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Study Comparing Surgical Treatment Versus Non-surgical Treatment of Ulnar Fractures

2014-07-23 21:09:05 | BioPortfolio

Summary

The purpose of this study is to determine if surgery using a plate and screws to fix a forearm fracture (ulnar shaft) will improve functional outcome compared to non-operative treatment out to 1 year of follow-up. It is hypothesized that in skeletally mature patients with isolated ulnar shaft fractures, the patients treated with surgery will have improved functional outcomes compared to non-surgical treatment with below-elbow cast at 1-year follow-up. This will be measured by the Disabilities of the Arm, Shoulder and Hand (DASH) scores. Secondary outcomes will include SF-36, range of motion, pain, grip strength, return to work, and time to union.

Description

Ulnar diaphyseal, or "nightstick", fractures are uncommon, but fraught with complications (Pollock et al., 1983; Grace & Witmer, 1980, Atkin et al., 1995) and may prevent return to work (Atkin et al., 1995). 3 systematic reviews have concluded that there is insufficient evidence to guide treatment of isolated ulnar shaft fractures (Handoll & Pearce, 2000; Mackay et al., 2000; Bhandari & Schemitsch, 2004) and there has been no comparison between operative and non-operative management. Therefore, there is true clinical equipoise regarding optimal treatment of these injuries.

The aim of this study is to determine if open reduction and internal fixation (ORIF) is more efficacious than closed reduction and below-elbow casting for 6 weeks in restoring function of the forearm and wrist.

We hypothesize that in skeletally mature patients with isolated ulnar shaft fractures, ORIF will improve functional outcomes compared to non-operative treatment with below-elbow cast at 1-year follow-up.

The primary objective is to compare Disabilities of the Arm, Shoulder and Hand (DASH) scores at 1-year post-injury. Secondary outcome measures include SF-36, range of motion, pain, grip strength, return to work and time to union.

The study design is a multi-centre, open-label parallel randomized clinical trial. 100 skeletally mature patients with closed, extra-articular isolated ulnar diaphyseal fractures will be randomized to one of the two treatment arms. Polytrauma patients or those with pre-existing bone pathology will be excluded. Post-treatment follow-up evaluation will occur at 2, 6 and 12 weeks and at 6 and 12 months. Interim analysis will be completed by an independent Data Safety and Monitoring Committee to ensure patient safety.

Radiologic displacement, angulation and time to union will be evaluated by two independent, blinded observers. Time to fracture union will be defined as bridging callus across the fracture line on 2 views.

The sample size was calculated as 50 patients per group. Independent samples t-test will be used to compare the DASH and SF-36 scores and return to work. An ANOVA will be used for the DASH, SF-36 and range of motion comparison at each follow-up.

There is true clinical equipoise regarding optimal treatment for isolated ulnar diaphyseal fractures, therefore, the results of this trial will provide robust evidence for clinical decision-making in the treatment of these injuries by orthopaedic surgeons.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Fracture

Intervention

Open reduction and internal fixation, Closed reduction and short-arm cast

Location

Dr. Paul J Duffy
Calgary
Alberta
Canada
T2N 2T9

Status

Recruiting

Source

University of Calgary

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:09:05-0400

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