Advertisement for orthosearch.org.uk
Results 1 - 20 of 56
Results per page:
Bone & Joint Open
Vol. 3, Issue 3 | Pages 236 - 244
14 Mar 2022
Oliver WM Molyneux SG White TO Clement ND Duckworth AD

Aims. The primary aim of this study was to determine the rates of return to work (RTW) and sport (RTS) following a humeral shaft fracture. The secondary aim was to identify factors independently associated with failure to RTW or RTS. Methods. From 2008 to 2017, all patients with a humeral diaphyseal fracture were retrospectively identified. Patient demographics and injury characteristics were recorded. Details of pre-injury employment, sporting participation, and levels of return post-injury were obtained via postal questionnaire. The University of California, Los Angeles (UCLA) Activity Scale was used to quantify physical activity among active patients. Regression was used to determine factors independently associated with failure to RTW or RTS. Results. The Work Group comprised 177 patients in employment prior to injury (mean age 47 years (17 to 78); 51% female (n = 90)). Mean follow-up was 5.8 years (1.3 to 11). Overall, 85% (n = 151) returned to work at a mean of 14 weeks post-injury (0 to 104), but only 60% (n = 106) returned full-time to their previous employment. Proximal-third fractures (adjusted odds ratio (aOR) 4.0 (95% confidence interval (CI) 1.2 to 14.2); p = 0.029) were independently associated with failure to RTW. The Sport Group comprised 182 patients involved in sport prior to injury (mean age 52 years (18 to 85); 57% female (n = 104)). Mean follow-up was 5.4 years (1.3 to 11). The mean UCLA score reduced from 6.9 (95% CI 6.6 to 7.2) before injury to 6.1 (95% CI 5.8 to 6.4) post-injury (p < 0.001). There were 89% (n = 162) who returned to sport: 8% (n = 14) within three months, 34% (n = 62) within six months, and 70% (n = 127) within one year. Age ≥ 60 years was independently associated with failure to RTS (aOR 3.0 (95% CI 1.1 to 8.2); p = 0.036). No other factors were independently associated with failure to RTW or RTS. Conclusion. Most patients successfully return to work and sport following a humeral shaft fracture, albeit at a lower level of physical activity. Patients aged ≥ 60 yrs and those with proximal-third diaphyseal fractures are at increased risk of failing to return to activity. Cite this article: Bone Jt Open 2022;3(3):236–244


The Journal of Bone & Joint Surgery British Volume
Vol. 91-B, Issue 10 | Pages 1354 - 1359
1 Oct 2009
Giannoudis PV Nikolaou VS Kheir E Mehta S Stengel D Roberts CS

We investigated whether patients who underwent internal fixation for an isolated acetabular fracture were able to return to their previous sporting activities. We studied 52 consecutive patients with an isolated acetabular fracture who were operated on between January 2001 and December 2002. Their demographic details, fracture type, rehabilitation regime, outcome and complications were documented prospectively as was their level and frequency of participation in sport both before and after surgery. Quality of life was measured using the EuroQol-5D health outcome tool (EQ-5D). There was a significant reduction in level of activity, frequency of participation in sport (both p < 0.001) and EQ-5D scores in patients of all age groups compared to a normal English population (p = 0.001). A total of 22 (42%) were able to return to their previous level of activities: 35 (67%) were able to take part in sport at some level. Of all the parameters analysed, the Matta radiological follow-up criteria were the single best predictor for resumption of sporting activity and frequency of participation


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 66 - 66
1 Sep 2012
Vorlat P De Boeck H
Full Access

