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Bone & Joint Open
Vol. 5, Issue 4 | Pages 343 - 349
22 Apr 2024
Franssen M Achten J Appelbe D Costa ML Dutton S Mason J Gould J Gray A Rangan A Sheehan W Singh H Gwilym SE

Aims

Fractures of the humeral shaft represent 3% to 5% of all fractures. The most common treatment for isolated humeral diaphysis fractures in the UK is non-operative using functional bracing, which carries a low risk of complications, but is associated with a longer healing time and a greater risk of nonunion than surgery. There is an increasing trend to surgical treatment, which may lead to quicker functional recovery and lower rates of fracture nonunion than functional bracing. However, surgery carries inherent risk, including infection, bleeding, and nerve damage. The aim of this trial is to evaluate the clinical and cost-effectiveness of functional bracing compared to surgical fixation for the treatment of humeral shaft fractures.

Methods

The HUmeral SHaft (HUSH) fracture study is a multicentre, prospective randomized superiority trial of surgical versus non-surgical interventions for humeral shaft fractures in adult patients. Participants will be randomized to receive either functional bracing or surgery. With 334 participants, the trial will have 90% power to detect a clinically important difference for the Disabilities of the Arm, Shoulder and Hand questionnaire score, assuming 20% loss to follow-up. Secondary outcomes will include function, pain, quality of life, complications, cost-effectiveness, time off work, and ability to drive.


Bone & Joint Open
Vol. 3, Issue 11 | Pages 898 - 906
15 Nov 2022
Dakin H Rombach I Dritsaki M Gray A Ball C Lamb SE Nanchahal J

Aims

To estimate the potential cost-effectiveness of adalimumab compared with standard care alone for the treatment of early-stage Dupuytren’s disease (DD) and the value of further research from an NHS perspective.

Methods

We used data from the Repurposing anti-TNF for Dupuytren’s disease (RIDD) randomized controlled trial of intranodular adalimumab injections in patients with early-stage progressive DD. RIDD found that intranodular adalimumab injections reduced nodule hardness and size in patients with early-stage DD, indicating the potential to control disease progression. A within-trial cost-utility analysis compared four adalimumab injections with no further treatment against standard care alone, taking a 12-month time horizon and using prospective data on EuroQol five-dimension five-level questionnaire (EQ-5D-5L) and resource use from the RIDD trial. We also developed a patient-level simulation model similar to a Markov model to extrapolate trial outcomes over a lifetime using data from the RIDD trial and a literature review. This also evaluated repeated courses of adalimumab each time the nodule reactivated (every three years) in patients who initially responded.


Bone & Joint Open
Vol. 3, Issue 10 | Pages 746 - 752
1 Oct 2022
Hadfield JN Omogbehin TS Brookes C Walker R Trompeter A Bretherton CP Gray A Eardley WGP

Aims

Understanding of open fracture management is skewed due to reliance on small-number lower limb, specialist unit reports and large, unfocused registry data collections. To address this, we carried out the Open Fracture Patient Evaluation Nationwide (OPEN) study, and report the demographic details and the initial steps of care for patients admitted with open fractures in the UK.

Methods

Any patient admitted to hospital with an open fracture between 1 June 2021 and 30 September 2021 was included, excluding phalanges and isolated hand injuries. Institutional information governance approval was obtained at the lead site and all data entered using Research Electronic Data Capture. Demographic details, injury, fracture classification, and patient dispersal were detailed.


The Bone & Joint Journal
Vol. 102-B, Issue 7 | Pages 950 - 958
1 Jul 2020
Dakin H Eibich P Beard D Gray A Price A

Aims

To assess how the cost-effectiveness of total hip arthroplasty (THA) and total knee arthroplasty (TKA) varies with age, sex, and preoperative Oxford Hip or Knee Score (OHS/OKS); and to identify the patient groups for whom THA/TKA is cost-effective.

Methods

We conducted a cost-effectiveness analysis using a Markov model from a United Kingdom NHS perspective, informed by published analyses of patient-level data. We assessed the cost-effectiveness of THA and TKA in adults with hip or knee osteoarthritis compared with having no arthroplasty surgery during the ten-year time horizon.


The Bone & Joint Journal
Vol. 99-B, Issue 1 | Pages 107 - 115
1 Jan 2017
Carr A Cooper C Campbell MK Rees J Moser J Beard DJ Fitzpatrick R Gray A Dawson J Murphy J Bruhn H Cooper D Ramsay C

Aims

The appropriate management for patients with a degenerative tear of the rotator cuff remains controversial, but operative treatment, particularly arthroscopic surgery, is increasingly being used. Our aim in this paper was to compare the effectiveness of arthroscopic with open repair of the rotator cuff.

Patients and Methods

A total of 273 patients were recruited to a randomised comparison trial (136 to arthroscopic surgery and 137 to open surgery) from 19 teaching and general hospitals in the United Kingdom. The surgeons used their usual preferred method of repair. The Oxford Shoulder Score (OSS), two years post-operatively, was the primary outcome measure. Imaging of the shoulder was performed at one year after surgery. The trial is registered with Current Controlled Trials, ISRCTN97804283.


The Bone & Joint Journal
Vol. 98-B, Issue 12 | Pages 1648 - 1655
1 Dec 2016
Murphy J Gray A Cooper C Cooper D Ramsay C Carr A

Aims

A trial-based comparison of the use of resources, costs and quality of life outcomes of arthroscopic and open surgical management for rotator cuff tears in the United Kingdom NHS was performed using data from the United Kingdom Rotator Cuff Study (UKUFF) randomised controlled trial.

