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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. Results. A total of 53 patients were deemed eligible, and 50 patients (94%) recruited between April 2022 and October 2022. Overall, 49 patients (98%) complied with treatment. Outcome data were collected in 100% of participants at three months and 94% at six months. There were no significant adverse events. Both groups demonstrated improvement in patient-reported outcome measures over the six-month period. Conclusion. Our study shows that it is feasible to recruit to a patient-blinded randomized controlled trial comparing APS and CSI for subacromial pain in terms of clinical outcomes and health-resource use in the UK. Safety and efficacy data are presented. Cite this article: Bone Jt Open 2024;5(7):534–542


Bone & Joint Research
Vol. 13, Issue 8 | Pages 392 - 400
5 Aug 2024
Barakat A Evans J Gibbons C Singh HP

Aims. The Oxford Shoulder Score (OSS) is a 12-item measure commonly used for the assessment of shoulder surgeries. This study explores whether computerized adaptive testing (CAT) provides a shortened, individually tailored questionnaire while maintaining test accuracy. Methods. A total of 16,238 preoperative OSS were available in the National Joint Registry (NJR) for England, Wales, Northern Ireland, the Isle of Man, and the States of Guernsey dataset (April 2012 to April 2022). Prior to CAT, the foundational item response theory (IRT) assumptions of unidimensionality, monotonicity, and local independence were established. CAT compared sequential item selection with stopping criteria set at standard error (SE) < 0.32 and SE < 0.45 (equivalent to reliability coefficients of 0.90 and 0.80) to full-length patient-reported outcome measure (PROM) precision. Results. Confirmatory factor analysis (CFA) for unidimensionality exhibited satisfactory fit with root mean square standardized residual (RSMSR) of 0.06 (cut-off ≤ 0.08) but not with comparative fit index (CFI) of 0.85 or Tucker-Lewis index (TLI) of 0.82 (cut-off > 0.90). Monotonicity, measured by H value, yielded 0.482, signifying good monotonic trends. Local independence was generally met, with Yen’s Q3 statistic > 0.2 for most items. The median item count for completing the CAT simulation with a SE of 0.32 was 3 (IQR 3 to 12), while for a SE of 0.45 it was 2 (IQR 2 to 6). This constituted only 25% and 16%, respectively, when compared to the 12-item full-length questionnaire. Conclusion. Calibrating IRT for the OSS has resulted in the development of an efficient and shortened CAT while maintaining accuracy and reliability. Through the reduction of redundant items and implementation of a standardized measurement scale, our study highlights a promising approach to alleviate time burden and potentially enhance compliance with these widely used outcome measures. Cite this article: Bone Joint Res 2024;13(8):392–400


Bone & Joint Open
Vol. 3, Issue 10 | Pages 815 - 825
20 Oct 2022
Athanatos L Kulkarni K Tunnicliffe H Samaras M Singh HP Armstrong AL

Aims

There remains a lack of consensus regarding the management of chronic anterior sternoclavicular joint (SCJ) instability. This study aimed to assess whether a standardized treatment algorithm (incorporating physiotherapy and surgery and based on the presence of trauma) could successfully guide management and reduce the number needing surgery.

Methods

Patients with chronic anterior SCJ instability managed between April 2007 and April 2019 with a standardized treatment algorithm were divided into non-traumatic (offered physiotherapy) and traumatic (offered surgery) groups and evaluated at discharge. Subsequently, midterm outcomes were assessed via a postal questionnaire with a subjective SCJ stability score, Oxford Shoulder Instability Score (OSIS, adapted for the SCJ), and pain visual analogue scale (VAS), with analysis on an intention-to-treat basis.


Bone & Joint Open
Vol. 4, Issue 3 | Pages 205 - 209
16 Mar 2023
Jump CM Mati W Maley A Taylor R Gratrix K Blundell C Lane S Solanki N Khan M Choudhry M Shetty V Malik RA Charalambous CP

Aims

Frozen shoulder is a common, painful condition that results in impairment of function. Corticosteroid injections are commonly used for frozen shoulder and can be given as glenohumeral joint (GHJ) injection or suprascapular nerve block (SSNB). Both injection types have been shown to significantly improve shoulder pain and range of motion. It is not currently known which is superior in terms of relieving patients’ symptoms. This is the protocol for a randomized clinical trial to investigate the clinical effectiveness of corticosteroid injection given as either a GHJ injection or SSNB.

Methods

The Therapeutic Injections For Frozen Shoulder (TIFFS) study is a single centre, parallel, two-arm, randomized clinical trial. Participants will be allocated on a 1:1 basis to either a GHJ corticosteroid injection or SSNB. Participants in both trial arms will then receive physiotherapy as normal for frozen shoulder. The primary analysis will compare the Oxford Shoulder Score (OSS) at three months after injection. Secondary outcomes include OSS at six and 12 months, range of shoulder movement at three months, and Numeric Pain Rating Scale, abbreviated Disabilities of Arm, Shoulder and Hand score, and EuroQol five-level five-dimension health index at three months, six months, and one year after injection. A minimum of 40 patients will be recruited to obtain 80% power to detect a minimally important difference of ten points on the OSS between the groups at three months after injection. The study is registered under ClinicalTrials.gov with the identifier NCT04965376.