The reported results of compression fractures are poor. These results are not influenced by the severity of compression, the fracture site or the residual deformity. Otherwise, the factors that determine a patient's recovery are unknown. This study wants to identify the factors determining a patient's recovery after surgical treatment of compression fractures of the thoracolumbar spine. Therefore, in 31 surgically treated patients the pre-injury versus the 12-month follow-up differences in back pain, in global outcome and in participation were prospectively recorded. For this, the visual analogue scale for pain (VAS scale) and the Greenough and Fraser low back outcome scale were used. Of the latter scale, the 3 questions pertaining to participation were combined to create a participation subscale. For these differences and for time lost from work multiple linear regressions with combinations of 16 possible predictors were performed. At one year patients who smoke report a 25% less favorable global outcome and return 2.8 points (out of 10) less closely to their pre-injury pain level than patients who do not smoke. Patients with a fracture at the thoraco-lumbar junction return 3.3 points less closely to their pre-injury level on the VAS scale than those with a lumbar fracture. For each decrease in 1 of the 3 education levels, the patients stay away from work 15 weeks longer. Per degree of sagittal index at follow-up, patients stay 9 days longer at home. For each increase in level of occupation the return to the pre-injury participation level is 10% less favorable. The variability of time lost from work and of recovery of global outcome, pain and participation level explained by our models is 73%, 37%, 25% and 13% respectively. Smoking, localization of the fracture at the thoraco-lumbar junction and a high pre-existent level of occupation are strong negative predictors for recovery. A lower education level and sagittal fracture deformity at follow-up are negative predictors for sick leave but might also reflect the concerns of the physician when deciding about return to work


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 538 - 538
1 Sep 2012
Schuh R Hofstaetter J Bevoni R Krismer M Trnka H
Full Access

Introduction. End-stage ankle osteoarthritis is a debilitating condition that results in functional limitations and a poor quality of life. Ankle arthrodesis (AAD) and total ankle replacement (TAR) are the major surgical treatment options for ankle arthritis. The purpose of the present study was to compare preoperative and postoperative participation in sports and recreational activities, assesses levels of habitual physical activity, functional outcome and satisfaction of patients who underwent eighter AAD or TAR. Methods. 41 patients (mean age: 60.1y) underwent eighter AAD (21) or TAR (20) by a single surgeon. At an average follow-up of 30 (AAD) and 39 (TAR) months respectively activity levels were determined with use of the University of California at Los Angeles (UCLA) activity scale. The American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score, patients's satisfaction and pre- and postoperative participation in sports were assessed as well. Results. In the AAD group 90% and in the TAR group 76% were active in sports preoperatively. Postoperatively in both groups 76% were active in sports (AAD p=0.08). The UCLA score was 7.0 (± 1.9) in the AAD group and 6.8 (± 1.8) in the TAR group (p=0.78). The AOFAS score reached 75.6 (± 14) in the AAD group and 75.6 (± 16) in the TAR group (p=0.97). Conclusion. Our study revealed no significant difference between the groups concerning activity levels, participation in sports activities, UCLA and AOFAS score. After AAD the number of patients participating in sports decreased. However, this change was not statistically significant


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.


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.


Bone & Joint Open
Vol. 5, Issue 1 | Pages 46 - 52
19 Jan 2024
Assink N ten Duis K de Vries JPM Witjes MJH Kraeima J Doornberg JN IJpma FFA

Aims

Proper preoperative planning benefits fracture reduction, fixation, and stability in tibial plateau fracture surgery. We developed and clinically implemented a novel workflow for 3D surgical planning including patient-specific drilling guides in tibial plateau fracture surgery.

Methods

A prospective feasibility study was performed in which consecutive tibial plateau fracture patients were treated with 3D surgical planning, including patient-specific drilling guides applied to standard off-the-shelf plates. A postoperative CT scan was obtained to assess whether the screw directions, screw lengths, and plate position were performed according the preoperative planning. Quality of the fracture reduction was assessed by measuring residual intra-articular incongruence (maximum gap and step-off) and compared to a historical matched control group.


Bone & Joint Open
Vol. 3, Issue 7 | Pages 566 - 572
18 Jul 2022
Oliver WM Molyneux SG White TO Clement ND Duckworth AD

Aims

The primary aim was to estimate the cost-effectiveness of routine operative fixation for all patients with humeral shaft fractures. The secondary aim was to estimate the health economic implications of using a Radiographic Union Score for HUmeral fractures (RUSHU) of < 8 to facilitate selective fixation for patients at risk of nonunion.

Methods

From 2008 to 2017, 215 patients (mean age 57 yrs (17 to 18), 61% female (n = 130/215)) with a nonoperatively managed humeral diaphyseal fracture were retrospectively identified. Union was achieved in 77% (n = 165/215) after initial nonoperative management, with 23% (n = 50/215) uniting after surgery for nonunion. The EuroQol five-dimension three-level health index (EQ-5D-3L) was obtained via postal survey. Multiple regression was used to determine the independent influence of patient, injury, and management factors upon the EQ-5D-3L. An incremental cost-effectiveness ratio (ICER) of < £20,000 per quality-adjusted life-year (QALY) gained was considered cost-effective.


