Abstract. Objectives. The purpose of this trial is to investigate the safety and efficacy of immediate weight-bearing (IWB) and range of motion exercise regimes following ORIF of unstable ankle fractures with a particular focus on functional outcomes and complication rates. Methods. A pragmatic randomised controlled multicentre trial, comparing IWB in a walking boot and ROM within 24 hours versus NWB and immobilisation in a cast for six weeks, following ORIF of all types of unstable adult ankle fractures. The exclusion criteria are skeletal immaturity and tibial plafond fractures. The primary outcome measure is the functional Olerud-Molander Ankle Score (OMAS). Secondary outcomes include wound infection, displacement of osteosynthesis, the full arc of ankle motion, RAND-36 Item Short Form Survey (SF-36) scoring, time to return to work and postoperative hospital length of stay. Results. We recruited 160 patients with an unstable ankle fracture. Participants’ ages ranged from 15 to 94 years (M = 45.5, SD = 17.2), with 54% identified as female. The mean time from injury to surgical fixation was 1.3 days (0 to 17 days). Patients in the IWB group had a 9.5-point higher mean OMAS at six weeks postoperatively (95% CI 1.48, 17.52) P = 0.021 with a similar result at three months. The complications rate was similar in both groups. The rate of surgical site infection was 4.3%. One patient had DVT, and another patient had a PE, both were randomised to NWB. Length of hospital stay was 1 ± 1.5 (0, 12) for the IWB group vs 1.5 ± 2.5 (0, 19) for the NWB group. Conclusion. In this large multicentre RCT, we investigated WB following ORIF of all ankle fracture patterns in the usual care condition using standard fixation methods. Our result suggests that IWB following ankle fracture fixation is safe and resulted in a better functional outcome

Introduction and Objective. Ankle fractures are common and affect young adults as well as the elderly. An unstable ankle fracture treatment typically involves surgical fixation, immobilisation, and modified weight-bearing for six weeks. Non-weight bearing (NWB) cast immobilisation periods were used to protect the soft tissue envelope and osteosynthesis. This can have implications on patient function and may reduce independence, mobility and return to work. Newer trends in earlier mobilisation compete with traditional NWB doctrine, and weak consensus exists as to the best postoperative strategy. The purpose of this trial is to investigate the safety and efficacy of immediate weight-bearing (IWB) and range of motion (ROM) exercise regimes following ORIF of unstable ankle fractures with a particular focus on functional outcomes and complication rates. Materials and Methods. A pragmatic randomised controlled multicentre trial, comparing IWB in a walking boot and ROM within 24 hours versus non-weight-bearing (NWB) and immobilisation in a cast for six weeks, following ORIF of all types of unstable adult ankle fractures (lateral malleolar, bimalleolar, trimalleolar with or without syndesmotic injury). The exclusion criteria are skeletal immaturity and tibial plafond fractures. The primary outcome measure is the functional Olerud-Molander Ankle Score (OMAS). Secondary outcomes include wound infection (deep and superficial), displacement of osteosynthesis, the full arc of ankle motion (plantar flexion and dorsal flection), RAND-36 Item Short Form Survey (SF-36) scoring, time to return to work and postoperative hospital length of stay. Results. We recruited 160 patients with an unstable ankle fracture. Participants’ ages ranged from 15 to 94 years (M = 45.5, SD = 17.2), with 54% identified as female. The mean time from injury to surgical fixation was 1.3 days (0 to 17 days). Patients in the immediate weight-bearing group had a 9.5-point higher mean OMAS at six weeks postoperatively (95% CI 1.48, 17.52) P = 0.021. The complications rate was similar in both groups. The rate of surgical site infection was 4.3%. One patient had DVT, and another patient had a pulmonary embolism; both were randomised to NWB. Length of hospital stay (LOS) was 1 ± 1.5 (0, 12) for the IWB group vs 1.5 ± 2.5 (0, 19) for the NWB group. Conclusions. There is a paucity of quality evidence supporting the postoperative management regimes used most commonly in clinical practice. To our knowledge, immediate weight-bearing (IWB) following ORIF of all types of unstable ankle fractures has not been investigated in a controlled prospective manner in recent decades. In this large multicentre, randomised controlled trial, we investigated immediate weight-bearing following ORIF of all ankle fracture patterns in the usual care condition using standard fixation methods. Our result suggests that IWB following ankle fracture fixation is safe and resulted in a better functional outcome. Once anatomical reduction and stable internal fixation is achieved, we recommend IWB in all types of ankle fractures in a compliant patient

