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Bone & Joint Open
Vol. 5, Issue 11 | Pages 1041 - 1048
19 Nov 2024
Delgado C Martínez-Rodríguez JM Candura D Valencia M Martínez-Catalán N Calvo E

Aims

The Bankart and Latarjet procedures are two of the most common surgical techniques to treat anterior shoulder instability with satisfactory clinical and functional outcomes. However, the outcomes in the adolescent population remain unclear, and there is no information regarding the arthroscopic Latarjet in this population. The purpose of this study was to evaluate the outcomes of the arthroscopic Bankart and arthroscopic Latarjet procedures in the management of anterior shoulder instability in adolescents.

Methods

We present a retrospective, matched-pair study of teenagers with anterior glenohumeral instability treated with an arthroscopic Bankart repair (ABR) or an arthroscopic Latarjet (AL) procedure with a minimum two-year follow-up. Preoperative demographic and clinical features, factors associated with dislocation, and complications were collected. Recurrence, defined as dislocation or subluxation, was established as the primary outcome. Clinical and functional outcomes were analyzed using objective (Rowe), and subjective (Western Ontario Shoulder Instability Index (WOSI) and Single Assessment Numeric Evaluation (SANE)) scores. Additionally, the rate of return to sport was assessed.


Bone & Joint Open
Vol. 5, Issue 10 | Pages 944 - 952
25 Oct 2024
Deveza L El Amine MA Becker AS Nolan J Hwang S Hameed M Vaynrub M

Aims. Treatment of high-grade limb bone sarcoma that invades a joint requires en bloc extra-articular excision. MRI can demonstrate joint invasion but is frequently inconclusive, and its predictive value is unknown. We evaluated the diagnostic accuracy of direct and indirect radiological signs of intra-articular tumour extension and the performance characteristics of MRI findings of intra-articular tumour extension. Methods. We performed a retrospective case-control study of patients who underwent extra-articular excision for sarcoma of the knee, hip, or shoulder from 1 June 2000 to 1 November 2020. Radiologists blinded to the pathology results evaluated preoperative MRI for three direct signs of joint invasion (capsular disruption, cortical breach, cartilage invasion) and indirect signs (e.g. joint effusion, synovial thickening). The discriminatory ability of MRI to detect intra-articular tumour extension was determined by receiver operating characteristic analysis. Results. Overall, 49 patients underwent extra-articular excision. The area under the curve (AUC) ranged from 0.65 to 0.76 for direct signs of joint invasion, and was 0.83 for all three combined. In all, 26 patients had only one to two direct signs of invasion, representing an equivocal result. In these patients, the AUC was 0.63 for joint effusion and 0.85 for synovial thickening. When direct signs and synovial thickening were combined, the AUC was 0.89. Conclusion. MRI provides excellent discrimination for determining intra-articular tumour extension when multiple direct signs of invasion are present. When MRI results are equivocal, assessment of synovial thickening increases MRI’s discriminatory ability to predict intra-articular joint extension. These results should be interpreted in the context of the study’s limitations. The inclusion of only extra-articular excisions enriched the sample for true positive cases. Direct signs likely varied with tumour histology and location. A larger, prospective study of periarticular bone sarcomas with spatial correlation of histological and radiological findings is needed to validate these results before their adoption in clinical practice. Cite this article: Bone Jt Open 2024;5(10):944–952


Bone & Joint Open
Vol. 5, Issue 10 | Pages 929 - 936
22 Oct 2024
Gutierrez-Naranjo JM Salazar LM Kanawade VA Abdel Fatah EE Mahfouz M Brady NW Dutta AK

Aims

This study aims to describe a new method that may be used as a supplement to evaluate humeral rotational alignment during intramedullary nail (IMN) insertion using the profile of the perpendicular peak of the greater tuberosity and its relation to the transepicondylar axis. We called this angle the greater tuberosity version angle (GTVA).

