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The Bone & Joint Journal
Vol. 98-B, Issue 2 | Pages 147 - 151
1 Feb 2016
Haddad FS McLawhorn AS

Health economic evaluations potentially provide valuable information to clinicians, health care administrators, and policy makers regarding the financial implications of decisions about the care of patients. The highest quality research should be used to inform decisions that have direct impact on the access to care and the outcome of treatment. However, economic analyses are often complex and use research methods which are relatively unfamiliar to clinicians. Furthermore, health economic data have substantial national, regional, and institutional variability, which can limit the external validity of the results of a study. Therefore, minimum guidelines that aim to standardise the quality and transparency of reporting health economic research have been developed, and instruments are available to assist in the assessment of its quality and the interpretation of results.

The purpose of this editorial is to discuss the principal types of health economic studies, to review the most common instruments for judging the quality of these studies and to describe current reporting guidelines. Recommendations for the submission of these types of studies to The Bone & Joint Journal are provided.

Cite this article: Bone Joint J 2016;98-B:147–51.


Bone & Joint 360
Vol. 4, Issue 5 | Pages 32 - 33
1 Oct 2015
Das A


Bone & Joint Research
Vol. 4, Issue 12 | Pages 190 - 194
1 Dec 2015
Kleinlugtenbelt YV Hoekstra M Ham SJ Kloen P Haverlag R Simons MP Bhandari M Goslings JC Poolman RW Scholtes VAB

Objectives

Current studies on the additional benefit of using computed tomography (CT) in order to evaluate the surgeons’ agreement on treatment plans for fracture are inconsistent. This inconsistency can be explained by a methodological phenomenon called ‘spectrum bias’, defined as the bias inherent when investigators choose a population lacking therapeutic uncertainty for evaluation. The aim of the study is to determine the influence of spectrum bias on the intra-observer agreement of treatment plans for fractures of the distal radius.

Methods

Four surgeons evaluated 51 patients with displaced fractures of the distal radius at four time points: T1 and T2: conventional radiographs; T3 and T4: radiographs and additional CT scan (radiograph and CT). Choice of treatment plan (operative or non-operative) and therapeutic certainty (five-point scale: very uncertain to very certain) were rated. To determine the influence of spectrum bias, the intra-observer agreement was analysed, using Kappa statistics, for each degree of therapeutic certainty.


The Bone & Joint Journal
Vol. 97-B, Issue 9 | Pages 1250 - 1256
1 Sep 2015
Agrawal Y Russon K Chakrabarti I Kocheta A

Wrist block has been used to provide pain relief for many procedures on the hand and wrist but its role in arthroscopy of the wrist remains unexplored. Chondrotoxicity has been a concern with the intra-articular infiltration of local anaesthetic. We aimed to evaluate and compare the analgesic effect of portal and wrist joint infiltration with a wrist block on the pain experienced by patients after arthroscopy of the wrist.

A prospective, randomised, double-blind trial was designed and patients undergoing arthroscopy of the wrist under general anaesthesia as a day case were recruited for the study. Levo-bupivacaine was used for both techniques. The effects were evaluated using a ten-point visual analogue scale, and the use of analgesic agents was also compared. The primary outcomes for statistical analyses were the mean pain scores and the use of analgesia post-operatively.

A total of 34 patients (63% females) were recruited to the portal and joint infiltration group and 32 patients (59% males) to the wrist block group. Mean age was 40.8 years in the first group and 39.7 years in the second group (p > 0.05). Both techniques provided effective pain relief in the first hour and 24 hours post-operatively but wrist block gave better pain scores at bedtime on the day of surgery (p = 0.007) and at 24 hours post-operatively (p = 0.006).

Wrist block provides better and more reliable analgesia in patients undergoing arthroscopy of the wrist without exposing patients to the risk of chondrotoxicity.

Cite this article: Bone Joint J 2015;97-B:1250–6.


The Bone & Joint Journal
Vol. 97-B, Issue 7 | Pages 957 - 962
1 Jul 2015
Yamazaki H Uchiyama S Komatsu M Hashimoto S Kobayashi Y Sakurai T Kato H

There is no consensus on the benefit of arthroscopically assisted reduction of the articular surface combined with fixation using a volar locking plate for the treatment of intra-articular distal radial fractures. In this study we compared the functional and radiographic outcomes of fluoroscopically and arthroscopically guided reduction of these fractures.

