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Bone & Joint Research
Vol. 4, Issue 9 | Pages 154 - 162
1 Sep 2015

Objective

Clinical studies of patients with bone sarcomas have been challenged by insufficient numbers at individual centres to draw valid conclusions. Our objective was to assess the feasibility of conducting a definitive multi-centre randomised controlled trial (RCT) to determine whether a five-day regimen of post-operative antibiotics, in comparison to a 24-hour regimen, decreases surgical site infections in patients undergoing endoprosthetic reconstruction for lower extremity primary bone tumours.

Methods

We performed a pilot international multi-centre RCT. We used central randomisation to conceal treatment allocation and sham antibiotics to blind participants, surgeons, and data collectors. We determined feasibility by measuring patient enrolment, completeness of follow-up, and protocol deviations for the antibiotic regimens.


The Bone & Joint Journal
Vol. 97-B, Issue 3 | Pages 306 - 311
1 Mar 2015
Weber M Lechler P von Kunow F Völlner F Keshmiri A Hapfelmeier A Grifka J Renkawitz T

Femoral stem version has a major influence on impingement and early post-operative stability after total hip arthroplasty (THA).

The main objective of this study was to evaluate the validity of a novel radiological method for measuring stem version. Anteroposterior (AP) radiographs and three-dimensional CT scans were obtained for 115 patients (female/male 63/72, mean age 62.5 years (50 to 75)) who had undergone minimally invasive, cementless THA. Stem version was calculated from the AP hip radiograph by rotation-based change in the projected prosthetic neck–shaft (NSA*) angle using the mathematical formula ST = arcos [tan (NSA*) / tan (135)]. We used two independent observers who repeated the analysis after a six-week interval. Radiological measurements were compared with 3D-CT measurements by an independent, blinded external institute.

We found a mean difference of 1.2° (sd 6.2) between radiological and 3D-CT measurements of stem version. The correlation between the mean radiological and 3D-CT stem torsion was r = 0.88 (p < 0.001). The intra- (intraclass correlation coefficient ≥ 0.94) and inter-observer agreement (mean concordance correlation coefficient = 0.87) for the radiological measurements were excellent.

We found that femoral tilt was associated with the mean radiological measurement error (r = 0.22, p = 0.02).

The projected neck–shaft angle is a reliable method for measuring stem version on AP radiographs of the hip after a THA. However, a highly standardised radiological technique is required for its precise measurement.

Cite this article: Bone Joint J 2015; 97-B:306–11.


The Bone & Joint Journal
Vol. 95-B, Issue 8 | Pages 1057 - 1063
1 Aug 2013
Zeng Y Shen B Yang J Zhou ZK Kang PD Pei FX

The purpose of this study was to undertake a meta-analysis to determine whether there is lower polyethylene wear and longer survival when using mobile-bearing implants in total knee replacement when compared with fixed-bearing implants. Of 975 papers identified, 34 trials were eligible for data extraction and meta-analysis comprising 4754 patients (6861 knees). We found no statistically significant differences between the two designs in terms of the incidence of radiolucent lines, osteolysis, aseptic loosening or survival. There is thus currently no evidence to suggest that the use of mobile-bearing designs reduce polyethylene wear and prolong survival after total knee replacement.

Cite this article: Bone Joint J 2013;95-B:1057–63.


The Bone & Joint Journal
Vol. 97-B, Issue 1 | Pages 3 - 9
1 Jan 2015
Hossain FS Konan S Patel S Rodriguez-Merchan EC Haddad FS

The routine use of patient reported outcome measures (PROMs) in evaluating the outcome after arthroplasty by healthcare organisations reflects a growing recognition of the importance of patients’ perspectives in improving treatment. Although widely embraced in the NHS, there are concerns that PROMs are being used beyond their means due to a poor understanding of their limitations.

This paper reviews some of the current challenges in using PROMs to evaluate total knee arthroplasty. It highlights alternative methods that have been used to improve the assessment of outcome.

Cite this article: Bone Joint J 2015;97-B:3–9.


The Bone & Joint Journal
Vol. 95-B, Issue 7 | Pages 952 - 959
1 Jul 2013
Cai X Yan S Giddins G

Most patients with a nightstick fracture of the ulna are treated conservatively. Various techniques of immobilisation or early mobilisation have been studied. We performed a systematic review of all published randomised controlled trials and observational studies that have assessed the outcome of these fractures following above- or below-elbow immobilisation, bracing and early mobilisation. We searched multiple electronic databases, related bibliographies and other studies. We included 27 studies comprising 1629 fractures in the final analysis. The data relating to the time to radiological union and the rates of delayed union and nonunion could be pooled and analysed statistically.