The Bone & Joint Journal
Vol. 103-B, Issue 10 | Pages 1627 - 1632
4 Oct 2021
Farrow L Hall AJ Ablett AD Johansen A Myint PK

Aims

The aim of this study was to determine the impact of hospital-level service characteristics on hip fracture outcomes and quality of care processes measures.

Methods

This was a retrospective analysis of publicly available audit data obtained from the National Hip Fracture Database (NHFD) 2018 benchmark summary and Facilities Survey. Data extraction was performed using a dedicated proforma to identify relevant hospital-level care process and outcome variables for inclusion. The primary outcome measure was adjusted 30-day mortality rate. A random forest-based multivariate imputation by chained equation (MICE) algorithm was used for missing value imputation. Univariable analysis for each hospital level factor was performed using a combination of Tobit regression, Siegal non-parametric linear regression, and Mann-Whitney U test analyses, dependent on the data type. In all analyses, a p-value < 0.05 denoted statistical significance.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 480 - 480
1 Sep 2012
Andersen K Christensen A Petersen M Christensen B Pedersen N Soballe K
Full Access

Background. Randomized, controlled trials (RCTs) are generally accepted as the “gold standard” for the provision of the most unbiased measures of the efficacy of interventions but are often criticized for the lack of external validity. We assessed the external validity of a RCT examining the efficacy of local infiltration analgesia (LIA) compared with continuous epidural infusion after total knee arthroplasty (TKA). Methods. During a one-year period, all patients consecutively admitted for elective, unilateral, primary TKA were identified as potential participants. All underwent eligibility screening to determine who were eligible for participation in a randomized controlled trial. We investigated the distribution of preoperative characteristics and postoperative variables among excluded patients, non-consenters, and enrolled and randomized participants. Results. In all 157 patients were identified as potential participants. Only 49 patients (31%) were enrolled and randomized. A significant difference was found in both preoperative characteristics and clinical outcome variables. Non-participants were less healthy and needed more help from the home care service than did participants. Furthermore, they were hospitalized longer. Interpretation. Our findings demonstrate the importance of reporting the results of RCTs in a way that allows clinicians to judge to whom the results can reasonably be applied


Bone & Joint Open
Vol. 2, Issue 12 | Pages 1027 - 1034
1 Dec 2021
Hassellund S Zolic-Karlsson Z Williksen JH Husby T Madsen JE Frihagen F

Aims

The purpose was to compare operative treatment with a volar plate and nonoperative treatment of displaced distal radius fractures in patients aged 65 years and over in a cost-effectiveness analysis.

Methods

A cost-utility analysis was performed alongside a randomized controlled trial. A total of 50 patients were randomized to each group. We prospectively collected data on resource use during the first year post-fracture, and estimated costs of initial treatment, further operations, physiotherapy, home nursing, and production loss. Health-related quality of life was based on the Euro-QoL five-dimension, five-level (EQ-5D-5L) utility index, and quality-adjusted life-years (QALYs) were calculated.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 331 - 331
1 Sep 2012
Mariathas C Williams G Pattison G Lazar J Rashied M
Full Access

Introduction. No previous studies have attempted to measure parental satisfaction and service quality in regards to paediatric orthopaedic service inpatient care. We performed a prospective observational study to assess parental satisfaction with the level of service provided for paediatric orthopaedic inpatient care in our unit. Methods. We employed the validated Swedish parent satisfaction questionnaire to generate parental satisfaction data from 104 paediatric orthopaedic hospital inpatients between August 2009 and May 2010 (49 elective and 55 trauma paediatric orthopaedic admissions, median age range 2–6 years). Questions focused on eight domains of quality: Information on illness, information on routines, accessibility, medical treatment, care processes, staff attitudes, parent participation and staff work environment. Scores generated were a percentage of the maximum achievable for that quality index, for example 100% would correspond to a parent awarding all questions for that index the highest possible score. Results. Overall combined scores for the care indices were highest for parent's perception of ‘medical treatment’ (95%) and ‘staff attitudes’ (95%). The medical treatment index includes questions regarding staff member's skill and competence. Lowest scores corresponded to the index' information routines' (86%). Conclusion. Information routines applies to parental awareness of ward rounds, to whom questions should be directed and which doctors/nursing staff are responsible for their child's care. Lower scores in relation to this index were substantiated by comments from relatives requesting greater information provision. The types of information parents required was routinely provided suggesting that retention rather than lack of information is the main issue. Provision of information pamphlets tailored to common injuries or elective procedures might prove an effective method for improving this aspect of care and increasing overall parental satisfaction with paediatric orthopaedic inpatient service


