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Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_15 | Pages 37 - 37
7 Aug 2024
Wilson M Cole A Hewson D Hind D Hawksworth O Hyslop M Keetharuth A Macfarlane A Martin B McLeod G Rombach I Swaby L Tripathi S Wilby M
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Background

Over 55,000 spinal operations are performed annually in the NHS. Effective postoperative analgesia facilitates early mobilisation and assists rehabilitation and hospital discharge, but is difficult to achieve with conventional, opioid-based, oral analgesia. The clinical and cost-effectiveness of two alternative techniques, namely intrathecal opioid and the more novel erector-spinae plane blockade, is unknown. The Pain Relief After Instrumented Spinal Surgery (PRAISE) trial aims to evaluate these techniques.

Methods

PRAISE is a multicentre, prospective, parallel group, patient-blinded, randomised trial, seeking to recruit 456 adult participants undergoing elective, posterior lumbar-instrumented spinal surgery from up to 25 NHS hospitals. Participants will be randomised 1:1:1 to receive (1) Usual Care with local wound infiltration, (2) Intrathecal Opioid plus Usual Care with local wound infiltration or (3) Erector Spinae Plane blockade plus Usual Care with no local wound infiltration. The primary outcome is pain on movement on a 100mm visual analogue scale at 24 hours post-surgery. Secondary outcomes include pain at rest, leg pain, quality of recovery (QoR-15), postoperative opioid consumption, time to mobilisation, length of hospital stay, health utility (EQ-5D-5L), adverse events and resource use. Parallel economic evaluation will estimate incremental cost-effectiveness ratios.


Bone & Joint Open
Vol. 5, Issue 7 | Pages 534 - 542
1 Jul 2024
Woods A Howard A Peckham N Rombach I Saleh A Achten J Appelbe D Thamattore P Gwilym SE

Aims

The primary aim of this study was to assess the feasibility of recruiting and retaining patients to a patient-blinded randomized controlled trial comparing corticosteroid injection (CSI) to autologous protein solution (APS) injection for the treatment of subacromial shoulder pain in a community care setting. The study focused on recruitment rates and retention of participants throughout, and collected data on the interventions’ safety and efficacy.

Methods

Participants were recruited from two community musculoskeletal treatment centres in the UK. Patients were eligible if aged 18 years or older, and had a clinical diagnosis of subacromial impingement syndrome which the treating clinician thought was suitable for treatment with a subacromial injection. Consenting patients were randomly allocated 1:1 to a patient-blinded subacromial injection of CSI (standard care) or APS. The primary outcome measures of this study relate to rates of recruitment, retention, and compliance with intervention and follow-up to determine feasibility. Secondary outcome measures relate to the safety and efficacy of the interventions.


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_6 | Pages 46 - 46
2 May 2024
Palmer A Fernquest S Logishetty K Rombach I Harin A Mansour R Dijkstra P Andrade T Dutton S Glyn-Jones S
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The primary treatment goal for patients with femoroacetabular impingement syndrome, a common hip condition in athletes, is to improve pain and function. In selected patients, in the short term following intervention, arthroscopic hip surgery is superior to a pragmatic NHS- type physiotherapy programme. Here, we report the three-year follow-up results from the FemoroAcetabular Impingement Trial (FAIT), comparing arthroscopic hip surgery with physiotherapy in the management of patients with femoroacetabular impingement (FAI) syndrome.

Two-group parallel, assessor-blinded, pragmatic randomised controlled study across seven NHS England sites. 222 participants aged 18 to 60 years with FAI syndrome confirmed clinically and radiologically were randomised (1:1) to receive arthroscopic hip surgery (n = 112) or physiotherapy and activity modification (n = 110). We previously reported on the hip outcome score at eight months. The primary outcome measure of this study was minimum Joint Space Width (mJSW) on Anteroposterior Radiograph at 38 months post randomisation. Secondary outcome measures included the Hip Outcome Score and Scoring Hip Osteoarthritis with MRI (SHOMRI) score.