Methods

This study analyzed 506 cadaveric humeri of adult patients. All humeri were CT scanned using 0.625 × 0.625 × 0.625 mm cubic voxels. The images acquired were used to generate 3D surface models of the humerus. Next, 3D landmarks were automatically calculated on each 3D bone using custom-written C++ software. The anatomical landmarks analyzed were the transepicondylar axis, the humerus anatomical axis, and the peak of the perpendicular axis of the greater tuberosity. Lastly, the angle between the transepicondylar axis and the greater tuberosity axis was calculated and defined as the GTVA.


Bone & Joint Open
Vol. 5, Issue 10 | Pages 920 - 928
21 Oct 2024
Bell KR Oliver WM White TO Molyneux SG Graham C Clement ND Duckworth AD

Aims

The primary aim of this study is to quantify and compare outcomes following a dorsally displaced fracture of the distal radius in elderly patients (aged ≥ 65 years) who are managed conservatively versus with surgical fixation (open reduction and internal fixation). Secondary aims are to assess and compare upper limb-specific function, health-related quality of life, wrist pain, complications, grip strength, range of motion, radiological parameters, healthcare resource use, and cost-effectiveness between the groups.

Methods

A prospectively registered (ISRCTN95922938) randomized parallel group trial will be conducted. Elderly patients meeting the inclusion criteria with a dorsally displaced distal radius facture will be randomized (1:1 ratio) to either conservative management (cast without further manipulation) or surgery. Patients will be assessed at six, 12, 26 weeks, and 52 weeks post intervention. The primary outcome measure and endpoint will be the Patient-Rated Wrist Evaluation (PRWE) at 52 weeks. In addition, the abbreviated version of the Disabilities of Arm, Shoulder and Hand questionnaire (QuickDASH), EuroQol five-dimension questionnaire, pain score (visual analogue scale 1 to 10), complications, grip strength (dynamometer), range of motion (goniometer), and radiological assessments will be undertaken. A cost-utility analysis will be performed to assess the cost-effectiveness of surgery. We aim to recruit 89 subjects per arm (total sample size 178).


Bone & Joint Open
Vol. 5, Issue 10 | Pages 904 - 910
18 Oct 2024
Bergman EM Mulligan EP Patel RM Wells J

Aims

The Single Assessment Numerical Evalution (SANE) score is a pragmatic alternative to longer patient-reported outcome measures (PROMs). The purpose of this study was to investigate the concurrent validity of the SANE and hip-specific PROMs in a generalized population of patients with hip pain at a single timepoint upon initial visit with an orthopaedic surgeon who is a hip preservation specialist. We hypothesized that SANE would have a strong correlation with the 12-question International Hip Outcome Tool (iHOT)-12, the Hip Outcome Score (HOS), and the Hip disability and Osteoarthritis Outcome Score (HOOS), providing evidence for concurrent validity of the SANE and hip-specific outcome measures in patients with hip pain.

Methods

This study was a cross-sectional retrospective database analysis at a single timepoint. Data were collected from 2,782 patients at initial evaluation with a hip preservation specialist using the iHOT-12, HOS, HOOS, and SANE. Outcome scores were retrospectively analyzed using Pearson correlation coefficients.


Bone & Joint Open
Vol. 5, Issue 10 | Pages 898 - 903
17 Oct 2024
Mazaheri S Poorolajal J Mazaheri A

Aims

The sensitivity and specificity of electrodiagnostic parameters in diagnosing carpal tunnel syndrome (CTS) have been reported differently, and this study aims to address this gap.

Methods

This case-control study was conducted on 57 cases with CTS and 58 controls without complaints, such as pain or paresthesia on the median nerve. The main assessed electrodiagnostic parameters were terminal latency index (TLI), residual latency (RL), median ulnar F-wave latency difference (FdifMU), and median sensory latency-ulnar motor latency difference (MSUMLD).


Bone & Joint Open
Vol. 5, Issue 10 | Pages 894 - 897
16 Oct 2024
Stoneham A Poon P Hirner M Frampton C Gao R

Aims

Body exhaust suits or surgical helmet systems (colloquially, ‘space suits’) are frequently used in many forms of arthroplasty, with the aim of providing personal protection to surgeons and, perhaps, reducing periprosthetic joint infections, although this has not consistently been borne out in systematic reviews and registry studies. To date, no large-scale study has investigated whether this is applicable to shoulder arthroplasty. We used the New Zealand Joint Registry to assess whether the use of surgical helmet systems was associated with lower all-cause revision or revision for deep infection in primary shoulder arthroplasties.

