Pulsed Electromagnetic Fields in the treatment of fresh scaphoid fractures. Clinical and radiological outcome. A multicentre, prospective, double-blind, placebo-controlled, randomized trial. (CMO nr 2009/196) (ABR nr NL27191.091.09).
Recruiting
- Conditions
- scaphoid fracture, bone growth stimulation, electromagnetic fields, fracture healing, ununited fracture, double-blind method
- Registration Number
- NL-OMON27135
- Lead Sponsor
- ZonMW, academisch ziekenhuis Maastricht
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 110
Inclusion Criteria
All unilateral scaphoid fractures, types A1, A2, B1, B2 and B3.
Exclusion Criteria
1. Pregnancy;
2. Presence of a life-supporting implanted electronical device;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Radiological proof of union of the scaphoid fracture at six weeks after initiation of the electromagnetic stimulation, determined by means of CT-scanning.
- Secondary Outcome Measures
Name Time Method 1. Radiological and clinical consolidation at 24 weeks (non-union ?);<br /><br>2. Functional outcome and quality of life at 52 weeks.