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Bone & Joint Research
Vol. 10, Issue 1 | Pages 41 - 50
1 Jan 2021
Wong RMY Choy VMH Li J Li TK Chim YN Li MCM Cheng JCY Leung K Chow SK Cheung WH

Aims. Fibrinolysis plays a key transition step from haematoma formation to angiogenesis and fracture healing. Low-magnitude high-frequency vibration (LMHFV) is a non-invasive biophysical modality proven to enhance fibrinolytic factors. This study investigates the effect of LMHFV on fibrinolysis in a clinically relevant animal model to accelerate osteoporotic fracture healing. Methods. A total of 144 rats were randomized to four groups: sham control; sham and LMHFV; ovariectomized (OVX); and ovariectomized and LMHFV (OVX-VT). Fibrinolytic potential was evaluated by quantifying fibrin, tissue plasminogen activator (tPA), and plasminogen activator inhibitor-1 (PAI-1) along with healing outcomes at three days, one week, two weeks, and six weeks post-fracture. Results. All rats achieved healing, and x-ray relative radiopacity for OVX-VT was significantly higher compared to OVX at week 2. Martius Scarlet Blue (MSB) staining revealed a significant decrease of fibrin content in the callus in OVX-VT compared with OVX on day 3 (p = 0.020). Mean tPA from muscle was significantly higher for OVX-VT compared to OVX (p = 0.020) on day 3. Mechanical testing revealed the mean energy to failure was significantly higher for OVX-VT at 37.6 N mm (SD 8.4) and 71.9 N mm (SD 30.7) compared with OVX at 5.76 N mm (SD 7.1) (p = 0.010) and 17.7 N mm (SD 11.5) (p = 0.030) at week 2 and week 6, respectively. Conclusion. Metaphyseal fracture healing is enhanced by LMHFV, and one of the important molecular pathways it acts on is fibrinolysis. LMHFV is a promising intervention for osteoporotic metaphyseal fracture healing. The improved mechanical properties, acceleration of fracture healing, and safety justify its role into translation to future clinical studies. Cite this article: Bone Joint Res 2021;10(1):41–50


The Bone & Joint Journal
Vol. 102-B, Issue 5 | Pages 618 - 626
1 May 2020
Zhou W Sankar WN Zhang F Li L Zhang L Zhao Q

Aims. The goal of closed reduction (CR) in the treatment of developmental dysplasia of the hip (DDH) is to achieve and maintain concentricity of the femoral head in the acetabulum. However, concentric reduction is not immediately attainable in all hips and it remains controversial to what degree a non-concentric reduction is acceptable. This prospective study is aimed at investigating the dynamic evolution of the hip joint space after CR in DDH using MRI. Methods. A consecutive series of patients with DDH who underwent CR since March 2014 were studied. Once the safety and stability were deemed adequate intraoperatively, reduction was accepted regardless of concentricity. Concentricity was defined when the superior joint space (SJS) and medial joint space (MJS) were both less than 2 mm, based on MRI. A total of 30 children, six boys and 24 girls, involving 35 hips, were recruited for the study. The mean age at CR was 13.7 months (3.5 to 27.6) and the mean follow-up was 49.5 months (approximately four years) (37 to 60). The joint space was evaluated along with the interval between the inverted and everted limbus. Results. Only three hips (8.6%) were fully concentric immediately after CR. During follow-up, 24 hips (68.6%) and 27 hips (77.1%) became concentric at six months and one year, respectively. Immediate SJS after CR decreased from 3.51 mm to 0.79 mm at six months follow-up (p = 0.001). SJS in the inverted group decreased from 3.75 mm to 0.97 mm at six months follow-up. SJS or MJS in the everted group were less than those in the inverted group at each time of follow-up (p = 0.008, p = 0.002). Conclusion. A stable, safe but non-concentric reduction achieved before the age of two years appears to improve over time with nearly 80% of hips becoming fully concentric by one year. Cite this article: Bone Joint J 2020;102-B(5):618–626


The Bone & Joint Journal
Vol. 106-B, Issue 4 | Pages 303 - 306
1 Apr 2024
Staats K Kayani B Haddad FS


The Bone & Joint Journal
Vol. 106-B, Issue 10 | Pages 1039 - 1043
1 Oct 2024
Luo TD Kayani B Magan A Haddad FS