Methods

We analyzed 16,000 shoulder arthroplasties (hemiarthroplasties, anatomical, and reverse geometry prostheses) recorded on the New Zealand Joint Registry from its inception in 2000 to the present day. We assessed patient factors including age, BMI, sex, and American Society of Anesthesiologists (ASA) grade, as well as whether or not the operation took place in a laminar flow operating theatre.


Bone & Joint Open
Vol. 5, Issue 10 | Pages 851 - 857
10 Oct 2024
Mouchantaf M Parisi M Secci G Biegun M Chelli M Schippers P Boileau P

Aims. Optimal glenoid positioning in reverse shoulder arthroplasty (RSA) is crucial to provide impingement-free range of motion (ROM). Lateralization and inclination correction are not yet systematically used. Using planning software, we simulated the most used glenoid implant positions. The primary goal was to determine the configuration that delivers the best theoretical impingement-free ROM. Methods. With the use of a 3D planning software (Blueprint) for RSA, 41 shoulders in 41 consecutive patients (17 males and 24 females; means age 73 years (SD 7)) undergoing RSA were planned. For the same anteroposterior positioning and retroversion of the glenoid implant, four different glenoid baseplate configurations were used on each shoulder to compare ROM: 1) no correction of the RSA angle and no lateralization (C-L-); 2) correction of the RSA angle with medialization by inferior reaming (C+M+); 3) correction of the RSA angle without lateralization by superior compensation (C+L-); and 4) correction of the RSA angle and additional lateralization (C+L+). The same humeral inlay implant and positioning were used on the humeral side for the four different glenoid configurations with a 3 mm symmetric 135° inclined polyethylene liner. Results. The configuration with lateralization and correction of the RSA angle (C+L+) led to better ROM in flexion, extension, adduction, and external rotation (p ≤ 0.001). Only internal rotation was not significantly different between groups (p = 0.388). The configuration where correction of the inclination was done by medialization (C+M+) led to the worst ROM in adduction, extension, abduction, flexion, and external rotation of the shoulder. Conclusion. Our software study shows that, when using a 135° inlay reversed humeral implant, correcting glenoid inclination (RSA angle 0°) and lateralizing the glenoid component by using an angled bony or metallic augment of 8 to 10 mm provides optimal impingement-free ROM. Cite this article: Bone Jt Open 2024;5(10):851–857


Bone & Joint Open
Vol. 5, Issue 10 | Pages 818 - 824
2 Oct 2024
Moroder P Herbst E Pawelke J Lappen S Schulz E

Aims. The liner design is a key determinant of the constraint of a reverse total shoulder arthroplasty (rTSA). The aim of this study was to compare the degree of constraint of rTSA liners between different implant systems. Methods. An implant company’s independent 3D shoulder arthroplasty planning software (mediCAD 3D shoulder v. 7.0, module v. 2.1.84.173.43) was used to determine the jump height of standard and constrained liners of different sizes (radius of curvature) of all available companies. The obtained parameters were used to calculate the stability ratio (degree of constraint) and angle of coverage (degree of glenosphere coverage by liner) of the different systems. Measurements were independently performed by two raters, and intraclass correlation coefficients were calculated to perform a reliability analysis. Additionally, measurements were compared with parameters provided by the companies themselves, when available, to ensure validity of the software-derived measurements. Results. There were variations in jump height between rTSA systems at a given size, resulting in large differences in stability ratio between systems. Standard liners exhibited a stability ratio range from 126% to 214% (mean 158% (SD 23%)) and constrained liners a range from 151% to 479% (mean 245% (SD 76%)). The angle of coverage showed a range from 103° to 130° (mean 115° (SD 7°)) for standard and a range from 113° to 156° (mean 133° (SD 11°)) for constrained liners. Four arthroplasty systems kept the stability ratio of standard liners constant (within 5%) across different sizes, while one system showed slight inconsistencies (within 10%), and ten arthroplasty systems showed large inconsistencies (range 11% to 28%). The stability ratio of constrained liners was consistent across different sizes in two arthroplasty systems and inconsistent in seven systems (range 18% to 106%). Conclusion. Large differences in jump height and resulting degree of constraint of rTSA liners were observed between different implant systems, and in many cases even within the same implant systems. While the immediate clinical effect remains unclear, in theory the degree of constraint of the liner plays an important role for the dislocation and notching risk of a rTSA system. Cite this article: Bone Jt Open 2024;5(10):818–824