We found that early mobilisation produced the shortest radiological time to union (mean 8.0 weeks) and the lowest mean rate of nonunion (0.6%). Fractures treated with above- or below-elbow immobilisation and braces had longer mean radiological times to union (9.2 weeks, 9.2 weeks and 8.7 weeks, respectively) and higher mean rates of nonunion (3.8%, 2.1% and 0.8%, respectively). There was no statistically significant difference in the rate of non- or delayed union between those treated by early mobilisation and the three forms of immobilisation (p = 0.142 to p = 1.000, respectively). All the studies had significant biases, but until a robust randomised controlled trial is undertaken the best advice for the treatment of undisplaced or partially displaced nightstick fractures appears to be early mobilisation, with a removable forearm support for comfort as required.

Cite this article: Bone Joint J 2013;95-B:952–9.


The Bone & Joint Journal
Vol. 97-B, Issue 3 | Pages 372 - 382
1 Mar 2015
Griffin XL Parsons N Achten J Fernandez M Costa ML

Hip fracture is a global public health problem. The National Hip Fracture Database provides a framework for service evaluation in this group of patients in the United Kingdom, but does not collect patient-reported outcome data and is unable to provide meaningful data about the recovery of quality of life.

We report one-year patient-reported outcomes of a prospective cohort of patients treated at a single major trauma centre in the United Kingdom who sustained a hip fracture between January 2012 and March 2014.

There was an initial marked decline in quality of life from baseline measured using the EuroQol 5 Dimensions score (EQ-5D). It was followed by a significant improvement to 120 days for all patients. Although their quality of life improved during the year after the fracture, it was still significantly lower than before injury irrespective of age group or cognitive impairment (mean reduction EQ-5D 0.22; 95% confidence interval (CI) 0.17 to 0.26). There was strong evidence that quality of life was lower for patients with cognitive impairment. There was a mean reduction in EQ-5D of 0.28 (95% CI 0.22 to 0.35) in patients <  80 years of age. This difference was consistent (and fixed) throughout follow-up. Quality of life does not improve significantly during recovery from hip fracture in patients over 80 years of age (p = 0.928). Secondary measures of function showed similar trends.

Hip fracture marks a step down in the quality of life of a patient: it accounts for approximately 0.22 disability adjusted life years in the first year after fracture. This is equivalent to serious neurological conditions for which extensive funding for research and treatment is made available.

Cite this article: Bone Joint J 2015;97-B:372–82.


Bone & Joint Research
Vol. 3, Issue 11 | Pages 321 - 327
1 Nov 2014
Palmer AJR Ayyar-Gupta V Dutton SJ Rombach I Cooper CD Pollard TC Hollinghurst D Taylor A Barker KL McNally EG Beard DJ Andrade AJ Carr AJ Glyn-Jones S

Aims

Femoroacetabular Junction Impingement (FAI) describes abnormalities in the shape of the femoral head–neck junction, or abnormalities in the orientation of the acetabulum. In the short term, FAI can give rise to pain and disability, and in the long-term it significantly increases the risk of developing osteoarthritis. The Femoroacetabular Impingement Trial (FAIT) aims to determine whether operative or non-operative intervention is more effective at improving symptoms and preventing the development and progression of osteoarthritis.

Methods

FAIT is a multicentre superiority parallel two-arm randomised controlled trial comparing physiotherapy and activity modification with arthroscopic surgery for the treatment of symptomatic FAI. Patients aged 18 to 60 with clinical and radiological evidence of FAI are eligible. Principal exclusion criteria include previous surgery to the index hip, established osteoarthritis (Kellgren–Lawrence ≥ 2), hip dysplasia (centre-edge angle < 20°), and completion of a physiotherapy programme targeting FAI within the previous 12 months. Recruitment will take place over 24 months and 120 patients will be randomised in a 1:1 ratio and followed up for three years. The two primary outcome measures are change in hip outcome score eight months post-randomisation (approximately six-months post-intervention initiation) and change in radiographic minimum joint space width 38 months post-randomisation. ClinicalTrials.gov: NCT01893034.

Cite this article: Bone Joint Res 2014;3:321–7.


The Bone & Joint Journal
Vol. 96-B, Issue 10 | Pages 1396 - 1403
1 Oct 2014
Salunke AA Chen Y Tan JH Chen X Khin LW Puhaindran ME

Opinion remains divided as to whether the development of pathological fracture affects the prognosis of patients with an osteosarcoma of the extremities.