Minimum Joint Space Width data were available for 101 participants (45%) at 38 months post randomisation. Hip outcome score and MRI data were available for 77% and 62% of participants respectively. mJSW was higher in the arthroscopy group (mean (SD) 3.34mm (1.01)) compared to the physiotherapy group (2.99mm (1.33)) at 38 months, p=0.017, however this did not exceed the minimally clinically important difference of 0.48mm. SHOMRI score was significantly lower in the arthroscopy group (mean (SD) 9.22 (11.43)) compared to the physiotherapy group (22.76 (15.26)), p-value <0.001. Hip outcome score was higher in the arthroscopy group (mean (SD) 84.2 (17.4)) compared with the physiotherapy group (74.2 (21.9)), p-value < 0.001).

Patients with FAI syndrome treated surgically may experience slowing of osteoarthritisprogression and superior pain and function compared with patients treated non- operatively.


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.


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_7 | Pages 6 - 6
1 Jul 2022
Hamilton T Knight R Stokes J Rombach I Cooper C Davies L Dutton S Barker K Cook J Lamb S Murray D Poulton L Wang A Strickland L Duren BV Leal J Beard D Pandit H
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Abstract

Introduction

This multi-centre randomised controlled trial evaluated the clinical and cost effectiveness of liposomal bupivacaine for pain and recovery following knee replacement.

Methodology

533patients undergoing primary knee replacement were randomised to receive either liposomal bupivacaine (266mg) plus bupivacaine hydrochloride (100mg) or control (bupivacaine hydrochloride 100mg), administered at the surgical site. The co-primary outcomes were pain visual analogue score (VAS) area under the curve (AUC) 6 to 72hours and the Quality of Recovery 40 (QoR-40) score at 72hours.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_14 | Pages 60 - 60
1 Dec 2019
Hotchen A Dudareva M Ferguson J Rombach I Scarborough M McNally M
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Aim

Bone and joint infections are a serious complication of trauma, surgery and soft tissue infections. However, there are few data presenting patient reported outcome measures for osteomyelitis. A recently proposed method for classification of osteomyelitis, BACH, stratifies patients into ‘uncomplicated’ and ‘complex’, based on four key inter-disciplinary components: Bone involvement, Anti-microbial options, soft-tissue Coverage and Host status. We aim to correlate the classification severity with patient reported outcomes following osteomyelitis surgery.

Method

Seventy-one patients with long-bone osteomyelitis, confirmed using a validated composite protocol, were included. Patients received a single-stage procedure at a specialist bone infection unit. Euro-Qol EQ-5D-3L questionnaires and Visual Analogue Scores (VAS) (0–100) were collected prospectively at baseline, 14 days, 6 weeks, 4 months and 1 year post-operatively. The EQ-5D-3L index score, a composite measure of performance of daily activities, was calculated from the 5 domains of the EQ-5D-3L. BACH was applied retrospectively by two independent clinicians blinded to all patient outcomes.


The Bone & Joint Journal
Vol. 101-B, Issue 1 | Pages 55 - 62
1 Jan 2019
Rombach I Merritt N Shirkey BA Rees JL Cook JA Cooper C Carr AJ Beard DJ Gray AM

Aims

The aims of this study were to compare the use of resources, costs, and quality of life outcomes associated with subacromial decompression, arthroscopy only (placebo surgery), and no treatment for subacromial pain in the United Kingdom National Health Service (NHS), and to estimate their cost-effectiveness.

