziz A Jamali AR

Aims

It has been generally accepted that open fractures require early skeletal stabilization and soft-tissue reconstruction. Traditionally, a standard gauze dressing was applied to open wounds. There has been a recent shift in this paradigm towards negative pressure wound therapy (NPWT). The aim of this study was to compare the clinical outcomes in patients with open tibial fractures receiving standard dressing versus NPWT.

Methods

This multicentre randomized controlled trial was approved by the ethical review board of a public sector tertiary care institute. Wounds were graded using Gustilo-Anderson (GA) classification, and patients with GA-II to III-C were included in the study. To be eligible, the patient had to present within 72 hours of the injury. The primary outcome of the study was patient-reported Disability Rating Index (DRI) at 12 months. Secondary outcomes included quality of life assessment using 12-Item Short-Form Health Survey questionnaire (SF-12), wound infection rates at six weeks and nonunion rates at 12 months. Logistic regression analysis and independent-samples t-test were applied for secondary outcomes. Analyses of primary and secondary outcomes were performed using SPSS v. 22.0.1 and p-values of < 0.05 were considered significant.


Bone & Joint Open
Vol. 1, Issue 10 | Pages 644 - 653
14 Oct 2020
Kjærvik C Stensland E Byhring HS Gjertsen J Dybvik E Søreide O

Aims

The aim of this study was to describe variation in hip fracture treatment in Norway expressed as adherence to international and national evidence-based treatment guidelines, to study factors influencing deviation from guidelines, and to analyze consequences of non-adherence.

Methods

International and national guidelines were identified and treatment recommendations extracted. All 43 hospitals routinely treating hip fractures in Norway were characterized. From the Norwegian Hip Fracture Register (NHFR), hip fracture patients aged > 65 years and operated in the period January 2014 to December 2018 for fractures with conclusive treatment guidelines were included (n = 29,613: femoral neck fractures (n = 21,325), stable trochanteric fractures (n = 5,546), inter- and subtrochanteric fractures (n = 2,742)). Adherence to treatment recommendations and a composite indicator of best practice were analyzed. Patient survival and reoperations were evaluated for each recommendation.


The Bone & Joint Journal
Vol. 102-B, Issue 10 | Pages 1384 - 1391
3 Oct 2020
Yoo S Jang EJ Jo J Jo JG Nam S Kim H Lee H Ryu HG

Aims

Hospital case volume is shown to be associated with postoperative outcomes in various types of surgery. However, conflicting results of volume-outcome relationship have been reported in hip fracture surgery. This retrospective cohort study aimed to evaluate the association between hospital case volume and postoperative outcomes in patients who had hip fracture surgery. We hypothesized that higher case volume would be associated with lower risk of in-hospital and one-year mortality after hip fracture surgery.

Methods

Data for all patients who underwent surgery for hip fracture from January 2008 to December 2016 were extracted from the Korean National Healthcare Insurance Service database. According to mean annual case volume of surgery for hip fracture, hospitals were classified into very low (< 30 cases/year), low (30 to 50 cases/year), intermediate (50 to 100 cases/year), high (100 to 150 cases/year), or very high (> 150 cases/year) groups. The association between hospital case volume and in-hospital mortality or one-year mortality was assessed using the logistic regression model to adjust for age, sex, type of fracture, type of anaesthesia, transfusion, comorbidities, and year of surgery.


The Bone & Joint Journal
Vol. 102-B, Issue 1 | Pages 48 - 54
1 Jan 2020
Gwilym S Sansom L Rombach I Dutton SJ Achten J Costa ML

Aims

Distal radial fractures are the most common fracture sustained by the adult population. Most can be treated using cast immobilization without the need for surgery. The aim of this study was to assess the feasibility of a definitive trial comparing the commonly used fibreglass cast immobilization with an alternative product called Woodcast. Woodcast is a biodegradable casting material with theoretical benefits in terms of patient comfort as well as benefits to the environment.

Methods

This was a multicentre, two-arm, open-label, parallel-group randomized controlled feasibility trial. Patients with a fracture of the distal radius aged 16 years and over were recruited from four centres in the UK and randomized (1:1) to receive a Woodcast or fibreglass cast. Data were collected on participant recruitment and retention, clinical efficacy, safety, and patient acceptability.


The Bone & Joint Journal
Vol. 101-B, Issue 11 | Pages 1408 - 1415
1 Nov 2019
Hull PD Chou DTS Lewis S Carrothers AD Queally JM Allison A Barton G Costa ML

Aims

The aim of this study was to assess the feasibility of conducting a full-scale, appropriately powered, randomized controlled trial (RCT) comparing internal fracture fixation and distal femoral replacement (DFR) for distal femoral fractures in older patients.

