High-quality randomised controlled trials (RCTs) evaluating surgical therapies are fundamental to the delivery of evidence-based orthopaedics. Orthopaedic clinical trials have unique challenges; however, when these challenges are overcome, evidence from trials can be definitive in its impact on surgical practice. In this review, we highlight several issues that pose potential challenges to orthopaedic investigators aiming to perform surgical randomised controlled trials. We begin with a discussion on trial design issues, including the ethics of sham surgery, the importance of sample size, the need for patient-important outcomes, and overcoming expertise bias. We then explore features surrounding the execution of surgical randomised trials, including ethics review boards, the importance of organisational frameworks, and obtaining adequate funding.

Cite this article: Bone Joint Res 2014;3:161–8.

We examined the risk of thrombotic and major bleeding events in patients undergoing total hip and knee replacement (THR and TKR) treated with thromboprophylaxis, using nationwide population-based databases. We identified 83 756 primary procedures performed between 1997 and 2011. The outcomes were symptomatic venous thromboembolism (VTE), myocardial infarction (MI), stroke, death and major bleeding requiring hospitalisation within 90 days of surgery.

A total of 1114 (1.3%) and 483 (0.6%) patients experienced VTE and bleeding, respectively. The annual risk of VTE varied between 0.9% and 1.6%, and of bleeding between 0.4% and 0.8%. The risk of VTE and bleeding was unchanged over a 15-year period. A total of 0.7% of patients died within 90 days, with a decrease from 1% in 1997 to 0.6% in 2011 (p < 0.001). A high level of comorbidity and general anaesthesia were strong risk factors for both VTE and bleeding, with no difference between THR and TKR patients. The risk of both MI and stroke was 0.5%, which remained unchanged during the study period.

In this cohort study of patients undergoing THR and TKR patients in routine clinical practice, approximately 3% experienced VTE, MI, stroke or bleeding. These risks did not decline during the 15-year study period, but the risk of dying fell substantially.

Cite this article: Bone Joint J 2014;96-B:479–85.

The August 2013 Research Roundup³⁶⁰ looks at: passive smoking and bone substitutes; platelet-rich plasma and osteogenesis; plantar fasciitis and platelet-rich plasma: a match made in heaven?; MRSA decolonisation decreases infection rates; gums, bisphosphonates and orthopaedics; PRAISE and partner violence; blunt impact and post-traumatic OA; and IDEAL research and implants

The August 2013 Hip & Pelvis Roundup³⁶⁰ looks at: are we getting it right first time?; tantalum augments in revision hip surgery; lower wear in dual mobility?; changing faces changes outcomes; synovial fluid aspiration in MOM hips; taper disease: the new epidemic of hip surgery; the super-obese and THR; and whether well fixed stems can remain in infected hips

The August 2013 Children’s orthopaedics Roundup³⁶⁰ looks at: a multilevel approach to equinus gait; whether screening leads to needless intervention; salvage of subcapital slipped epiphysis; growing prostheses for children’s oncology; flexible nailing revisited; ultrasound and the pink pulseless hand; and slipping forearm fractures.

The strain on clinic and surgeon resources resulting from a rise in demand for total knee replacement (TKR) requires reconsideration of when and how often patients need to be seen for follow-up. Surgeons will otherwise require increased paramedical staff or need to limit the number of TKRs they undertake. We reviewed the outcome data of 16 414 primary TKRs undertaken at our centre to determine the time to re-operation for any reason and for specific failure mechanisms. Peak risk years for failure were determined by comparing the conditional probability of failure, the number of failures divided by the total number of TKRs cases, for each year. The median times to failure for the most common failure mechanisms were 4.9 years (interquartile range (IQR) 1.7 to 10.7) for femoral and tibial loosening, 1.9 years (IQR 0.8 to 3.9) for infection, 3.1 years (IQR 1.6 to 5.5) for tibial collapse and 5.6 years (IQR 3.4 to 9.3) for instability. The median time to failure for all revisions was 3.3 years (IQR 1.2 to 8.5), with an overall revision rate of 1.7% (n = 282). Results from our patient population suggest that patients be seen for follow-up at six months, one year, three years, eight years, 12 years, and every five years thereafter. Patients with higher pain in the early post-operative period or high body mass index (≥ 41 kg/m²) should be monitored more closely.

Cite this article: Bone Joint J 2013;95-B:1484–9.

Objectives

The Manchester–Oxford Foot Questionnaire (MOXFQ) is a validated 16-item, patient-reported outcome measure for evaluating outcomes of foot or ankle surgery. The original development of the instrument identified three domains. This present study examined whether the three domains could legitimately be summed to provide a single summary index score.

The June 2013 Knee Roundup³⁶⁰ looks at: knee arthroplasty in diabetic patients; whether TKR is a timebomb; the use of antidepressants for knee OA; trochleoplasty; articulated spacers; mental health and joint replacement; and the use of physiotherapy for meniscal tear.

The April 2013 Oncology Roundup³⁶⁰ looks at: the margin for error; new money for old risks; hindquarter amputation; custom tumour jigs; preserving the tibial epiphysis; how long is long enough?; genomics and radiation-induced bone tumours; and India ink.