The subject of noise in the operating theatre was recognized as early as 1972 and has been compared to noise levels on a busy highway. While noise-induced hearing loss in orthopaedic surgery specifically has been recognized as early as the 1990s, it remains poorly studied. As a result, there has been renewed focus in this occupational hazard. Noise level is typically measured in decibels (dB), whereas noise adjusted for human perception uses A-weighted sound levels and is expressed in dBA. Mean operating theatre noise levels range between 51 and 75 dBA, with peak levels between 80 and 119 dBA. The greatest sources of noise emanate from powered surgical instruments, which can exceed levels as high as 140 dBA. Newer technology, such as robotic-assisted systems, contribute a potential new source of noise. This article is a narrative review of the deleterious effects of prolonged noise exposure, including noise-induced hearing loss in the operating theatre team and the patient, intraoperative miscommunication, and increased cognitive load and stress, all of which impact the surgical team’s overall performance. Interventions to mitigate the effects of noise exposure include the use of quieter surgical equipment, the implementation of sound-absorbing personal protective equipment, or changes in communication protocols. Future research endeavours should use advanced research methods and embrace technological innovations to proactively mitigate the effects of operating theatre noise.

Cite this article: Bone Joint J 2024;106-B(10):1039–1043.


Bone & Joint Open
Vol. 5, Issue 3 | Pages 162 - 173
4 Mar 2024
Di Mascio L Hamborg T Mihaylova B Kassam J Shah B Stuart B Griffin XL

Aims

Is it feasible to conduct a definitive multicentre trial in community settings of corticosteroid injections (CSI) and hydrodilation (HD) compared to CSI for patients with frozen shoulder? An adequately powered definitive randomized controlled trial (RCT) delivered in primary care will inform clinicians and the public whether hydrodilation is a clinically and cost-effective intervention. In this study, prior to a full RCT, we propose a feasibility trial to evaluate recruitment and retention by patient and clinician willingness of randomization; rates of withdrawal, crossover and attrition; and feasibility of outcome data collection from routine primary and secondary care data.

Methods

In the UK, the National Institute for Health and Care Excellence (NICE) advises that prompt early management of frozen shoulder is initiated in primary care settings with analgesia, physiotherapy, and joint injections; most people can be managed without an operation. Currently, there is variation in the type of joint injection: 1) CSI, thought to reduce the inflammation of the capsule reducing pain; and 2) HD, where a small volume of fluid is injected into the shoulder joint along with the steroid, aiming to stretch the capsule of the shoulder to improve pain, but also allowing greater movement. The creation of musculoskeletal hubs nationwide provides infrastructure for the early and effective management of frozen shoulder. This potentially reduces costs to individuals and the wider NHS perhaps negating the need for a secondary care referral.


The Bone & Joint Journal
Vol. 97-B, Issue 4 | Pages 434 - 441
1 Apr 2015
Shabani F Farrier AJ Krishnaiyan R Hunt C Uzoigwe CE Venkatesan M

Drug therapy forms an integral part of the management of many orthopaedic conditions. However, many medicines can produce serious adverse reactions if prescribed inappropriately, either alone or in combination with other drugs. Often these hazards are not appreciated. In response to this, the European Union recently issued legislation regarding safety measures which member states must adopt to minimise the risk of errors of medication. . In March 2014 the Medicines and Healthcare products Regulatory Agency and NHS England released a Patient Safety Alert initiative focussed on errors of medication. There have been similar initiatives in the United States under the auspices of The National Coordinating Council for Medication Error and The Joint Commission on the Accreditation of Healthcare Organizations. These initiatives have highlighted the importance of informing and educating clinicians. Here, we discuss common drug interactions and contra-indications in orthopaedic practice. This is germane to safe and effective clinical care. Cite this article: Bone Joint J 2015;97-B:434–41