Patients and Methods

Seven centres recruited patients into the study. Patients were eligible if they were greater than 65 years of age with a distal femoral fracture, and if the surgeon felt that they were suitable for either form of treatment. Outcome measures included the patients’ willingness to participate, clinicians’ willingness to recruit, rates of loss to follow-up, the ability to capture data, estimates of standard deviation to inform the sample size calculation, and the main determinants of cost. The primary clinical outcome measure was the EuroQol five-dimensional index (EQ-5D) at six months following injury.


The Bone & Joint Journal
Vol. 99-B, Issue 12 | Pages 1665 - 1676
1 Dec 2017
Stinton SB Graham PL Moloney NA Maclachlan LR Edgar DW Pappas E

Aims

To synthesise the literature and perform a meta-analysis detailing the longitudinal recovery in the first two years following a distal radius fracture (DRF) managed with volar plate fixation.

Materials and Methods

Three databases were searched to identify relevant articles. Following eligibility screening and quality assessment, data were extracted and outcomes were assimilated at the post-operative time points of interest. A state-of-the-art longitudinal mixed-effects meta-analysis model was employed to analyse the data.


The Bone & Joint Journal
Vol. 99-B, Issue 11 | Pages 1520 - 1525
1 Nov 2017
Haines N Kempton LB Seymour RB Bosse MJ Churchill C Hand K Hsu JR Keil D Kellam J Rozario N Sims S Karunakar MA

Aims

To evaluate the effect of a single early high-dose vitamin D supplement on fracture union in patients with hypovitaminosis D and a long bone fracture.

Patients and Methods

Between July 2011 and August 2013, 113 adults with a long bone fracture were enrolled in a prospective randomised double-blind placebo-controlled trial. Their serum vitamin D levels were measured and a total of 100 patients were found to be vitamin D deficient (< 20 ng/ml) or insufficient (< 30 ng/mL). These were then randomised to receive a single dose of vitamin D3 orally (100 000 IU) within two weeks of injury (treatment group, n = 50) or a placebo (control group, n = 50). We recorded patient demographics, fracture location and treatment, vitamin D level, time to fracture union and complications, including vitamin D toxicity.

Outcomes included union, nonunion or complication requiring an early, unplanned secondary procedure. Patients without an outcome at 15 months and no scheduled follow-up were considered lost to follow-up. The t-test and cross tabulations verified the adequacy of randomisation. An intention-to-treat analysis was carried out.


The Bone & Joint Journal
Vol. 99-B, Issue 11 | Pages 1526 - 1532
1 Nov 2017
Tarride JE Hopkins RB Blackhouse G Burke N Bhandari M Johal H Guyatt GH Busse JW

Aims

This 501-patient, multi-centre, randomised controlled trial sought to establish the effect of low-intensity, pulsed, ultrasound (LIPUS) on tibial shaft fractures managed with intramedullary nailing. We conducted an economic evaluation as part of this trial.

Patients and Methods

Data for patients’ use of post-operative healthcare resources and time taken to return to work were collected and costed using publicly available sources. Health-related quality of life, assessed using the Health Utilities Index Mark-3 (HUI-3), was used to derive quality-adjusted life years (QALYs). Costs and QALYs were compared between LIPUS and control (a placebo device) from a payer and societal perspective using non-parametric bootstrapping. All costs are reported in 2015 Canadian dollars unless otherwise stated.


The Bone & Joint Journal
Vol. 99-B, Issue 1_Supple_A | Pages 50 - 59
1 Jan 2017
Carli AV Negus JJ Haddad FS

Aims

Periprosthetic femoral fractures (PFF) following total hip arthroplasty (THA) are devastating complications that are associated with functional limitations and increased overall mortality. Although cementless implants have been associated with an increased risk of PFF, the precise contribution of implant geometry and design on the risk of both intra-operative and post-operative PFF remains poorly investigated. A systematic review was performed to aggregate all of the PFF literature with specific attention to the femoral implant used.

Patients and Methods

A systematic search strategy of several journal databases and recent proceedings from the American Academy of Orthopaedic Surgeons was performed. Clinical articles were included for analysis if sufficient implant description was provided. All articles were reviewed by two reviewers. A review of fundamental investigations of implant load-to-failure was performed, with the intent of identifying similar conclusions from the clinical and fundamental literature.


The Bone & Joint Journal
Vol. 98-B, Issue 8 | Pages 1119 - 1125
1 Aug 2016
Coughlin TA Ng JWG Rollins KE Forward DP Ollivere BJ

Aims

Flail chest from a blunt injury to the thorax is associated with significant morbidity and mortality. Its management globally is predominantly non-operative; however, there are an increasing number of centres which undertake surgical stabilisation. The aim of this meta-analysis was to compare the efficacy of this approach with that of non-operative management.