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 179 - 179
1 Sep 2012
Ilchmann T Pannhorst S Mertens A Clauss M
Full Access

Introduction. The usefulness of minimal invasive hip replacement is frequently discussed but there is a lack of data on the effect of the surgical approach on early results. We wanted to study the effect of the surgical approach on the peri- and early postoperative outcome. Material/Methods. In a prospective case control study 315 elective hip replacements were performed between January 2008 and March 2010. Until March 2009 a lateral transgluteal approach (STD) was used, then the approach was changed to a minimal invasive anterior approach (MIS). All operations were performed in the same routine setting not affected by the approach. Duration of operation, complications and bloodloss were assessed. 1 week postoperatively, independent mobility, stairs, central analgetics were analysed and length of stay was recorded. At 6 and 12 weeks, pain and patients satisfaction (VAS) and the Harris Hip Score were assessed. Pre- and postoperative radiographs were compared for component position and orientation (EBRA). Results. 6 patients (hips) refused participation, 4 were excluded for other reasons. 174 (57%) hips belonged to STD and 131 (43%) to MIS. There were no demographic differences between both groups. Operation time was longer for MIS (109 vs. 123 min, p=.001). At 1 week, MIS patients were more mobile (rising up from bed, p=.009; stairs, p=.015) and time of hospitalisation became shorter (p=.001). At 6 weeks, MIS patients had less pain at motion (p=.013), less limb (p=.001), a higher HHS (p=.007) and were more satisfied (p=.046). The differences remained unchanged after 12 weeks. There was no difference in implant positioning between the groups. Inclination was higher in group MIS [39° (SD 6°) vs. 38° (SD 7°), p=.030], anteversion was lower [21° (SD 8°) vs. 24° (SD 8°), p=.010]. Conclusion. The introduction of the MIS anterior approach was safe. Early rehabilitation was facilitated and clinical results were better. Radiographical results were not impaired by the new approach. We see no disadvantage of the MIS anterior approach. Adaptions in the clinical setup might further facilitate rehabilitation


The Bone & Joint Journal
Vol. 103-B, Issue 4 | Pages 746 - 754
1 Apr 2021
Schnetzke M El Barbari J Schüler S Swartman B Keil H Vetter S Gruetzner PA Franke J

Aims

Complex joint fractures of the lower extremity are often accompanied by soft-tissue swelling and are associated with prolonged hospitalization and soft-tissue complications. The aim of the study was to evaluate the effect of vascular impulse technology (VIT) on soft-tissue conditioning in comparison with conventional elevation.

Methods

A total of 100 patients were included in this prospective, randomized, controlled monocentre study allocated to the three subgroups of dislocated ankle fracture (n = 40), pilon fracture (n = 20), and intra-articular calcaneal fracture (n = 40). Patients were randomized to the two study groups in a 1:1 ratio. The effectiveness of VIT (intervention) compared with elevation (control) was analyzed separately for the whole study population and for the three subgroups. The primary endpoint was the time from admission until operability (in days).


The Journal of Bone & Joint Surgery British Volume
Vol. 79-B, Issue 2 | Pages 280 - 284
1 Mar 1997
van Dijk CN Verhagen RAW Tol JL

From 1990 to 1994 we undertook arthroscopy of the ankle on 34 consecutive patients with residual complaints following fracture. Two groups were compared prospectively. Group I comprised 18 patients with complaints which could be attributed clinically to anterior bony or soft-tissue impingement. In group II the complaints of the 16 patients were more diffuse and despite extensive investigation the definitive diagnosis was not clear before arthroscopy. At the time of the fracture, some osteophytes were already present in 41% of the patients. These were related to previous supination trauma and participation in soccer. Arthroscopic treatment consisted of removal of the anteriorly located osteophytes and/or scar tissue. After two years, group I showed a significantly better score for patient satisfaction (p = 0.02). There were good or excellent results in group I in 76% and group II in 43%. Patients with residual complaints after an ankle fracture and clinical signs of anterior impingement may benefit from arthroscopic surgery. The place for diagnostic ankle arthroscopy is limited