The timing of definitive fracture fixation after Damage Control Surgery (DCS) remains a problem. Our unit employs a pragmatic approach, timing definitive surgery when the patient's clinical condition is judged satisfactory. Previous data implies fixation may result in a significant ‘second hit’ if executed <5 days after admission and DCS. The response to definitive fracture fixation in adult major trauma patients requiring DCS (MT ISS>25, n= 11) with fractures of the femoral shaft, pelvis or acetabulum were studied in comparison to patients with those fractures in isolation (IF n=21) and uninjured comparable surgical controls (SC n=12). Interleukin-8 (IL-8), IL-6 and sIL-6R levels, and neutrophil CD11b & monocyte HLA-DR expression were studied at admission, preoperatively and on days 2 & 5 post-operatively. Patients were divided into those undergoing definitive surgery within the first 5 days of admission (MT1st5 & IF1st5) or later (MTL & IFL). IL-8 levels were elevated in MT patients throughout, suggesting a proinflammatory state, whereas IL-6 levels were elevated but then declined steadily. This was independant of timing of surgery. The only post-operative rise observed was in IL-6 in SC patients. sIL-6R levels were increased in MT compared to IF patients post surgery. This elevated state, following increased IL-6 levels may be associated with resolution of the inflammatory response. CD11b expression in the MT group was unaffected. HLA-DR expression was reduced in the MT1st5 group, and post surgery in SC and IF1st5 groups. No post op cases of ARDS/MODS were diagnosed. These data suggest there is no associated detrimental effect upon the systemic inflammatory response even when undertaken less than 5 days from admission & DCS, and thus support a pragmatic approach in timing definitive fracture surgery based upon the patient's clinical improvement

Is Non-Weight-Bearing Necessary? (INWN) is a pragmatic multicentre randomised controlled trial comparing immediate protected weight-bearing (IWB) with non-weight-bearing cast immobilisation (NWB) following ankle fracture fixation (ORIF). This trial compares; functional outcomes, complication rates and performs an economic analysis to estimate cost-utility. IWB within 24hrs was compared to NWB, following ORIF of all types of unstable ankle fractures. Skeletally immature patients and tibial plafond fractures were excluded. Functional outcomes were assessed by the Olerud-Molander Ankle Score (OMAS) and RAND-36 Item Short Form Survey (SF-36) taken at regular follow-up intervals up to one year. A cost-utility analysis via decision tree modelling was performed to derive an incremental cost effectiveness ratio (ICER). A standard gamble health state valuation model utilising SF-36 scores was used to calculate Quality Adjusted Life Years (QALYs) for each arm. We recruited 160 patients (80 per arm), aged 15 to 94 years (M = 45.5), 54% female. Complication rates were similar in both groups. IWB demonstrated a consistently higher OMAS score, with significant values at 6 weeks (MD=10.4, p=0.005) and 3 months (MD 12.0, p=0.003). Standard gamble utility values demonstrated consistently higher values (a score of 1 equals perfect health) with IWB, significant at 3 months (Ẋ = 0.75 [IWB] / 0.69 [NWB], p=0.018). Cost-utility analysis demonstrated NWB is €798.02 more expensive and results in 0.04 fewer QALYs over 1 year. This results in an ICER of −€21,682.42/QALY. This negative ICER indicates cost savings of €21,682.42 for every QALY (25 patients = 1 QALY gain) gained implementing an IWB regime. IWB demonstrates a superior functional outcome, greater cost savings and similar complication rates, compared to NWB following ankle fracture fixation

Abstract. Objectives. Review the evidence of low intensity pulsed ultrasound (LIPUS) for fracture non-union treatment and the potential to treat fractures in patients with co-morbidities at risk of fracture non-union. Methods. Data was gathered from both animal and human studies of fracture repair to provide an overview of the LIPUS in bone healing applications to provide in-depth evidence to substantiate the use in treatment of non-union fractures and to propose a scientific rational to develop a clinical development programme. Results. LIPUS is an effective method for treating fracture non-union, with most studies showing heal rates in the mid 80%. In the UK NICE has published MTG-12 guidance for non-union treatment, which demonstrates that LIPUS is an effective and cost effective method as an alternative to surgery to treat non-union fractures. Basic science studies and evaluation of clinical trial data has led to the understanding that LIPUS can mitigate co-morbidities related to failure of bone healing such as diabetes, advancing age and tobacco use. Future clinical trials will evaluate the use of LIPUS in acute fractures in patients with high risk of low bone healing capacity to prevent the development of a non-union. As with all medical treatments, LIPUS for fracture repair needs to be used appropriately, with poorly fixed fractures or large fracture gaps, being unsuitable for LIPUS treatment. In addition, considerations such as targeting the fracture site in deep-seated bones and clinician / patient engagement to ensure good compliant usage are vital factors to ensure good clinical outcomes. Conclusion. Using basic science research, a thorough knowledge of the mechanism of action has been established, which has elucidated that co-morbidities related to the development of fracture non-union can be mitigated by the LIPUS technology. A pragmatic clinical trial in the United States is currently ongoing to test these hypothesises clinically. Declaration of Interest. (a) fully declare any financial or other potential conflict of interest