We conducted a comprehensive systematic review and meta-analysis of papers which reported the outcomes of osteosarcoma patients with and without a pathological fracture. There were eight eligible papers for final analysis which reported on 1713 patients, of whom 303 (17.7%) had a pathological fracture. The mean age for 1464 patients in six studies was 23.2 years old (2 to 82). The mean follow-up for 1481 patients in seven studies was 90.1 months (6 to 240).

The pooled estimates of local recurrence rates in osteosarcoma patients with and without pathological fractures were 14.4% (8.7 to 20.0) versus 11.4% (8.0 to 14.8). The pooled estimate of relative risk was 1.39 (0.89 to 2.20). The pooled estimates of five-year event-free survival rates in osteosarcoma patients with and without a pathological fracture were 49.3% (95% CI 43.6 to 54.9) versus 66.8% (95% CI 60.7 to 72.8). The pooled estimate of relative risk was 1.33 (1.12 to 1.59). There was no significant difference in the rate of local recurrence between patients who were treated by amputation or limb salvage.

The development of a pathological fracture is a negative prognostic indicator in osteosarcoma and is associated with a reduced five-year event-free survival and a possibly higher rate of local recurrence. Our findings suggest that there is no absolute indication for amputation, as similar rates of local recurrence can be achieved in patients who are carefully selected for limb salvage.

Cite this article: Bone Joint J 2014; 96-B:1396–1403


Bone & Joint Research
Vol. 3, Issue 3 | Pages 48 - 50
1 Mar 2014
Lidgren L Gomez-Barrena E N. Duda G Puhl W Carr A


The Bone & Joint Journal
Vol. 96-B, Issue 5 | Pages 652 - 657
1 May 2014
Griffin XL Parsons N Achten J Costa ML

We compared a new fixation system, the Targon Femoral Neck (TFN) hip screw, with the current standard treatment of cannulated screw fixation. This was a single-centre, participant-blinded, randomised controlled trial. Patients aged 65 years and over with either a displaced or undisplaced intracapsular fracture of the hip were eligible. The primary outcome was the risk of revision surgery within one year of fixation.

A total of 174 participants were included in the trial. The absolute reduction in risk of revision was of 4.7% (95% CI 14.2 to 22.5) in favour of the TFN hip screw (chi-squared test, p = 0.741), which was less than the pre-specified level of minimum clinically important difference. There were no significant differences in any of the secondary outcome measures.

We found no evidence of a clinical difference in the risk of revision surgery between the TFN hip screw and cannulated screw fixation for patients with an intracapsular fracture of the hip.

Cite this article: Bone Joint J 2014;96-B:652–7.


The Bone & Joint Journal
Vol. 96-B, Issue 8 | Pages 1016 - 1023
1 Aug 2014
Haywood KL Griffin XL Achten J Costa ML

The lack of a consensus for core health outcomes that should be reported in clinical research has hampered study design and evidence synthesis. We report a United Kingdom consensus for a core outcome set (COS) for clinical trials of patients with a hip fracture.

We adopted a modified nominal group technique to derive consensus on 1) which outcome domains should be measured, and 2) methods of assessment. Participants reflected a diversity of perspectives and experience. They received an evidence synthesis and postal questionnaire in advance of the consensus meeting, and ranked the importance of candidate domains and the relevance and suitability of short-listed measures. During the meeting, pre-meeting source data and questionnaire responses were summarised, followed by facilitated discussion and a final plenary session. A COS was determined using a closed voting system: a 70% consensus was required.

Consensus supported a five-domain COS: mortality, pain, activities of daily living, mobility, and health-related quality of life (HRQL). Single-item measures of mortality and mobility (indoor/outdoor walking status) and a generic multi-item measure of HRQL - the EuroQoL EQ-5D - were recommended. These measures should be included as a minimum in all hip fracture trials. Other outcome measures should be added depending on the particular interventions being studied.

Cite this article: Bone Joint J 2014; 96-B:1016–23.


