Pulsed electromagnetic fields in the treatment of fresh scaphoid fractures. Clinical and radiological outcome. A multi centre, prospective, double-blind, placebo controlled, randomized trial.

Recruiting

• Conditions: healing disorder; scaphoid non-union; 10017322

• Registration Number: NL-OMON33275
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 110

Inclusion Criteria

All unilateral fresh scaphoid fractures, types A1, A2, B2 and B3 (all stable and unstable acute fractures except the dislocated and comminuted ones) according to the Herbert classification of scaphoid fractures.

Exclusion Criteria

Exclusion criteria are pregnancy, presence of a life-supporting implanted electronical device, additional fractures of wrist, carpal or metacarpal bones and pre-existing impairment in wrist function.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint is number of scaphoid fracture unions (healed fractures) at<br /><br>six weeks.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are time interval to clinical and radiological<br /><br>consolidation, number of non-unions, functional status at 52 weeks and<br /><br>non-adherence to the treatment protocol.</p><br>