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Bone & Joint Research
Vol. 2, Issue 2 | Pages 33 - 40
1 Feb 2013
Palmer AJR Thomas GER Pollard TCB Rombach I Taylor A Arden N Beard DJ Andrade AJ Carr AJ Glyn-Jones S

Objectives. The number of surgical procedures performed each year to treat femoroacetabular impingement (FAI) continues to rise. Although there is evidence that surgery can improve symptoms in the short-term, there is no evidence that it slows the development of osteoarthritis (OA). We performed a feasibility study to determine whether patient and surgeon opinion was permissive for a Randomised Controlled Trial (RCT) comparing operative with non-operative treatment for FAI. Methods. Surgeon opinion was obtained using validated questionnaires at a Specialist Hip Meeting (n = 61, 30 of whom stated that they routinely performed FAI surgery) and patient opinion was obtained from clinical patients with a new diagnosis of FAI (n = 31). Results. Clinical equipoise was demonstrated when surgeons were given clinical scenarios and asked whether they would manage a patient operatively or non-operatively. A total of 23 surgeons (77%) who routinely perform FAI surgery were willing to recruit patients into a RCT, and 28 patients (90%) were willing to participate. 75% of responding surgeons believed it was appropriate to randomise patients to non-operative treatment for ≥ 12 months. Conversely, only eight patients (26%) felt this was acceptable, although 29 (94%) were willing to continue non-operative treatment for six months. More patients were concerned about their risk of developing OA than their current symptoms, although most patients felt that the two were of equal importance. Conclusions. We conclude that a RCT comparing operative and non-operative management of FAI is feasible and should be considered a research priority. An important finding for orthopaedic surgical trials is that patients without life-threatening pathology appear willing to trial a treatment for six months without improvement in their symptoms


Bone & Joint Research
Vol. 5, Issue 10 | Pages 470 - 480
1 Oct 2016
Sabharwal S Patel NK Griffiths D Athanasiou T Gupte CM Reilly P

Objectives

The objective of this study was to perform a meta-analysis of all randomised controlled trials (RCTs) comparing surgical and non-surgical management of fractures of the proximal humerus, and to determine whether further analyses based on complexity of fracture, or the type of surgical intervention, produced disparate findings on patient outcomes.

Methods

A systematic review of the literature was performed identifying all RCTs that compared surgical and non-surgical management of fractures of the proximal humerus. Meta-analysis of clinical outcomes was performed where possible. Subgroup analysis based on the type of fracture, and a sensitivity analysis based on the type of surgical intervention, were also performed.


Bone & Joint Research
Vol. 6, Issue 11 | Pages 631 - 639
1 Nov 2017
Blyth MJG Anthony I Rowe P Banger MS MacLean A Jones B

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.

Methods

A total of 139 patients were recruited from a single centre. Patients were randomised to receive either a manual UKA implanted with the aid of traditional surgical jigs, or a UKA implanted with the aid of a tactile guided robotic arm-assisted system. Outcome measures included the American Knee Society Score (AKSS), Oxford Knee Score (OKS), Forgotten Joint Score, Hospital Anxiety Depression Scale, University of California at Los Angeles (UCLA) activity scale, Short Form-12, Pain Catastrophising Scale, somatic disease (Primary Care Evaluation of Mental Disorders Score), Pain visual analogue scale, analgesic use, patient satisfaction, complications relating to surgery, 90-day pain diaries and the requirement for revision surgery.


Bone & Joint Research
Vol. 5, Issue 4 | Pages 130 - 136
1 Apr 2016
Thornley P de SA D Evaniew N Farrokhyar F Bhandari M Ghert M

Objectives

Evidence -based medicine (EBM) is designed to inform clinical decision-making within all medical specialties, including orthopaedic surgery. We recently published a pilot survey of the Canadian Orthopaedic Association (COA) membership and demonstrated that the adoption of EBM principles is variable among Canadian orthopaedic surgeons. The objective of this study was to conduct a broader international survey of orthopaedic surgeons to identify characteristics of research studies perceived as being most influential in informing clinical decision-making.

Materials and Methods

A 29-question electronic survey was distributed to the readership of an established orthopaedic journal with international readership. The survey aimed to analyse the influence of both extrinsic (journal quality, investigator profiles, etc.) and intrinsic characteristics (study design, sample size, etc.) of research studies in relation to their influence on practice patterns.


Bone & Joint Research
Vol. 6, Issue 8 | Pages 506 - 513
1 Aug 2017
Sims AL Farrier AJ Reed MR Sheldon TA

Objectives

The objective of this study was to assess all evidence comparing the Thompson monoblock hemiarthroplasty with modular unipolar implants for patients requiring hemiarthroplasty of the hip with respect to mortality and complications.

Methods

A literature search was performed to identify all relevant literature. The population consisted of patients undergoing hemiarthroplasty of the hip for fracture. The intervention was hemiarthroplasty of the hip with a comparison between Thompson and modular unipolar prostheses.

Pubmed, Embase, CINAHL, Web of Science, PROSPERO and the Cochrane Central Register of Controlled Trials.