The Bone & Joint Journal
Vol. 96-B, Issue 11 | Pages 1464 - 1471
1 Nov 2014
Lindberg-Larsen M Jørgensen CC Hansen TB Solgaard S Kehlet H

Data on early morbidity and complications after revision total hip replacement (THR) are limited. The aim of this nationwide study was to describe and quantify early morbidity after aseptic revision THR and relate the morbidity to the extent of the revision surgical procedure. We analysed all aseptic revision THRs from 1st October 2009 to 30th September 2011 using the Danish National Patient Registry, with additional information from the Danish Hip Arthroplasty Registry. There were 1553 procedures (1490 patients) performed in 40 centres and we divided them into total revisions, acetabular component revisions, femoral stem revisions and partial revisions. The mean age of the patients was 70.4 years (25 to 98) and the median hospital stay was five days (interquartile range 3 to 7). Within 90 days of surgery, the readmission rate was 18.3%, mortality rate 1.4%, re-operation rate 6.1%, dislocation rate 7.0% and infection rate 3.0%. There were no differences in these outcomes between high- and low-volume centres. Of all readmissions, 255 (63.9%) were due to ‘surgical’ complications versus 144 (36.1%) ‘medical’ complications. Importantly, we found no differences in early morbidity across the surgical subgroups, despite major differences in the extent and complexity of operations. However, dislocations and the resulting morbidity represent the major challenge for improvement in aseptic revision THR.

Cite this article: Bone Joint J 2014; 96-B:1464–71.


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.


The Bone & Joint Journal
Vol. 96-B, Issue 2 | Pages 279 - 286
1 Feb 2014
Gardner ROE Bradley CS Howard A Narayanan UG Wedge JH Kelley SP

The incidence of clinically significant avascular necrosis (AVN) following medial open reduction of the dislocated hip in children with developmental dysplasia of the hip (DDH) remains unknown. We performed a systematic review of the literature to identify all clinical studies reporting the results of medial open reduction surgery. A total of 14 papers reporting 734 hips met the inclusion criteria. The mean follow-up was 10.9 years (2 to 28). The rate of clinically significant AVN (types 2 to 4) was 20% (149/734). From these papers 221 hips in 174 children had sufficient information to permit more detailed analysis. The rate of AVN increased with the length of follow-up to 24% at skeletal maturity, with type 2 AVN predominating in hips after five years’ follow-up. The presence of AVN resulted in a higher incidence of an unsatisfactory outcome at skeletal maturity (55% vs 20% in hips with no AVN; p < 0.001). A higher rate of AVN was identified when surgery was performed in children aged < 12 months, and when hips were immobilised in ≥ 60°of abduction post-operatively. Multivariate analysis showed that younger age at operation, need for further surgery and post-operative hip abduction of ≥ 60° increased the risk of the development of clinically significant AVN.

Cite this article: Bone Joint J 2014;96-B:279–86.


The Bone & Joint Journal
Vol. 95-B, Issue 12 | Pages 1714 - 1720
1 Dec 2013
Hamilton TW Hutchings L Alsousou J Tutton E Hodson E Smith CH Wakefield J Gray B Symonds S Willett K

We investigated whether, in the management of stable paediatric fractures of the forearm, flexible casts that can be removed at home are as clinically effective, cost-effective and acceptable to both patient and parent as management using a cast conventionally removed in hospital. A single-centre randomised controlled trial was performed on 317 children with a mean age of 9.3 years (2 to 16). No significant differences were seen in the change in Childhood Health Assessment Questionnaire index score (p = 0.10) or EuroQol 5-Dimensions domain scores between the two groups one week after removal of the cast or the absolute scores at six months. There was a significantly lower overall median treatment cost in the group whose casts were removed at home (£150.88 (sem 1.90) vs £251.62 (sem 2.68); p <  0.001). No difference was seen in satisfaction between the two groups (p = 0.48).

Cite this article: Bone Joint J 2013;95-B:1714–20.


The Bone & Joint Journal
Vol. 95-B, Issue 1 | Pages 2 - 3
1 Jan 2013
Costa ML Stengel D Griffin XL Carey Smith R Parsons N


The Bone & Joint Journal
Vol. 95-B, Issue 11 | Pages 1544 - 1550
1 Nov 2013
Uchiyama S Itsubo T Nakamura K Fujinaga Y Sato N Imaeda T Kadoya M Kato H

This multicentre prospective clinical trial aimed to determine whether early administration of alendronate (ALN) delays fracture healing after surgical treatment of fractures of the distal radius. The study population comprised 80 patients (four men and 76 women) with a mean age of 70 years (52 to 86) with acute fragility fractures of the distal radius requiring open reduction and internal fixation with a volar locking plate and screws. Two groups of 40 patients each were randomly allocated either to receive once weekly oral ALN administration (35 mg) within a few days after surgery and continued for six months, or oral ALN administration delayed until four months after surgery. Postero-anterior and lateral radiographs of the affected wrist were taken monthly for six months after surgery. No differences between groups was observed with regard to gender (p = 1.0), age (p = 0.916), fracture classification (p = 0.274) or bone mineral density measured at the spine (p = 0.714). The radiographs were assessed by three independent assessors. There were no significant differences in the mean time to complete cortical bridging observed between the ALN group (3.5 months (se 0.16)) and the no-ALN group (3.1 months (se 0.15)) (p = 0.068). All the fractures healed in the both groups by the last follow-up. Improvement of the Quick-Disabilities of the Arm, Shoulder and Hand (QuickDASH) score, grip strength, wrist range of movement, and tenderness over the fracture site did not differ between the groups over the six-month period. Based on our results, early administration of ALN after surgery for distal radius fracture did not appear to delay fracture healing times either radiologically or clinically.

