NCT01116362CompletedPhase 2
Study of Surgical Methods for Repair of Clean Transections in Peripheral Nerve Injuries
Isfahan University of Medical Sciences1 site in 1 country46 target enrollmentStarted: March 2008Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- motor function
Study Overview
Brief Summary
The purpose of this study is to determine which surgical approach is better for clean transection injury in peripheral nerves in outcomes.
Detailed Description
Treatment of injuries to major nerve trunks in the hand and upper extremity remains a major and challenging reconstructive problem. Our goal was to compare primary versus secondary repair of median and\or ulnar nerve by electrodiagnostic assessment and clinical examination.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •patients with confirmed clean transection injury between shoulder and wrist
Exclusion Criteria
- •crush injuries
Outcomes
Primary Outcomes
motor function
Time Frame: at 18 months post-operatively
identification of motor level were done based on British Medical Research Council guided.The abductor pollicis brevis (APB) was used for the median nerve and the abductor digiti minimi (ADM) for the ulnar nerve. as follows: 0, M0, M1 and M2; 1, M3; 2, M4.
Secondary Outcomes
- sensory recovery(at 18 months post-operatively)
- nerve conduction velocity(at 18 months post-operatively)
- electromyography(at 18 months post-operatively)
Investigators
Study Sites (1)
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