The study designs included were randomised controlled trials (RCTs), well designed case control studies and retrospective or prospective cohort studies. Studies available in any language, published at any time until September 2015 were considered. Studies were included if they contained mortality or complications.


Bone & Joint Research
Vol. 6, Issue 4 | Pages 204 - 207
1 Apr 2017
Fernandez MA Aquilina A Achten J Parsons N Costa ML Griffin XL

Objectives

The Sliding Hip Screw (SHS) is commonly used to treat trochanteric hip fractures. Fixation failure is a devastating complication requiring complex revision surgery. One mode of fixation failure is lag screw cut-out which is greatest in unstable fracture patterns and when the tip-apex distance of the lag screw is > 25 mm. The X-Bolt Dynamic Hip Plating System (X-Bolt Orthopaedics, Dublin, Ireland) is a new device which aims to reduce this risk of cut-out. However, some surgeons have reported difficulty minimising the tip-apex distance with subsequent concerns that this may lead to an increased risk of cut-out.

Patients and Methods

We measured the tip-apex distance from the intra-operative radiographs of 93 unstable trochanteric hip fractures enrolled in a randomised controlled trial (Warwick Hip Trauma Evaluation, WHiTE One trial). Participants were treated with either the sliding hip screw or the X-Bolt dynamic hip plating system. We also recorded the incidence of cut-out in both groups, at a median follow-up time of 17 months.


Bone & Joint Research
Vol. 6, Issue 5 | Pages 307 - 314
1 May 2017
Rendon JS Swinton M Bernthal N Boffano M Damron T Evaniew N Ferguson P Galli Serra M Hettwer W McKay P Miller B Nystrom L Parizzia W Schneider P Spiguel A Vélez R Weiss K Zumárraga JP Ghert M

Objectives

As tumours of bone and soft tissue are rare, multicentre prospective collaboration is essential for meaningful research and evidence-based advances in patient care. The aim of this study was to identify barriers and facilitators encountered in large-scale collaborative research by orthopaedic oncological surgeons involved or interested in prospective multicentre collaboration.

Methods

All surgeons who were involved, or had expressed an interest, in the ongoing Prophylactic Antibiotic Regimens in Tumour Surgery (PARITY) trial were invited to participate in a focus group to discuss their experiences with collaborative research in this area. The discussion was digitally recorded, transcribed and anonymised. The transcript was analysed qualitatively, using an analytic approach which aims to organise the data in the language of the participants with little theoretical interpretation.


Bone & Joint Research
Vol. 3, Issue 5 | Pages 155 - 160
1 May 2014
Carr AJ Rees JL Ramsay CR Fitzpatrick R Gray A Moser J Dawson J Bruhn H Cooper CD Beard DJ Campbell MK

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.


Bone & Joint Research
Vol. 5, Issue 1 | Pages 18 - 25
1 Jan 2016
Sims AL Parsons N Achten J Griffin XL Costa ML Reed MR

Background

Approximately half of all hip fractures are displaced intracapsular fractures. The standard treatment for these fractures is either hemiarthroplasty or total hip arthroplasty. The recent National Institute for Health and Care Excellence (NICE) guidance on hip fracture management recommends the use of ‘proven’ cemented stem arthroplasty with an Orthopaedic Device Evaluation Panel (ODEP) rating of at least 3B (97% survival at three years). The Thompsons prosthesis is currently lacking an ODEP rating despite over 50 years of clinical use, likely due to the paucity of implant survival data. Nationally, adherence to these guidelines is varied as there is debate as to which prosthesis optimises patient outcomes.

Design

This study design is a multi-centre, multi-surgeon, parallel, two arm, standard-of-care pragmatic randomised controlled trial. It will be embedded within the WHiTE Comprehensive Cohort Study (ISRCTN63982700). The main analysis is a two-way equivalence comparison between Hemi-Thompson and Hemi-Exeter polished taper with Unitrax head. Secondary outcomes will include radiological leg length discrepancy measured as per Bidwai and Willett, mortality, re-operation rate and indication for re-operation, length of index hospital stay and revision at four months. This study will be supplemented by the NHFD (National Hip Fracture Database) dataset.


Bone & Joint Research
Vol. 2, Issue 2 | Pages 18 - 25
1 Feb 2013
Kon E Filardo G Di Matteo B Perdisa F Marcacci M

Objectives

Matrix-assisted autologous chondrocyte transplantation (MACT) has been developed and applied in the clinical practice in the last decade to overcome most of the disadvantages of the first generation procedures. The purpose of this systematic review is to document and analyse the available literature on the results of MACT in the treatment of chondral and osteochondral lesions of the knee.

Methods

All studies published in English addressing MACT procedures were identified, including those that fulfilled the following criteria: 1) level I-IV evidence, 2) measures of functional or clinical outcome, 3) outcome related to cartilage lesions of the knee cartilage.