Objectives. Tranexamic acid (TXA) is an antifibrinolytic agent used as a blood-sparing technique in total knee arthroplasty (TKA), and is routinely administered by intravenous (IV) or intra-articular (IA) injection. Recently, a novel method of TXA administration, the combined IV and IA application of TXA, has been applied in TKA. However, the scientific evidence of combined administration of TXA in TKA is still meagre. This meta-analysis aimed to investigate the efficacy and safety of combined IV and IA TXA in patients undergoing TKA. Materials and Methods. A systematic search was carried out in PubMed, the Cochrane Clinical Trial Register (Issue12 2015), Embase, Web of Science and the Chinese Biomedical Database. Only randomised controlled trials (RCT) evaluating the efficacy and safety of combined use TXA in TKA were identified. Two authors independently identified the eligible studies, extracted data and assessed the methodological quality of included studies. Meta-analysis was conducted using Review Manager 5.3 software. Results. A total of ten RCTs (1143 patients) were included in this study. All the included studies were randomised and the quality of included studies still needed improvement. The results indicated that, compared with either placebo or the single-dose TXA (IV or IA) group, the combination of IV and IA TXA group had significantly less total blood loss, hidden blood loss, total drain output, a lower transfusion rate and a lower drop in haemoglobin level. There were no statistically significant differences in complications such as wound infection and deep vein thrombosis between the combination group and the placebo or single-dose TXA group. Conclusions. Compared with placebo or the single-dose TXA, the combined use of IV and IA TXA provided significantly better results with respect to all outcomes related to post-operative blood loss without increasing the risk of thromboembolic complications in TKA. Cite this article: Z. F. Yuan, H. Yin, W. P. Ma, D. L. Xing. The combined effect of administration of intravenous and topical tranexamic acid on blood loss and transfusion rate in total knee arthroplasty: combined tranexamic acid for TKA. Bone Joint Res 2016;5:353–361. DOI: 10.1302/2046-3758.58.BJR-2016-0001.R2


Bone & Joint Research
Vol. 12, Issue 1 | Pages 5 - 8
1 Jan 2023
Im G

Cite this article: Bone Joint Res 2023;12(1):5–8.


The Bone & Joint Journal
Vol. 101-B, Issue 8 | Pages 922 - 928
1 Aug 2019
Garner A van Arkel RJ Cobb J

Aims. There has been a recent resurgence in interest in combined partial knee arthroplasty (PKA) as an alternative to total knee arthroplasty (TKA). The varied terminology used to describe these procedures leads to confusion and ambiguity in communication between surgeons, allied health professionals, and patients. A standardized classification system is required for patient safety, accurate clinical record-keeping, clear communication, correct coding for appropriate remuneration, and joint registry data collection. Materials and Methods. An advanced PubMed search was conducted, using medical subject headings (MeSH) to identify terms and abbreviations used to describe knee arthroplasty procedures. The search related to TKA, unicompartmental (UKA), patellofemoral (PFA), and combined PKA procedures. Surveys were conducted of orthopaedic surgeons, trainees, and biomechanical engineers, who were asked which of the descriptive terms and abbreviations identified from the literature search they found most intuitive and appropriate to describe each procedure. The results were used to determine a popular consensus. Results. Survey participants preferred “bi-unicondylar arthroplasty” (Bi-UKA) to describe ipsilateral medial and lateral unicompartmental arthroplasty; “medial bi-compartmental arthroplasty” (BCA-M) to describe ipsilateral medial unicompartmental arthroplasty with patellofemoral arthroplasty; “lateral bi-compartmental arthroplasty” (BCA-L) to describe ipsilateral lateral unicompartmental arthroplasty with patellofemoral arthroplasty; and tri-compartmental arthroplasty (TCA) to describe ipsilateral patellofemoral and medial and lateral unicompartmental arthroplasties. “Combined partial knee arthroplasty” (CPKA) was the favoured umbrella term. Conclusion. We recommend bi-unicondylar arthroplasty (Bi-UKA), medial bicompartmental arthroplasty (BCA-M), lateral bicompartmental arthroplasty (BCA-L), and tricompartmental arthroplasty (TCA) as the preferred terms to classify CPKA procedures. Cite this article: Bone Joint J 2019;101-B:922–928


Bone & Joint Open
Vol. 5, Issue 6 | Pages 464 - 478
3 Jun 2024
Boon A Barnett E Culliford L Evans R Frost J Hansen-Kaku Z Hollingworth W Johnson E Judge A Marques EMR Metcalfe A Navvuga P Petrie MJ Pike K Wylde V Whitehouse MR Blom AW Matharu GS

Aims

During total knee replacement (TKR), surgeons can choose whether or not to resurface the patella, with advantages and disadvantages of each approach. Recently, the National Institute for Health and Care Excellence (NICE) recommended always resurfacing the patella, rather than never doing so. NICE found insufficient evidence on selective resurfacing (surgeon’s decision based on intraoperative findings and symptoms) to make recommendations. If effective, selective resurfacing could result in optimal individualized patient care. This protocol describes a randomized controlled trial to evaluate the clinical and cost-effectiveness of primary TKR with always patellar resurfacing compared to selective patellar resurfacing.