Patients and Methods

Using data from 273 patients, healthcare-related use of resources, costs and quality-adjusted life years (QALYs) were estimated at 12 months and 24 months after surgery on an intention-to-treat basis with adjustment for covariates. Uncertainty about the incremental cost-effectiveness ratio for arthroscopic versus open management at 24 months of follow-up was incorporated using bootstrapping. Multiple imputation methods were used to deal with missing data.


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.


The Bone & Joint Journal
Vol. 95-B, Issue 4 | Pages 486 - 492
1 Apr 2013
Breeman S Campbell MK Dakin H Fiddian N Fitzpatrick R Grant A Gray A Johnston L MacLennan GS Morris RW Murray DW

There is conflicting evidence about the merits of mobile bearings in total knee replacement, partly because most randomised controlled trials (RCTs) have not been adequately powered. We report the results of a multicentre RCT of mobile versus fixed bearings. This was part of the knee arthroplasty trial (KAT), where 539 patients were randomly allocated to mobile or fixed bearings and analysed on an intention-to-treat basis. The primary outcome measure was the Oxford Knee Score (OKS) plus secondary measures including Short Form-12, EuroQol EQ-5D, costs, cost-effectiveness and need for further surgery.

There was no significant difference between the groups pre-operatively: mean OKS was 17.18 (sd 7.60) in the mobile-bearing group and 16.49 (sd 7.40) in the fixed-bearing group. At five years mean OKS was 33.19 (sd 16.68) and 33.65 (sd 9.68), respectively. There was no significant difference between trial groups in OKS at five years (-1.12 (95% confidence interval -2.77 to 0.52) or any of the other outcome measures. Furthermore, there was no significant difference in the proportion of patients with knee-related re-operations or in total costs.

In this appropriately powered RCT, over the first five years after total knee replacement functional outcomes, re-operation rates and healthcare costs appear to be the same irrespective of whether a mobile or fixed bearing is used.

Cite this article: Bone Joint J 2013;95-B:486–92.


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 7 | Pages 961 - 968
1 Jul 2012
Duckworth AD Buijze GA Moran M Gray A Court-Brown CM Ring D McQueen MM

A prospective study was performed to develop a clinical prediction rule that incorporated demographic and clinical factors predictive of a fracture of the scaphoid. Of 260 consecutive patients with a clinically suspected or radiologically confirmed scaphoid fracture, 223 returned for evaluation two weeks after injury and formed the basis of our analysis. Patients were evaluated within 72 hours of injury and at approximately two and six weeks after injury using clinical assessment and standard radiographs. Demographic data and the results of seven specific tests in the clinical examination were recorded.

There were 116 (52%) men and their mean age was 33 years (13 to 95; sd 17.9). In 62 patients (28%) a scaphoid fracture was confirmed. A logistic regression model identified male gender (p = 0.002), sports injury (p = 0.004), anatomical snuff box pain on ulnar deviation of the wrist within 72 hours of injury (p < 0.001), and scaphoid tubercle tenderness at two weeks (p < 0.001) as independent predictors of fracture. All patients with no pain at the anatomical snuff box on ulnar deviation of the wrist within 72 hours of injury did not have a fracture (n = 72, 32%). With four independently significant factors positive, the risk of fracture was 91%.

Our study has demonstrated that clinical prediction rules have a considerable influence on the probability of a suspected scaphoid fracture. This will help improve the use of supplementary investigations where the diagnosis remains in doubt.


The Journal of Bone & Joint Surgery British Volume
Vol. 82-B, Issue 1 | Pages 2 - 8
1 Jan 2000
Maniadakis N Gray A

It is becoming widely accepted that research which considers only the outcome and not the costs associated with new technologies in health care, is of limited value in making decisions about the use of scarce resources. Economic evaluation is becoming a standard feature of clinical research but many published economic evaluations fall short of best practice in their methodology. We have described the essential features of economic evaluation, using published studies in orthopaedics, in order to try to improve the ability of orthopaedic surgeons to read, understand and appraise such studies critically, and to encourage them to consider including economic evaluation in future investigations.


The Journal of Bone & Joint Surgery British Volume
Vol. 76-B, Issue 2 | Pages 193 - 197
1 Mar 1994
Dandy D Gray A

We describe 129 patients with disabling instability of the knee due to deficiency of the anterior cruciate ligament. They were treated by replacement of the ligament with a Leeds-Keio prosthesis supplemented by an extra-articular MacIntosh lateral substitution reconstruction. After an average period of 71 months a satisfactory outcome was found in only 60% of knees. Nine had required revision because of recurrent instability and the pivot-shift sign had become positive in 40% of patients. In our opinion the long-term results are unsatisfactory when compared with those obtained using a graft from the medial third of the patellar tendon supplemented with a MacIntosh extra-articular tenodesis.


The Journal of Bone & Joint Surgery British Volume
Vol. 73-B, Issue 1 | Pages 25 - 28
1 Jan 1991
Lalor P Revell P Gray A Wright S Railton G Freeman M

Tissues from five patients who underwent revision operations for failed total hip replacements were found to contain large quantities of particulate titanium. In four cases this metal must have come from titanium alloy screws used to fix the acetabular component; in the fifth case it may also have originated from a titanium alloy femoral head. Monoclonal antibody labelling showed abundant macrophages and T-lymphocytes, in the absence of B-lymphocytes, suggesting sensitisation to titanium. Skin patch testing with dilute solutions of titanium salts gave negative results in all five patients. However, two of them had a positive skin test to a titanium-containing ointment.