Bone & Joint Research
Vol. 3, Issue 7 | Pages 217 - 222
1 Jul 2014
Robertsson O Ranstam J Sundberg M W-Dahl A Lidgren L

We are entering a new era with governmental bodies taking an increasingly guiding role, gaining control of registries, demanding direct access with release of open public information for quality comparisons between hospitals. This review is written by physicians and scientists who have worked with the Swedish Knee Arthroplasty Register (SKAR) periodically since it began. It reviews the history of the register and describes the methods used and lessons learned.

Cite this article: Bone Joint Res 2014;3:217–22.


Bone & Joint Research
Vol. 3, Issue 5 | Pages 169 - 174
1 May 2014
Rangan A Jefferson L Baker P Cook L

The aim of this study was to review the role of clinical trial networks in orthopaedic surgery. A total of two electronic databases (MEDLINE and EMBASE) were searched from inception to September 2013 with no language restrictions. Articles related to randomised controlled trials (RCTs), research networks and orthopaedic research, were identified and reviewed. The usefulness of trainee-led research collaborations is reported and our knowledge of current clinical trial infrastructure further supplements the review. Searching yielded 818 titles and abstracts, of which 12 were suitable for this review. Results are summarised and presented narratively under the following headings: 1) identifying clinically relevant research questions; 2) education and training; 3) conduct of multicentre RCTs and 4) dissemination and adoption of trial results. This review confirms growing international awareness of the important role research networks play in supporting trials in orthopaedic surgery. Multidisciplinary collaboration and adequate investment in trial infrastructure are crucial for successful delivery of RCTs.

Cite this article: Bone Joint Res 2014;3:169–74.


Bone & Joint Research
Vol. 3, Issue 4 | Pages 123 - 129
1 Apr 2014
Perry DC Griffin XL Parsons N Costa ML

The surgical community is plagued with a reputation for both failing to engage and to deliver on clinical research. This is in part due to the absence of a strong research culture, however it is also due to a multitude of barriers encountered in clinical research; particularly those involving surgical interventions. ‘Trauma’ amplifies these barriers, owing to the unplanned nature of care, unpredictable work patterns, the emergent nature of treatment and complexities in the consent process. This review discusses the barriers to clinical research in surgery, with a particular emphasis on trauma. It considers how barriers may be overcome, with the aim to facilitate future successful clinical research.

Cite this article: Bone Joint Res 2014;3:123–9.


Bone & Joint Research
Vol. 3, Issue 5 | Pages 161 - 168
1 May 2014
Mundi R Chaudhry H Mundi S Godin K Bhandari M

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.


Bone & Joint Research
Vol. 2, Issue 7 | Pages 122 - 128
1 Jul 2013
Mukovozov I Byun S Farrokhyar F Wong I

Aims

We performed a systematic review of the literature to determine whether earlier surgical repair of acute rotator cuff tear (ARCT) leads to superior post-operative clinical outcomes.

Methods

The MEDLINE, Embase, CINAHL, Web of Science, Cochrane Libraries, controlled-trials.com and clinicaltrials.gov databases were searched using the terms: ‘rotator cuff’, or ‘supraspinatus’, or ‘infraspinatus’, or ‘teres minor’, or ‘subscapularis’ AND ‘surgery’ or ‘repair’. This gave a total of 15 833 articles. After deletion of duplicates and the review of abstracts and full texts by two independent assessors, 15 studies reporting time to surgery for ARCT repair were included. Studies were grouped based on time to surgery < 3 months (group A, seven studies), or > 3 months (group B, eight studies). Weighted means were calculated and compared using Student’s t-test.


Bone & Joint Research
Vol. 2, Issue 12 | Pages 276 - 284
1 Dec 2013
Karlakki S Brem M Giannini S Khanduja V Stannard J Martin R

Objectives

The period of post-operative treatment before surgical wounds are completely closed remains a key window, during which one can apply new technologies that can minimise complications. One such technology is the use of negative pressure wound therapy to manage and accelerate healing of the closed incisional wound (incisional NPWT).

Methods

We undertook a literature review of this emerging indication to identify evidence within orthopaedic surgery and other surgical disciplines. Literature that supports our current understanding of the mechanisms of action was also reviewed in detail.


Bone & Joint Research
Vol. 2, Issue 3 | Pages 58 - 65
1 Mar 2013
Johnson R Jameson SS Sanders RD Sargant NJ Muller SD Meek RMD Reed MR

Objectives

To review the current best surgical practice and detail a multi-disciplinary approach that could further reduce joint replacement infection.

Methods

Review of relevant literature indexed in PubMed.


Bone & Joint Research
Vol. 1, Issue 12 | Pages 324 - 332
1 Dec 2012
Verhelst L Guevara V De Schepper J Van Melkebeek J Pattyn C Audenaert EA

The aim of this review is to evaluate the current available literature evidencing on peri-articular hip endoscopy (the third compartment). A comprehensive approach has been set on reports dealing with endoscopic surgery for recalcitrant trochanteric bursitis, snapping hip (or coxa-saltans; external and internal), gluteus medius and minimus tears and endoscopy (or arthroscopy) after total hip arthroplasty. This information can be used to trigger further research, innovation and education in extra-articular hip endoscopy.