Methods

The PAtellar Resurfacing Trial (PART) is a patient- and assessor-blinded multicentre, pragmatic parallel two-arm randomized superiority trial of adults undergoing elective primary TKR for primary osteoarthritis at NHS hospitals in England, with an embedded internal pilot phase (ISRCTN 33276681). Participants will be randomly allocated intraoperatively on a 1:1 basis (stratified by centre and implant type (cruciate-retaining vs cruciate-sacrificing)) to always resurface or selectively resurface the patella, once the surgeon has confirmed sufficient patellar thickness for resurfacing and that constrained implants are not required. The primary analysis will compare the Oxford Knee Score (OKS) one year after surgery. Secondary outcomes include patient-reported outcome measures at three months, six months, and one year (Knee injury and Osteoarthritis Outcome Score, OKS, EuroQol five-dimension five-level questionnaire, patient satisfaction, postoperative complications, need for further surgery, resource use, and costs). Cost-effectiveness will be measured for the lifetime of the patient. Overall, 530 patients will be recruited to obtain 90% power to detect a four-point difference in OKS between the groups one year after surgery, assuming up to 40% resurfacing in the selective group.


The Bone & Joint Journal
Vol. 105-B, Issue 4 | Pages 356 - 360
15 Mar 2023
Baker PN Jeyapalan R Jameson SS

The importance of registries has been brought into focus by recent UK national reports focusing on implant (Cumberlege) and surgeon (Paterson) performance. National arthroplasty registries provide real-time, real-world information about implant, hospital, and surgeon performance and allow case identification in the event of product recall or adverse surgical outcomes. They are a valuable resource for research and service improvement given the volume of data recorded and the longitunidal nature of data collection. This review discusses the current value of registry data as it relates to both clinical practice and research.

Cite this article: Bone Joint J 2023;105-B(4):356–360.


The Bone & Joint Journal
Vol. 97-B, Issue 11 | Pages 1555 - 1561
1 Nov 2015
Kwan MK Chiu CK Lee CK Chan CYW

Percutaneous placement of pedicle screws is a well-established technique, however, no studies have compared percutaneous and open placement of screws in the thoracic spine. The aim of this cadaveric study was to compare the accuracy and safety of these techniques at the thoracic spinal level. A total of 288 screws were inserted in 16 (eight cadavers, 144 screws in percutaneous and eight cadavers, 144 screws in open). Pedicle perforations and fractures were documented subsequent to wide laminectomy followed by skeletalisation of the vertebrae. The perforations were classified as grade 0: no perforation, grade 1: < 2 mm perforation, grade 2: 2 mm to 4 mm perforation and grade 3: > 4 mm perforation. In the percutaneous group, the perforation rate was 11.1% with 15 (10.4%) grade 1 and one (0.7%) grade 2 perforations. In the open group, the perforation rate was 8.3% (12 screws) and all were grade 1. This difference was not significant (p = 0.45). There were 19 (13.2%) pedicle fractures in the percutaneous group and 21 (14.6%) in the open group (p = 0.73). In summary, the safety of percutaneous fluoroscopy-guided pedicle screw placement in the thoracic spine between T4 and T12 is similar to that of the conventional open technique. Cite this article: Bone Joint J 2015;97-B:1555–61


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. 102-B, Issue 10 | Pages 1297 - 1302
3 Oct 2020
Kurosaka K Tsukada S Ogawa H Nishino M Nakayama T Yoshiya S Hirasawa N