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. Results. Mean pain on the VAS was 51.3 (SD 20.1) in the patients eligible for surgery and 41.7 (SD 21.2) in the control group. The following domains of the SF-36 were associated with being eligible for surgery in univariate analyses: bodily pain, general health, vitality, social functioning, and emotional wellbeing. In multivariate analysis, only bodily pain was associated with pursuing surgical treatment. The RCD population’s values for physical role, bodily pain, and physical functioning were poorer compared to the values of the general population. Conclusion. Lower HRQoL, as indicated by the lower bodily pain score on the SF-36, was associated with the decision to undergo surgical treatment in patients with RCD. Therefore, HRQoL should be considered when determining treatment options for RCD. Cite this article: Bone Jt Open 2024;5(9):793–799


Bone & Joint Open
Vol. 5, Issue 9 | Pages 736 - 741
4 Sep 2024
Farr S Mataric T Kroyer B Barik S

Aims

The paediatric trigger thumb is a distinct clinical entity with unique anatomical abnormalities. The aim of this study was to present the long-term outcomes of A1 pulley release in idiopathic paediatric trigger thumbs based on established patient-reported outcome measures.

Methods

This study was a cross-sectional, questionnaire-based study conducted at a tertiary care orthopaedic centre. All cases of idiopathic paediatric trigger thumbs which underwent A1 pulley release between 2004 and 2011 and had a minimum follow-up period of ten years were included in the study. The abbreviated version of the Disabilities of Arm, Shoulder and Hand questionnaire (QuickDASH) was administered as an online survey, and ipsi- and contralateral thumb motion was assessed.


Bone & Joint Open
Vol. 5, Issue 9 | Pages 729 - 735
3 Sep 2024
Charalambous CP Hirst JT Kwaees T Lane S Taylor C Solanki N Maley A Taylor R Howell L Nyangoma S Martin FL Khan M Choudhry MN Shetty V Malik RA

Aims. Steroid injections are used for subacromial pain syndrome and can be administered via the anterolateral or posterior approach to the subacromial space. It is not currently known which approach is superior in terms of improving clinical symptoms and function. This is the protocol for a randomized controlled trial (RCT) to compare the clinical effectiveness of a steroid injection given via the anterolateral or the posterior approach to the subacromial space. Methods. The Subacromial Approach Injection Trial (SAInT) study is a single-centre, parallel, two-arm RCT. Participants will be allocated on a 1:1 basis to a subacromial steroid injection via either the anterolateral or the posterior approach to the subacromial space. Participants in both trial arms will then receive physiotherapy as standard of care for subacromial pain syndrome. The primary analysis will compare the change in Oxford Shoulder Score (OSS) at three months after injection. Secondary outcomes include the change in OSS at six and 12 months, as well as the Pain Numeric Rating Scale (0 = no pain, 10 = worst pain), Disabilities of Arm, Shoulder and Hand questionnaire (DASH), and 36-Item Short-Form Health Survey (SF-36) (RAND) at three months, six months, and one year after injection. Assessment of pain experienced during the injection will also be determined. A minimum of 86 patients will be recruited to obtain an 80% power to detect a minimally important difference of six points on the OSS change between the groups at three months after injection. Conclusion. The results of this trial will demonstrate if there is a difference in shoulder pain and function after a subacromial space steroid injection between the anterolateral versus posterior approach in patients with subacromial pain syndrome. This will help to guide treatment for patients with subacromial pain syndrome. Cite this article: Bone Jt Open 2024;5(9):729–735