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 193 - 193
1 Sep 2012
Lipperts M Grimm B Van Asten W Senden R Van Laarhoven S Heyligers I
Full Access

Introduction. In orthopaedics, clinical outcome assessment (COA) is still mostly performed by questionnaires which suffer from subjectivity, a ceiling effect and pain dominance. Real life activity monitoring (AM) holds the promise to become the new standard in COA with small light weight and easy to use accelerometers. More and more activities can be identified by algorithms based on accelerometry. The identification of stair climbing for instance is important to assess the participation of patients in normal life after an orthopaedic procedure. In this study we validated a custom made algorithm to distinguish normal gait, ascending and descending stairs on a step by step basis. Methods. A small, lightweight 3D-accelerometer taped to the lateral side of the affected (patients) or non-dominant (healthy subjects) upper leg served as the activity monitor. 13 Subjects (9 patients, 4 healthy) walked a few steps before descending a flight stairs (20 steps with a 180o turn in the middle), walked some steps more, turned around and ascended the same stairs. Templates (up, down and level) were obtained by averaging and stretching the vertical acceleration in the 4 healthy subjects. Classification parameters (low pass (0.4 Hz) horizontal (front-back) acceleration and the Euclidian distance between the vertical acceleration and each template) were obtained for each step. Accuracy is given by the percentage of correctly classified steps. Results. In total the subjects took 537 (41+/-8 mean+/-std) steps, 525 of which were correctly identified as step. 12 Steps were not detected, and 2 steps were incorrectly identified as step. Per subject the accuracy of the classification algorithm ranged from 57% to 97%. In only 2 subjects the accuracy was less than 75%, giving an overall accuracy of 85%. Discussion. In literature algorithms able to identify walking the stairs and normal walking have been reported with an accuracy in the range of 80–95%1,2. Our algorithm falls well within this range, and can be even further improved. The low accuracy in two subjects can be explained by the fact that the sensor was placed more to the front of the leg, which influences the low-pass horizontal acceleration. Using a combination of front-back and left-right acceleration could possibly solve this problem. In the future we are confident to identify also other activities and even distinguish different types of stair climbing (i.e. taking a step with each leg versus only taking steps with the unaffected leg and ‘dragging’ the second leg) and obtain more specific activity profiles to be used in clinical outcome assessment


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.


Bone & Joint Open
Vol. 2, Issue 2 | Pages 72 - 78
1 Feb 2021
Agni NR Costa ML Achten J O’Connor H Png ME Peckham N Dutton SJ Wallis S Milca S Reed M

Aims

Patients receiving cemented hemiarthroplasties after hip fracture have a significant risk of deep surgical site infection (SSI). Standard UK practice to minimize the risk of SSI includes the use of antibiotic-loaded bone cement with no consensus regarding type, dose, or antibiotic content of the cement. This is the protocol for a randomized clinical trial to investigate the clinical and cost-effectiveness of high dose dual antibiotic-loaded cement in comparison to low dose single antibiotic-loaded cement in patients 60 years and over receiving a cemented hemiarthroplasty for an intracapsular hip fracture.

Methods

The WHiTE 8 Copal Or Palacos Antibiotic Loaded bone cement trial (WHiTE 8 COPAL) is a multicentre, multi-surgeon, parallel, two-arm, randomized clinical trial. The pragmatic study will be embedded in the World Hip Trauma Evaluation (WHiTE) (ISRCTN 63982700). Participants, including those that lack capacity, will be allocated on a 1:1 basis stratified by recruitment centre to either a low dose single antibiotic-loaded bone cement or a high dose dual antibiotic-loaded bone cement. The primary analysis will compare the differences in deep SSI rate as defined by the Centers for Disease Control and Prevention within 90 days of surgery via medical record review and patient self-reported questionnaires. Secondary outcomes include UK Core Outcome Set for hip fractures, complications, rate of antibiotic prescription, resistance patterns of deep SSI, and resource use (more specifically, cost-effectiveness) up to four months post-randomization. A minimum of 4,920 patients will be recruited to obtain 90% power to detect an absolute difference of 1.5% in the rate of deep SSI at 90 days for the expected 3% deep SSI rate in the control group.