Aims. Although periarticular injection plays an important role in multimodal pain management following total hip arthroplasty (THA), there is no consensus on the optimal composition of the injection. In particular, it is not clear whether the addition of a corticosteroid improves the pain relief achieved nor whether it is associated with more complications than are observed without corticosteroid. The aim of this study was to quantify the safety and effectiveness of cortocosteroid use in periarticular injection during THA. Methods. We conducted a prospective, two-arm, parallel-group, randomized controlled trial involving patients scheduled for unilateral THA. A total of 187 patients were randomly assigned to receive periarticular injection containing either a corticosteroid (CS group) or without corticosteroid (no-CS group). Other perioperative interventions were identical for all patients. The primary outcome was postoperative pain at rest during the initial 24 hours after surgery. Pain score was recorded every three hours until 24 hours using a 100 mm visual analogue scale (VAS). The primary outcome was assessed based on the area under the curve (AUC). Results. The CS group had a significantly lower AUC postoperatively at 0 to 24 hours compared to the no-CS group (AUC of VAS score at rest 550 ± 362 vs 392 ± 320, respectively; mean difference 158 mm; 95% confidence interval (CI) 58 to 257; p = 0.0021). In point-by-point evaluation, the CS group had significantly lower VAS scores at 12, 15, 18, 21, 24, and 48 hours. There were no significant differences in complication rates, including surgical site infection, between the two groups. Conclusion. The addition of corticosteroid to periarticular injections reduces postoperative pain without increasing complication rate following THA. Cite this article: Bone Joint J 2020;102-B(10):1297–1302


Bone & Joint Research
Vol. 6, Issue 3 | Pages 162 - 171
1 Mar 2017
Walker JA Ewald TJ Lewallen E Van Wijnen A Hanssen AD Morrey BF Morrey ME Abdel MP Sanchez-Sotelo J

Objectives. Sustained intra-articular delivery of pharmacological agents is an attractive modality but requires use of a safe carrier that would not induce cartilage damage or fibrosis. Collagen scaffolds are widely available and could be used intra-articularly, but no investigation has looked at the safety of collagen scaffolds within synovial joints. The aim of this study was to determine the safety of collagen scaffold implantation in a validated in vivo animal model of knee arthrofibrosis. Materials and Methods. A total of 96 rabbits were randomly and equally assigned to four different groups: arthrotomy alone; arthrotomy and collagen scaffold placement; contracture surgery; and contracture surgery and collagen scaffold placement. Animals were killed in equal numbers at 72 hours, two weeks, eight weeks, and 24 weeks. Joint contracture was measured, and cartilage and synovial samples underwent histological analysis. Results. Animals that underwent arthrotomy had equivalent joint contractures regardless of scaffold implantation (-13.9° versus -10.9°, equivalence limit 15°). Animals that underwent surgery to induce contracture did not demonstrate equivalent joint contractures with (41.8°) or without (53.9°) collagen scaffold implantation. Chondral damage occurred in similar rates with (11 of 48) and without (nine of 48) scaffold implantation. No significant difference in synovitis was noted between groups. Absorption of the collagen scaffold occurred within eight weeks in all animals. Conclusion. Our data suggest that intra-articular implantation of a collagen sponge does not induce synovitis or cartilage damage. Implantation in a native joint does not seem to induce contracture. Implantation of the collagen sponge in a rabbit knee model of contracture may decrease the severity of the contracture. Cite this article: J. A. Walker, T. J. Ewald, E. Lewallen, A. Van Wijnen, A. D. Hanssen, B. F. Morrey, M. E. Morrey, M. P. Abdel, J. Sanchez-Sotelo. Intra-articular implantation of collagen scaffold carriers is safe in both native and arthrofibrotic rabbit knee joints. Bone Joint Res 2016;6:162–171. DOI: 10.1302/2046-3758.63.BJR-2016-0193


Bone & Joint Open
Vol. 4, Issue 8 | Pages 621 - 627
22 Aug 2023
Fishley WG Paice S Iqbal H Mowat S Kalson NS Reed M Partington P Petheram TG

Aims

The rate of day-case total knee arthroplasty (TKA) in the UK is currently approximately 0.5%. Reducing length of stay allows orthopaedic providers to improve efficiency, increase operative throughput, and tackle the rising demand for joint arthroplasty surgery and the COVID-19-related backlog. Here, we report safe delivery of day-case TKA in an NHS trust via inpatient wards with no additional resources.

Methods

Day-case TKAs, defined as patients discharged on the same calendar day as surgery, were retrospectively reviewed with a minimum follow-up of six months. Analysis of hospital and primary care records was performed to determine readmission and reattendance rates. Telephone interviews were conducted to determine patient satisfaction.