Bone & Joint Open
Vol. 5, Issue 8 | Pages 637 - 643
6 Aug 2024
Abelleyra Lastoria DA Casey L Beni R Papanastasiou AV Kamyab AA Devetzis K Scott CEH Hing CB

Aims. Our primary aim was to establish the proportion of female orthopaedic consultants who perform arthroplasty via cases submitted to the National Joint Registry (NJR), which covers England, Wales, Northern Ireland, the Isle of Man, and Guernsey. Secondary aims included comparing time since specialist registration, private practice participation, and number of hospitals worked in between male and female surgeons. Methods. Publicly available data from the NJR was extracted on the types of arthroplasty performed by each surgeon, and the number of procedures of each type undertaken. Each surgeon was cross-referenced with the General Medical Council (GMC) website, using GMC number to extract surgeon demographic data. These included sex, region of practice, and dates of full and specialist registration. Results. Of 2,895 surgeons contributing to the NJR in 2023, 102 (4%) were female. The highest proportions of female surgeons were among those who performed elbow (n = 25; 5%), shoulder (n = 24; 4%), and ankle (n = 8; 4%) arthroplasty. Hip (n = 66; 3%) and knee arthroplasty (n = 39; 2%) had the lowest female representation. Female surgeons had been practising for a median of 10.4 years since specialist registration compared to 13.7 years for males (p < 0.001). Northern Ireland was the region with the highest proportion of female arthroplasty surgeons (8%). A greater proportion of male surgeons worked in private practice (63% vs 24%; p < 0.001) and in multiple hospitals (74% vs 40%; p < 0.001). Conclusion. Only 4% of surgeons currently contributing cases to the NJR are female, with the highest proportion performing elbow arthroplasty (5%). Female orthopaedic surgeons in the NJR are earlier in their careers than male surgeons, and are less involved in private practice. There is a wide geographical variation in the proportion of female arthroplasty surgeons. Cite this article: Bone Jt Open 2024;5(8):637–643


Bone & Joint Open
Vol. 5, Issue 7 | Pages 570 - 580
10 Jul 2024
Poursalehian M Ghaderpanah R Bagheri N Mortazavi SMJ

Aims

To systematically review the predominant complication rates and changes to patient-reported outcome measures (PROMs) following osteochondral allograft (OCA) transplantation for shoulder instability.

Methods

This systematic review, following PRISMA guidelines and registered in PROSPERO, involved a comprehensive literature search using PubMed, Embase, Web of Science, and Scopus. Key search terms included “allograft”, “shoulder”, “humerus”, and “glenoid”. The review encompassed 37 studies with 456 patients, focusing on primary outcomes like failure rates and secondary outcomes such as PROMs and functional test results.


Bone & Joint Open
Vol. 5, Issue 7 | Pages 543 - 549
3 Jul 2024
Davies AR Sabharwal S Reilly P Sankey RA Griffiths D Archer S

Aims

Shoulder arthroplasty is effective in the management of end-stage glenohumeral joint arthritis. However, it is major surgery and patients must balance multiple factors when considering the procedure. An understanding of patients’ decision-making processes may facilitate greater support of those considering shoulder arthroplasty and inform the outcomes of future research.

Methods

Participants were recruited from waiting lists of three consultant upper limb surgeons across two NHS hospitals. Semi-structured interviews were conducted with 12 participants who were awaiting elective shoulder arthroplasty. Transcribed interviews were analyzed using a grounded theory approach. Systematic coding was performed; initial codes were categorized and further developed into summary narratives through a process of discussion and refinement. Data collection and analyses continued until thematic saturation was reached.


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 Open
Vol. 5, Issue 5 | Pages 419 - 425
20 May 2024
Gardner EC Cheng R Moran J Summer LC Emsbo CB Gallagher RG Gong J Fishman FG

Aims

The purpose of this survey study was to examine the demographic and lifestyle factors of women currently in orthopaedic surgery.

Methods

An electronic survey was conducted of practising female orthopaedic surgeons based in the USA through both the Ruth Jackson Society and the online Facebook group “Women of Orthopaedics”.