Patients and Methods

The use of resources, costs, and quality-adjusted life-years (QALYs) were assessed in the trial at six months and one year. Results were extrapolated to two years after randomization. Differences between treatment arms, based on the intention-to-treat principle, were adjusted for covariates and missing data were handled using multiple imputation. Incremental cost-effectiveness ratios were calculated, with uncertainty around the values estimated using bootstrapping.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_22 | Pages 9 - 9
1 Dec 2017
Li HK Rombach I Zambellas R Warren S Mack D Hopkins S Hems-ley C Atkins B Rogers M McNally M Scarborough M
Full Access

Aim

Management of bone and joint infection can be technically complex and often requires a prolonged course of antibiotics. Traditionally, bone and joint infection management utilises nurse-led outpatient parenteral antibiotic therapy (OPAT) where adherence is unlikely to be an issue. However, with increasing evidence in favour of oral therapy, the question of adherence merits further consideration. We describe the adherence of both oral (PO) and self-administered intravenous (IV) antibiotics in the treatment of bone and joint infection using paper questionnaires (8-item Modified Morisky Adherence Score (MMAS)) and, in a subset of participants, electronic pill containers (Medication Event Monitoring Systems*).

Method

All eligible participants enrolled in the OVIVA trial (2010–2015) were randomised to six weeks of either PO or IV antibiotic treatment arms. Self-administering patients were followed up with questionnaires at day 14 and 42. A subset of PO participants was also given the medication event monitoring system* in order to validate the adherence questionnaires. The results were correlated with treatment failures at one-year follow-up.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_22 | Pages 42 - 42
1 Dec 2017
Scarborough M Li HK Rombach I Zambellas R Walker S Kumin M Lipsky BA Hughes H Bose D Warren S Geue C McMeekin N Woodhouse A Atkins B McNally M Berendt T Angus B Byren I Thwaites G Bejon P
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Aim

Current standard of care in the management of bone and joint infection commonly includes a 4–6 week course of intravenous (IV) antibiotics but there is little evidence to suggest that oral antibiotic therapy results in worse outcomes. The primary objective was to determine whether oral antibiotics are non-inferior to IV antibiotics in this setting.

Method

This was a parallel group, randomised (1:1), open label, non-inferiority trial across twenty-six NHS hospitals in the United Kingdom. Eligible patients were adults with a clinical diagnosis of bone, joint or orthopaedic metalware-associated infection who would ordinarily receive at least six weeks of antibiotics and who had received ≤7 days of IV therapy from the date of definitive surgery (or the start of planned curative treatment in patients managed non-operatively). Participants were randomised to receive either oral or IV antibiotics for the first 6 weeks of therapy. Follow-on oral therapy was permitted in either arm. The primary outcome was the proportion of participants experiencing definitive treatment failure within one year of randomisation. The non-inferiority margin was set at 7.5%.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_22 | Pages 43 - 43
1 Dec 2017
Alvand A Li HK Rombach I Zambellas R Kendrick B Taylor A Atkins B Bejon P McNally M Scarborough M
Full Access

Aim

To assess the influence of route of antibiotic administration on patient-reported outcome measures (PROMS) of individuals treated for hip and knee infections in the OVIVA multi-centre randomised controlled trial.

Method

This study was designed to determine whether oral antibiotic therapy is non-inferior to intravenous (IV) therapy when given for the first six weeks of treatment for bone and joint infections. Of the 1054 participants recruited from 26 centres, 462 were treated for periprosthetic or native joint infections of the hip or knee. There were 243 participants in the IV antibiotic cohort and 219 in the oral cohort. Functional outcome was determined at baseline through to one year using the Oxford Hip/Knee Score (OHS/OKS) as joint-specific measures (0 the worse and 48 the best). An adjusted quantile regression model was used to compare functional outcome scores.


The Bone & Joint Journal
Vol. 98-B, Issue 10_Supple_B | Pages 22 - 27
1 Oct 2016
Bottomley N Jones LD Rout R Alvand A Rombach I Evans T Jackson WFM Beard DJ Price AJ

Aims

The aim of this to study was to compare the previously unreported long-term survival outcome of the Oxford medial unicompartmental knee arthroplasty (UKA) performed by trainee surgeons and consultants.

Patients and Methods

We therefore identified a previously unreported cohort of 1084 knees in 947 patients who had a UKA inserted for anteromedial knee arthritis by consultants and surgeons in training, at a tertiary arthroplasty centre and performed survival analysis on the group with revision as the endpoint.


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. 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).