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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. Ethics and dissemination. This trial has been approved by the lead site Conjoint Health Research Ethics Board (CHREB; REB14-2004) and local ethics boards at each participating site. Findings from the trial will be disseminated through presentations at regional, national, and international scientific conferences and public forums. The primary results and secondary findings will be submitted for peer-reviewed publication. Cite this article: Bone Jt Open 2024;5(5):411–418


Bone & Joint Open
Vol. 6, Issue 3 | Pages 291 - 297
7 Mar 2025
Zambito K Kushchayeva Y Bush A Pisani P Kushchayeva S Peters M Birch N

Aims

Assessment of bone health is a multifaceted clinical process, incorporating biochemical and diagnostic tests that should be accurate and reproducible. Dual-energy X-ray absorptiometry (DXA) is the reference standard for evaluation of bone mineral density, but has known limitations. Alternatives include quantitative CT (q-CT), MRI, and peripheral quantitative ultrasound (QUS). Radiofrequency echographic multispectrometry (REMS) is a new generation of ultrasound technology used for the assessment of bone mineral density (BMD) at axial sites that is as accurate as quality-assured DXA scans. It also provides an assessment of the quality of bone architecture. This will be of direct value and significance to orthopaedic surgeons when planning surgical procedures, including fracture fixation and surgery of the hip and spine, since BMD alone is a poor predictor of fracture risk.

Methods

The various other fixed-site technologies such as high-resolution peripheral q-CT (HR-pQCT) and MRI offer no further significant prognostic advantages in terms of assessing bone structure and BMD to predict fracture risk. QUS was the only widely adopted non-fixed imaging option for bone health assessment, but it is not considered adequately accurate to provide a quantitative assessment of BMD or provide a prediction of fracture risk. In contrast, REMS has a robust evidence base that demonstrates its equivalence to DXA in determining BMD at axial sites. Fracture prediction using REMS, combining the output of fragility information and BMD, has been established as more accurate than when using BMD alone.


Aims

Olecranon fractures are usually caused by falling directly on to the olecranon or following a fall on to an outstretched arm. Displaced fractures of the olecranon with a stable ulnohumeral joint are commonly managed by open reduction and internal fixation. The current predominant method of management of simple displaced fractures with ulnohumeral stability (Mayo grade IIA) in the UK and internationally is a low-cost technique using tension band wiring. Suture or suture anchor techniques have been described with the aim of reducing the hardware related complications and reoperation. An all-suture technique has been developed to fix the fracture using strong synthetic sutures alone. The aim of this trial is to investigate the clinical and cost-effectiveness of tension suture repair versus traditional tension band wiring for the surgical fixation of Mayo grade IIA fractures of the olecranon.

Methods

SOFFT is a multicentre, pragmatic, two-arm parallel-group, non-inferiority, randomized controlled trial. Participants will be assigned 1:1 to receive either tension suture fixation or tension band wiring. 280 adult participants will be recruited. The primary outcome will be the Disabilities of the Arm, Shoulder and Hand (DASH) score at four months post-randomization. Secondary outcome measures include DASH (at 12, 18, and 24 months), pain, Net Promotor Score (patient satisfaction), EuroQol five-dimension five-level score (EQ-5D-5L), radiological union, complications, elbow range of motion, and re-operations related to the injury or to remove metalwork. An economic evaluation will assess the cost-effectiveness of treatments.