Bone & Joint Open
Vol. 5, Issue 5 | Pages 411 - 418
20 May 2024
Schneider P Bajammal S Leighton R Witges K Rondeau K Duffy P

Aims

Isolated fractures of the ulnar diaphysis are uncommon, occurring at a rate of 0.02 to 0.04 per 1,000 cases. Despite their infrequency, these fractures commonly give rise to complications, such as nonunion, limited forearm pronation and supination, restricted elbow range of motion, radioulnar synostosis, and prolonged pain. Treatment options for this injury remain a topic of debate, with limited research available and no consensus on the optimal approach. Therefore, this trial aims to compare clinical, radiological, and functional outcomes of two treatment methods: open reduction and internal fixation (ORIF) versus nonoperative treatment in patients with isolated ulnar diaphyseal fractures.

Methods

This will be a multicentre, open-label, parallel randomized clinical trial (under National Clinical Trial number NCT01123447), accompanied by a parallel prospective cohort group for patients who meet the inclusion criteria, but decline randomization. Eligible patients will be randomized to one of the two treatment groups: 1) nonoperative treatment with closed reduction and below-elbow casting; or 2) surgical treatment with ORIF utilizing a limited contact dynamic compression plate and screw construct. The primary outcome measured will be the Disabilities of the Arm, Shoulder and Hand questionnaire score at 12 months post-injury. Additionally, functional outcomes will be assessed using the 36-Item Short Form Health Survey and pain visual analogue scale, allowing for a comparison of outcomes between groups. Secondary outcome measures will encompass clinical outcomes such as range of motion and grip strength, radiological parameters including time to union, as well as economic outcomes assessed from enrolment to 12 months post-injury.


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. 5, Issue 3 | Pages 162 - 173
4 Mar 2024
Di Mascio L Hamborg T Mihaylova B Kassam J Shah B Stuart B Griffin XL

Aims. Is it feasible to conduct a definitive multicentre trial in community settings of corticosteroid injections (CSI) and hydrodilation (HD) compared to CSI for patients with frozen shoulder? An adequately powered definitive randomized controlled trial (RCT) delivered in primary care will inform clinicians and the public whether hydrodilation is a clinically and cost-effective intervention. In this study, prior to a full RCT, we propose a feasibility trial to evaluate recruitment and retention by patient and clinician willingness of randomization; rates of withdrawal, crossover and attrition; and feasibility of outcome data collection from routine primary and secondary care data. Methods. In the UK, the National Institute for Health and Care Excellence (NICE) advises that prompt early management of frozen shoulder is initiated in primary care settings with analgesia, physiotherapy, and joint injections; most people can be managed without an operation. Currently, there is variation in the type of joint injection: 1) CSI, thought to reduce the inflammation of the capsule reducing pain; and 2) HD, where a small volume of fluid is injected into the shoulder joint along with the steroid, aiming to stretch the capsule of the shoulder to improve pain, but also allowing greater movement. The creation of musculoskeletal hubs nationwide provides infrastructure for the early and effective management of frozen shoulder. This potentially reduces costs to individuals and the wider NHS perhaps negating the need for a secondary care referral. Results. We will conduct a multicentre RCT comparing CSI and HD in combination with CSI alone. Patients aged 18 years and over with a clinical diagnosis of frozen shoulder will be randomized and blinded to receive either CSI and HD in combination, or CSI alone. Feasibility outcomes include the rate of randomization as a proportion of eligible patients and the ability to use routinely collected data for outcome evaluation. This study has involved patients and the public in the trial design, dissemination methods, and how to include groups who are underserved by research. Conclusion. We will disseminate findings among musculoskeletal clinicians via the British Orthopaedic Association, the Chartered Society of Physiotherapy, the Royal College of Radiologists, and the Royal College of General Practitioners. To ensure wide reach we will communicate findings through our established network of charities and organizations, in addition to preparing dissemination findings in Bangla and Urdu (commonly spoken languages in northeast London). If a full trial is shown to be feasible, we will seek additional National Institute for Health and Care Research funding for a definitive RCT. This definitive study will inform NICE guidelines for the management of frozen shoulder. Cite this article: Bone Jt Open 2024;5(3):162–173