Hip implant retrieval analysis is the most important source of insight into the performance of new materials and designs of hip arthroplasties. Even the most rigorous in vitro testing will not accurately simulate the behavior of implant materials and new designs of prosthetic arthroplasties. Retrieval analysis has revealed such factors as the effects of gamma-in-air sterilisation of polyethylene, fatigue failure mechanisms of polymethylmethacrylate bone cement, fretting corrosion of Morse taper junctions, third body wear effects of both hard-on-hard and hard-on-soft bearing couples, and the effects of impingement of components on the full spectrum of bearing surfaces, none of which was predicted by pre-implantation in vitro testing of these materials and combinations. The temporal sequence of the retrieval process is approximately six years from first implantation through retrieval analysis, laboratory investigation, and publication of results, and thus, in addition to rigorous clinical evaluation, represents the true development and insight cycle for new designs and materials.

The February 2013 Shoulder & Elbow Roundup³⁶⁰ looks at: whether we should replace fractured shoulders; the limited evidence for shoulder fractures; cuffs and early physio; matrix proteins and cuff tears; long-term SLAP tear outcomes; suture anchors; recurrent Bankart repairs; and acromial morphology and calcific tendonitis.

The February 2013 Hip & Pelvis Roundup³⁶⁰ looks at: amazing alumina; dual mobility; white cells and periprosthetic infection; cartilage and impingement surgery; acetabulum in combination; cementless ceramic prosthesis; metal-on-metal hips; and whether size matters in failure.

The December 2012 Hip & Pelvis Roundup³⁶⁰ looks at: swimming against the tide with resurfacing; hip impingement surgery; the relationship between obesity and co-morbidities and joint replacement infection; cemented hips; cross-linked polyethylene notching; whether cement is necessary in oncological arthroplasty; and how total hip replacement may result in weight gain.

The October 2012 Shoulder & Elbow Roundup³⁶⁰ looks at: fast-absorbing suture anchors for use in shoulder labral tears; double-row rotator cuff repair; degenerate massive rotator cuff tears addressed with partial repair; open and arthroscopic stabilisation of Bankart lesions; predicting the risk of revision humeral head replacement; arthroscopic treatment for frozen shoulder; and long-term follow-up of the Bristow-Latarjet procedure.

This brief annotation summarises the particular contributions made by the annual Edinburgh International Trauma Symposium in various areas of research into aspects of orthopaedic trauma and the management of acutely injured patients, during the 25 years since its establishment.

Controversy continues to surround the management of patients with an open fracture of the lower limb and an associated vascular injury (Gustilo type IIIC). This study reports our 15-year experience with these fractures and their outcome in 18 patients (15 male and three female). Their mean age was 30.7 years (8 to 54) and mean Mangled Extremity Severity Score (MESS) at presentation was 6.9 (3 to 10). A total of 15 lower limbs were salvaged and three underwent amputation (two immediate and one delayed). Four patients underwent stabilisation of the fracture by external fixation and 12 with an internal device. A total of 11 patients had damage to multiple arteries and eight had a vein graft. Wound cover was achieved with a pedicled flap in three and a free flap in six. Seven patients developed a wound infection and four developed nonunion requiring further surgery. At a mean follow-up of five years (4.1 to 6.6) the mean visual analogue scale for pain was 64 (10 to 90). Depression and anxiety were common. Activities were limited mainly because of pain, and the MESS was a valid predictor of the functional outcome. Distal tibial fractures had an increased rate of nonunion when associated with posterior tibial artery damage, and seven patients (39%) were not able to return to their previous occupation.

Patient-reported outcome measures (PROMs) are increasingly being used to assess functional outcome and patient satisfaction. They provide a framework for comparisons between surgical units, and individual surgeons for benchmarking and financial remuneration. Better performance may bring the reward of more customers as patients and commissioners seek out high performers for their elective procedures. Using National Joint Registry (NJR) data linked to PROMs we identified 22 691 primary total knee replacements (TKRs) undertaken for osteoarthritis in England and Wales between August 2008 and February 2011, and identified the surgical factors that influenced the improvements in the Oxford knee score (OKS) and EuroQol-5D (EQ-5D) assessment using multiple regression analysis. After correction for patient factors the only surgical factors that influenced PROMs were implant brand and hospital type (both p < 0.001). However, the effects of surgical factors upon the PROMs were modest compared with patient factors. For both the OKS and the EQ-5D the most important factors influencing the improvement in PROMs were the corresponding pre-operative score and the patient’s general health status. Despite having only a small effect on PROMs, this study has shown that both implant brand and hospital type do influence reported subjective functional scores following TKR. In the current climate of financial austerity, proposed performance-based remuneration and wider patient choice, it would seem unwise to ignore these effects and the influence of a range of additional patient factors.

Fractures and nonunions of the proximal humerus are increasingly treated by open reduction and internal fixation. The extended deltopectoral approach remains the most widely used for this purpose. However, it provides only limited exposure of the lateral and posterior aspects of the proximal humerus. We have previously described the alternative extended deltoid-splitting approach. In this paper we outline variations and extensions of this technique that we have developed in the management of further patients with these fractures.