The Bone & Joint Journal
Vol. 106-B, Issue 7 | Pages 642 - 645
1 Jul 2024
Harris IA Sidhu VS MacDessi SJ Solomon M Haddad FS


The Bone & Joint Journal
Vol. 105-B, Issue 4 | Pages 382 - 388
15 Mar 2023
Haque A Parsons H Parsons N Costa ML Redmond AC Mason J Nwankwo H Kearney RS

Aims

The aim of this study was to compare the longer-term outcomes of operatively and nonoperatively managed patients treated with a removable brace (fixed-angle removable orthosis) or a plaster cast immobilization for an acute ankle fracture.

Methods

This is a secondary analysis of a multicentre randomized controlled trial comparing adults with an acute ankle fracture, initially managed either by operative or nonoperative care. Patients were randomly allocated to receive either a cast immobilization or a fixed-angle removable orthosis (removable brace). Data were collected on baseline characteristics, ankle function, quality of life, and complications. The Olerud-Molander Ankle Score (OMAS) was the primary outcome which was used to measure the participant’s ankle function. The primary endpoint was at 16 weeks, with longer-term follow-up at 24 weeks and two years.


The Bone & Joint Journal
Vol. 95-B, Issue 11_Supple_A | Pages 74 - 76
1 Nov 2013
Kamath AF McAuliffe CL Gutsche JT Kosseim LM Hume EL Baldwin KD Kornfield Z Israelite CL

Patient safety is a critical issue in elective total joint replacement surgery. Identifying risk factors that might predict complications and intensive care unit (ICU) admission proves instrumental in reducing morbidity and mortality. The institution’s experience with risk stratification and pre-operative ICU triage has resulted in a reduction in unplanned ICU admissions and post-operative complications after total hip replacement. The application of the prediction tools to total knee replacement has proven less robust so far. This work also reviews areas for future research in patient safety and cost containment. . Cite this article: Bone Joint J 2013;95-B, Supple A:74–6


Bone & Joint Open
Vol. 5, Issue 3 | Pages 184 - 201
7 Mar 2024
Achten J Marques EMR Pinedo-Villanueva R Whitehouse MR Eardley WGP Costa ML Kearney RS Keene DJ Griffin XL

Aims

Ankle fracture is one of the most common musculoskeletal injuries sustained in the UK. Many patients experience pain and physical impairment, with the consequences of the fracture and its management lasting for several months or even years. The broad aim of ankle fracture treatment is to maintain the alignment of the joint while the fracture heals, and to reduce the risks of problems, such as stiffness. More severe injuries to the ankle are routinely treated surgically. However, even with advances in surgery, there remains a risk of complications; for patients experiencing these, the associated loss of function and quality of life (Qol) is considerable. Non-surgical treatment is an alternative to surgery and involves applying a cast carefully shaped to the patient’s ankle to correct and maintain alignment of the joint with the key benefit being a reduction in the frequency of common complications of surgery. The main potential risk of non-surgical treatment is a loss of alignment with a consequent reduction in ankle function. This study aims to determine whether ankle function, four months after treatment, in patients with unstable ankle fractures treated with close contact casting is not worse than in those treated with surgical intervention, which is the current standard of care.

Methods

This trial is a pragmatic, multicentre, randomized non-inferiority clinical trial with an embedded pilot, and with 12 months clinical follow-up and parallel economic analysis. A surveillance study using routinely collected data will be performed annually to five years post-treatment. Adult patients, aged 60 years and younger, with unstable ankle fractures will be identified in daily trauma meetings and fracture clinics and approached for recruitment prior to their treatment. Treatments will be performed in trauma units across the UK by a wide range of surgeons. Details of the surgical treatment, including how the operation is done, implant choice, and the recovery programme afterwards, will be at the discretion of the treating surgeon. The non-surgical treatment will be close-contact casting performed under anaesthetic, a technique which has gained in popularity since the publication of the Ankle Injury Management (AIM) trial. In all, 890 participants (445 per group) will be randomly allocated to surgical or non-surgical treatment. Data regarding ankle function, QoL, complications, and healthcare-related costs will be collected at eight weeks, four and 12 months, and then annually for five years following treatment. The primary outcome measure is patient-reported ankle function at four months from treatment.