Patients and Methods

A systematic search of the literature was carried out to identify randomised controlled trials (RCTs) which compared the clinical outcome of patients with a traumatic flail chest treated by surgical stabilisation of any kind with that of non-operative management.


Bone & Joint Research
Vol. 5, Issue 10 | Pages 481 - 489
1 Oct 2016
Handoll HHG Brealey SD Jefferson L Keding A Brooksbank AJ Johnstone AJ Candal-Couto JJ Rangan A

Objectives

Accurate characterisation of fractures is essential in fracture management trials. However, this is often hampered by poor inter-observer agreement. This article describes the practicalities of defining the fracture population, based on the Neer classification, within a pragmatic multicentre randomised controlled trial in which surgical treatment was compared with non-surgical treatment in adults with displaced fractures of the proximal humerus involving the surgical neck.

Methods

The trial manual illustrated the Neer classification of proximal humeral fractures. However, in addition to surgical neck displacement, surgeons assessing patient eligibility reported on whether either or both of the tuberosities were involved. Anonymised electronic versions of baseline radiographs were sought for all 250 trial participants. A protocol, data collection tool and training presentation were developed and tested in a pilot study. These were then used in a formal assessment and classification of the trial fractures by two independent senior orthopaedic shoulder trauma surgeons.


The Bone & Joint Journal
Vol. 98-B, Issue 8 | Pages 1112 - 1118
1 Aug 2016
Pedersen AB Christiansen CF Gammelager H Kahlert J Sørensen HT

Aims

We examined risk of developing acute renal failure and the associated mortality among patients aged > 65 years undergoing surgery for a fracture of the hip.

Patients and Methods

We used medical databases to identify patients who underwent surgical treatment for a fracture of the hip in Northern Denmark between 2005 and 2011. Acute renal failure was classified as stage 1, 2 and 3 according to the Kidney Disease Improving Global Outcome criteria. We computed the risk of developing acute renal failure within five days after surgery with death as a competing risk, and the short-term (six to 30 days post-operatively) and long-term mortality (31 days to 365 days post-operatively). We calculated adjusted hazard ratios (HRs) for death with 95% confidence intervals (CIs).


The Bone & Joint Journal
Vol. 97-B, Issue 8 | Pages 1126 - 1131
1 Aug 2015
Nortunen S Flinkkilä T Lantto I Kortekangas T Niinimäki J Ohtonen P Pakarinen H

We prospectively assessed the diagnostic accuracy of the gravity stress test and clinical findings to evaluate the stability of the ankle mortise in patients with supination–external rotation-type fractures of the lateral malleolus without widening of the medial clear space. The cohort included 79 patients with a mean age of 44 years (16 to 82). Two surgeons assessed medial tenderness, swelling and ecchymosis and performed the external rotation (ER) stress test (a reference standard). A diagnostic radiographer performed the gravity stress test.

For the gravity stress test, the positive likelihood ratio (LR) was 5.80 with a 95% confidence interval (CI) of 2.75 to 12.27, and the negative LR was 0.15 (95% CI 0.07 to 0.35), suggesting a moderate change from the pre-test probability. Medial tenderness, both alone and in combination with swelling and/or ecchymosis, indicated a small change (positive LR, 2.74 to 3.25; negative LR, 0.38 to 0.47), whereas swelling and ecchymosis indicated only minimal changes (positive LR, 1.41 to 1.65; negative LR, 0.38 to 0.47).

In conclusion, when gravity stress test results are in agreement with clinical findings, the result is likely to predict stability of the ankle mortise with an accuracy equivalent to ER stress test results. When clinical examination suggests a medial-side injury, however, the gravity stress test may give a false negative result.

Cite this article: Bone Joint J 2015; 97-B:1126–31.


Bone & Joint Research
Vol. 3, Issue 12 | Pages 335 - 340
1 Dec 2014
Handoll HHG Goodchild L Brealey SD Hanchard NCA Jefferson L Keding A Rangan A

Objectives

A rigorous approach to developing, delivering and documenting rehabilitation within randomised controlled trials of surgical interventions is required to underpin the generation of reliable and usable evidence. This article describes the key processes used to ensure provision of good quality and comparable rehabilitation to all participants of a multi-centre randomised controlled trial comparing surgery with conservative treatment of proximal humeral fractures in adults.

Methods

These processes included the development of a patient information leaflet on self-care during sling immobilisation, the development of a basic treatment physiotherapy protocol that received input and endorsement by specialist physiotherapists providing patient care, and establishing an expectation for the provision of home exercises. Specially designed forms were also developed to facilitate reliable reporting of the physiotherapy care that patients received.