Prosthetic joint infection (PJI) is an uncommon but serious complication of hip replacement. Over 1,000 operations are performed annually in the United Kingdom for PJI following hip replacement, using either one- or two-stage revision arthroplasty. It is unclear which is preferred by patients and which has the best long-term outcome. This qualitative study aims to describe patient experiences of treatment and recovery following one- and two-stage revision arthroplasty for PJI within the context of a pragmatic randomised controlled trial comparing these two approaches. Semi-structured interviews were conducted with 32 patients undergoing one- or two-stage revision treatment for PJI as part of a UK multi-centre randomised controlled trial. Patients were recruited from 12 participating National Health Service (NHS) Orthopaedic Departments and were interviewed 2–4 months after their first revision surgery and again approximately 18 months later. Final sample size was justified on the basis of thematic saturation. All patients consented to the interview being audio-recorded, transcribed, anonymised and analysed using an inductive thematic approach. Ethical approval was provided by NRES Committee South-West Frenchay, 14/SW/116. Patients in both the one- and two-stage treatment groups described prolonged hospital stays, with burdensome antibiotics and brief physiotherapy treatment. However, following discharge home and during recovery, participants undergoing two-stage revision with an ‘empty hip' or with a spacer reported being physically restricted in almost every aspect of their daily life, resulting in inactivity and confinement to home. Mobility aids were not sufficiently available through the health service for these patients. A key difference is that those with a spacer reported more pain than those without. Approximately one year following their second-stage revision, participants described being more independent and active, but two directly attributed muscle weakness to the lengthy period without a hip and described resulting falls or dislocations that had complicated their recovery. In contrast, those undergoing one-stage revision and CUMARS appeared to be more alike, reporting better mobility, functionality and independence, although still limited. Participants in these groups also reported minimal or no pain following their revision. A key difference between CUMARS and one-stage revision was the uncertainty of whether a second operation was necessary, which participants described as “hanging over them”, while those in the two-stage empty hip or spacer group described a more positive anticipation of a second definitive operation as it marked an end to what was described as a detachment from life. Our findings highlight the differences between patient experiences of recovery following revision arthroplasty, and how this is influenced by the surgical approach and presence or lack of spacers. An understanding of lived experiences following one- and two-stage surgical interventions will complement knowledge about the clinical effectiveness of these different types of revision surgery

This protocol describes a pragmatic multicentre randomised controlled trial (RCT) to assess the clinical and cost effectiveness of arthroscopic and open surgery in the management of rotator cuff tears. This trial began in 2007 and was modified in 2010, with the removal of a non-operative arm due to high rates of early crossover to surgery. . Cite this article: Bone Joint Res 2014;3:155–60

Background. Patients with hand injuries frequently present to Emergency Departments. The ability of junior doctors to perform an accurate clinical assessment is crucial in initiating appropriate management. Objectives. To assess the adequacy of junior doctor hand examination skills and to establish whether further training and education is required. Methods. A double-centre study was conducted using an anonymous survey assessing hand examination completed by junior doctors (Foundation year 1 and Senior House Officer grades) working in Trauma & Orthopaedics or Emergency Departments. The survey covered all aspects of hand examination including assessment of: Flexor and Extensor tendons, Nerves (motor and sensory) and Vascular status. Surveys were marked against answers pre-agreed with a Consultant hand surgeon. Results. 32 doctors completed the survey. Tendons: 59% could accurately examine extensor digitorum, 41% extensor pollicis longus, 38% flexor digitorum profundus and 28% flexor digitorum superficialis. Nerves – Motor: 53% could accurately examine the radial nerve, 37% the ulnar nerve, 22% the median nerve and 9% the anterior interosseous nerve. Nerves – Sensory: 88% could accurately examine the radial nerve, 81% the ulnar nerve, 84% the median nerve and 18.8% digital nerves. Vascular: 93% could describe 3 methods of assessing vascularity. Conclusions. Tendon and neurological aspects of hand clinical examination were poorly executed at junior doctor level in this pragmatic survey. This highlights the need for targeted education and training to improve the accuracy of junior doctor hand injury assessment and subsequent improving patient treatment and safety. Recommendations include dedicated hand examination teaching early in Orthopaedic/A&E placements and introduction of an illustrated Hand Trauma Examination Proforma. Level of evidence. III - Evidence from case, correlation, and comparative studies