Bone & Joint Open
Vol. 5, Issue 9 | Pages 793 - 799
20 Sep 2024
Cederqvist S Flinkkilä T Tuominen A Sormaala M Ylinen J Kautiainen H Sirniö K Pamilo K Kiviranta I Paloneva J

Aims

Rotator cuff disease (RCD) can considerably decrease quality of life. Here, we investigated whether health-related quality of life (HRQoL) influences the need for surgery in patients with RCD.

Methods

We performed an analysis of 417 patients with symptomatic RCD who were recruited from two hospitals between June 2008 and December 2014 to be randomized to receive non-surgical or surgical treatment. After a three-month rehabilitation period, 36-Item Short-Form Health Survey questionnaire (SF-36), shoulder pain (visual analogue scale (VAS)), and shoulder function (Constant-Murley score) data were available from 191 still-symptomatic patients who were eligible for surgery. A control group was formed from 87 excluded patients who were no longer eligible for surgery due to relief of symptoms.


Bone & Joint Open
Vol. 3, Issue 11 | Pages 850 - 858
2 Nov 2022
Khoriati A Fozo ZA Al-Hilfi L Tennent D

Aims

The management of mid-shaft clavicle fractures (MSCFs) has evolved over the last three decades. Controversy exists over which specific fracture patterns to treat and when. This review aims to synthesize the literature in order to formulate an appropriate management algorithm for these injuries in both adolescents and adults.

Methods

This is a systematic review of clinical studies comparing the outcomes of operative and nonoperative treatments for MSCFs in the past 15 years. The literature was searched using, PubMed, Google scholar, OVID Medline, and Embase. All databases were searched with identical search terms: mid-shaft clavicle fractures (± fixation) (± nonoperative).


Aims

To report early (two-year) postoperative findings from a randomized controlled trial (RCT) investigating disease-specific quality of life (QOL), clinical, patient-reported, and radiological outcomes in patients undergoing a total shoulder arthroplasty (TSA) with a second-generation uncemented trabecular metal (TM) glenoid versus a cemented polyethylene glenoid (POLY) component.

Methods

Five fellowship-trained surgeons from three centres participated. Patients aged between 18 and 79 years with a primary diagnosis of glenohumeral osteoarthritis were screened for eligibility. Patients were randomized intraoperatively to either a TM or POLY glenoid component. Study intervals were: baseline, six weeks, six-, 12-, and 24 months postoperatively. The primary outcome was the Western Ontario Osteoarthritis Shoulder QOL score. Radiological images were reviewed for metal debris. Mixed effects repeated measures analysis of variance for within and between group comparisons were performed.


Bone & Joint Open
Vol. 2, Issue 9 | Pages 773 - 784
1 Sep 2021
Rex SS Kottam L McDaid C Brealey S Dias J Hewitt CE Keding A Lamb SE Wright K Rangan A

Aims

This systematic review places a recently completed multicentre randomized controlled trial (RCT), UK FROST, in the context of existing randomized evidence for the management of primary frozen shoulder. UK FROST compared the effectiveness of pre-specified physiotherapy techniques with a steroid injection (PTSI), manipulation under anaesthesia (MUA) with a steroid injection, and arthroscopic capsular release (ACR). This review updates a 2012 review focusing on the effectiveness of MUA, ACR, hydrodilatation, and PTSI.

Methods

MEDLINE, Embase, PEDro, Science Citation Index, Clinicaltrials.gov, CENTRAL, and the World Health Organization (WHO) International Clinical Trials Registry were searched up to December 2018. Reference lists of included studies were screened. No language restrictions applied. Eligible studies were RCTs comparing the effectiveness of MUA, ACR, PTSI, and hydrodilatation against each other, or supportive care or no treatment, for the management of primary frozen shoulder.


Bone & Joint Open
Vol. 2, Issue 1 | Pages 58 - 65
22 Jan 2021
Karssiens TJ Gill JR Sunil Kumar KH Sjolin SU

Aims

The Mathys Affinis Short is the most frequently used stemless total shoulder prosthesis in the UK. The purpose of this prospective cohort study is to report the survivorship, clinical, and radiological outcomes of the first independent series of the Affinis Short prosthesis.

Methods

From January 2011 to January 2019, a total of 141 Affinis Short prostheses were implanted in 127 patients by a single surgeon. Mean age at time of surgery was 68 (44 to 89). Minimum one year and maximum eight year follow-up (mean 3.7 years) was analyzed using the Oxford Shoulder Score (OSS) at latest follow-up. Kaplan-Meier survivorship analysis was performed with implant revision as the endpoint. Most recently performed radiographs were reviewed for component radiolucent lines (RLLs) and proximal humeral migration.


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.