Cite this article: Bone Joint J 2013;95-B:1544–50.


The Journal of Bone & Joint Surgery British Volume
Vol. 93-B, Issue 1 | Pages 39 - 46
1 Jan 2011
Sukeik M Alshryda S Haddad FS Mason JM

We report a systematic review and meta-analysis of published randomised controlled trials evaluating the efficacy of tranexamic acid (TXA) in reducing blood loss and transfusion in total hip replacement (THR). The data were evaluated using the generic evaluation tool designed by the Cochrane Bone, Joint and Muscle Trauma Group. We identified 11 clinical trials which were suitable for detailed extraction of data. There were no trials that used TXA in revision THR. A total of seven studies (comprising 350 patients) were eligible for the blood loss outcome data. The use of TXA reduced intra-operative blood loss by a mean of 104 ml (95% confidence interval (CI) −164 to −44, p = 0.0006, heterogeneity I2 0%), postoperative blood loss by a mean of 172 ml (95% CI −263 to −81, p = 0.0002, heterogeneity I2 63%) and total blood loss by a mean of 289 ml (95% CI −440 to −138, p < 0.0002, heterogeneity I2 54%).

TXA led to a significant reduction in the proportion of patients requiring allogeneic blood transfusion (risk difference −0.20, 95% CI −0.29 to −0.11, p < 0.00001, I2 15%). There were no significant differences in deep-vein thrombosis, pulmonary embolism, infection rates or other complications among the study groups.


The Bone & Joint Journal
Vol. 95-B, Issue 7 | Pages 868 - 873
1 Jul 2013
Cho SK Lu Y Lee D

Dysphagia is a common complication of anterior surgery of the cervical spine. The incidence of post-operative dysphagia may be as high as 71% within the first two weeks after surgery, but gradually decreases during the following months. However, 12% to 14% of patients may have some persistent dysphagia one year after the procedure. It has been shown that female gender, advanced age, multilevel surgery, longer operating time and severe pre-operative neck pain may be risk factors. Although the aetiology remains unclear and is probably multifactorial, proposed causes include oesophageal retraction, prominence of the cervical plate and prevertebral swelling. Recently, pre-operative tracheal traction exercises and the use of retropharyngeal steroids have been proposed as methods of reducing post-operative dysphagia.

We performed a systematic review to assess the incidence, aetiology, risk factors, methods of assessment and management of dysphagia following anterior cervical spinal surgery.

Cite this article: Bone Joint J 2013;95-B:868–73.


The Bone & Joint Journal
Vol. 95-B, Issue 8 | Pages 1094 - 1100
1 Aug 2013
Baltzer H Binhammer PA

In Canada, Dupuytren's contracture is managed with partial fasciectomy or percutaneous needle aponeurotomy (PNA). Injectable collagenase will soon be available. The optimal management of Dupuytren’s contracture is controversial and trade-offs exist between the different methods. Using a cost-utility analysis approach, our aim was to identify the most cost-effective form of treatment for managing Dupuytren’s contracture it and the threshold at which collagenase is cost-effective. We developed an expected-value decision analysis model for Dupuytren’s contracture affecting a single finger, comparing the cost-effectiveness of fasciectomy, aponeurotomy and collagenase from a societal perspective. Cost-effectiveness, one-way sensitivity and variability analyses were performed using standard thresholds for cost effective treatment ($50 000 to $100 000/QALY gained). Percutaneous needle aponeurotomy was the preferred strategy for managing contractures affecting a single finger. The cost-effectiveness of primary aponeurotomy improved when repeated to treat recurrence. Fasciectomy was not cost-effective. Collagenase was cost-effective relative to and preferred over aponeurotomy at $875 and $470 per course of treatment, respectively.

In summary, our model supports the trend towards non-surgical interventions for managing Dupuytren’s contracture affecting a single finger. Injectable collagenase will only be feasible in our publicly funded healthcare system if it costs significantly less than current United States pricing.

Cite this article: Bone Joint J 2013;95-B:1094–1100.