Between February 2009 and May 2013, 74 patients with unilateral unstable intra-articular distal radial fractures were randomised equally into the two groups for treatment. The mean age of these 74 patients was 64 years (24 to 92). We compared functional outcomes including active range of movement of the wrist, grip strength and Disabilities of the Arm, Shoulder, and Hand scores at six and 48 weeks; and radiographic outcomes that included gap, step, radial inclination, volar angulation and ulnar variance.

There were no significant differences between the techniques with regard to functional outcomes or radiographic parameters. The mean gap and step in the fluoroscopic and arthroscopic groups were comparable at 0.9 mm (standard deviation (sd) 0.7) and 0.7 mm (sd 0.7) and 0.6 mm (sd 0.6) and 0.4 mm (sd 0.5), respectively; p = 0.18 and p = 0.35).

Arthroscopic reduction conferred no advantage over conventional fluoroscopic guidance in achieving anatomical reduction of intra-articular distal radial fractures when using a volar locking plate.

Cite this article: Bone Joint J 2015; 97-B:957–62.


The Bone & Joint Journal
Vol. 97-B, Issue 9 | Pages 1264 - 1270
1 Sep 2015
Karantana A Scammell BE Davis TRC Whynes DK

This study compares the cost-effectiveness of treating dorsally displaced distal radial fractures with a volar locking plate and percutaneous fixation. It was performed from the perspective of the National Health Service (NHS) using data from a single-centre randomised controlled trial. In total 130 patients (18 to 73 years of age) with a dorsally displaced distal radial fracture were randomised to treatment with either a volar locking plate (n = 66) or percutaneous fixation (n = 64). The methodology was according to National Institute for Health and Care Excellence guidance for technology appraisals. .

There were no significant differences in quality of life scores between groups at any time point in the study. Both groups returned to baseline one year post-operatively.

NHS costs for the plate group were significantly higher (p < 0.001, 95% confidence interval 497 to 930). For an additional £713, fixation with a volar locking plate offered 0.0178 additional quality-adjusted life years in the year after surgery. The incremental cost-effectiveness ratio (ICER) for plate fixation relative to percutaneous fixation at list price was £40 068. When adjusting the prices of the implants for a 20% hospital discount, the ICER was £31 898. Patients who underwent plate fixation did not return to work earlier.

We found no evidence to support the cost-effectiveness, from the perspective of the NHS, of fixation using a volar locking plate over percutaneous fixation for the operative treatment of a dorsally displaced radial fracture.

Cite this article: Bone Joint J 2015;97-B:1264–70.


The Bone & Joint Journal
Vol. 97-B, Issue 9 | Pages 1175 - 1182
1 Sep 2015
Bisseling P de Wit BWK Hol AM van Gorp MJ van Kampen A van Susante JLC

Patients from a randomised trial on resurfacing hip arthroplasty (RHA) (n = 36, 19 males; median age 57 years, 24 to 65) comparing a conventional 28 mm metal-on-metal total hip arthroplasty (MoM THA) (n = 28, 17 males; median age 59 years, 37 to 65) and a matched control group of asymptomatic patients with a 32 mm ceramic-on-polyethylene (CoP) THA (n = 33, 18 males; median age 63 years, 38 to 71) were cross-sectionally screened with metal artefact reducing sequence-MRI (MARS-MRI) for pseudotumour formation at a median of 55 months (23 to 72) post-operatively. MRIs were scored by consensus according to three different classification systems for pseudotumour formation.

Clinical scores were available for all patients and metal ion levels for MoM bearing patients.

Periprosthetic lesions with a median volume of 16 mL (1.5 to 35.9) were diagnosed in six patients in the RHA group (17%), one in the MoM THA group (4%) and six in the CoP group (18%). The classification systems revealed no clear differences between the groups. Solid lesions (n = 3) were exclusively encountered in the RHA group. Two patients in the RHA group and one in the MoM THA group underwent a revision for pseudotumour formation. There was no statistically significant relationship between clinical scoring, metal ion levels and periprosthetic lesions in any of the groups.

Periprosthetic fluid collections are seen on MARS-MRI after conventional CoP THA and RHA and may reflect a soft-tissue collection or effusion.

Currently available MRI classification systems seem to score these collections as pseudotumours, causing an-overestimatation of the incidence of pseudotumours.

Cite this article: Bone Joint J 2015;97-B:1175–82.


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. 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 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 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 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. 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.


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 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


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.