Purpose. Platelet Rich Plasma (PRP) has been shown to have positive effect in tendon regeneration in in-vitro and limited in-vivo animal studies. We aim to study PRP use in acute Achilles tendon rupture (ATR) regeneration in a purposely designed clinical trial. Methods. This is a prospective double-arm patient-blinded randomized controlled trial. ATR patients were randomized into PRP treatment or control groups. Non-operatively treated patients received PRP or control injection in clinic. In operatively treated patients, PRP gel was applied in the ruptured gap during percutaneous repair. Standard rehabilitation protocol was used and patients were followed up for 24 weeks. ATR, VISA-A and FAOS scores were used as subjective outcome measures. Functional ultrasound Elastography (FUSE) was performed at each follow-up to assess the mechanical properties of tendons. PRP analysis and tendon needle-biopsy were performed to study the histological differences during healing in both groups. Results. 20 patients were recruited with mean age 37.5±8.8 (8males and 7 females). Rupture location was 4.8±2.1 cm from insertion. PRP platelet count 1044±320 × 1000/μL with average platelet CD62p activation 68.42±4.5%. Mixed linear regression analysis revealed PRP treated tendon achieved better ATR and VISA-A outcome scores (p<0.05). FAOS score analysis showed that PRP group had better pain, ADL and symptoms scores with significant difference apparent from week 3 onwards. Strain mapping using FUSE scan in 4 patients showed bigger harder tendons in PRP group. Analysis of the remaining patients is on the way. To achieve the desired statistical power in pragmatic settings, recruitment will continue in a multi-centre trial. Conclusion. Our preliminary findings show that PRP application in Achilles tendon rupture may lead to faster regeneration and return to function as supported by a combination of objective and subjective outcome measures

Objectives

To explore whether orthopaedic surgeons have adopted the Proximal Fracture of the Humerus: Evaluation by Randomisation (PROFHER) trial results routinely into clinical practice.

Objectives

This study reports on a secondary exploratory analysis of the early clinical outcomes of a randomised clinical trial comparing robotic arm-assisted unicompartmental knee arthroplasty (UKA) for medial compartment osteoarthritis of the knee with manual UKA performed using traditional surgical jigs. This follows reporting of the primary outcomes of implant accuracy and gait analysis that showed significant advantages in the robotic arm-assisted group.

Objectives

We have increased the dose of tranexamic acid (TXA) in our enhanced total joint recovery protocol at our institution from 15 mg/kg to 30 mg/kg (maximum 2.5 g) as a single, intravenous (IV) dose. We report the clinical effect of this dosage change.

We welcome letters to the Editor concerning articles that have recently been published. Such letters will be subject to the usual stages of selection and editing; where appropriate the authors of the original article will be offered the opportunity to reply.

Ovine articular chondrocytes were isolated from cartilage biopsy and culture expanded in vitro. Approximately 30 million cells per ml of cultured chondrocytes were incorporated with autologous plasma-derived fibrin to form a three-dimensional construct. Full-thickness punch hole defects were created in the lateral and medial femoral condyles. The defects were implanted with either an autologous ‘chondrocyte-fibrin’ construct (ACFC), autologous chondrocytes (ACI) or fibrin blanks (AF) as controls. Animals were killed after 12 weeks. The gross appearance of the treated defects was inspected and photographed. The repaired tissues were studied histologically and by scanning electron microscopy analysis.

All defects were assessed using the International Cartilage Repair Society (ICRS) classification. Those treated with ACFC, ACI and AF exhibited median scores which correspond to a nearly-normal appearance. On the basis of the modified O’Driscoll histological scoring scale, ACFC implantation significantly enhanced cartilage repair compared to ACI and AF. Using scanning electron microscopy, ACFC and ACI showed characteristic organisation of chondrocytes and matrices, which were relatively similar to the surrounding adjacent cartilage.

Implantation of ACFC resulted in superior hyaline-like cartilage regeneration when compared with ACI. If this result is applicable to humans, a better outcome would be obtained than by using conventional ACI.