Comparing Primary With Secondary Repair of Based on Electrodiagnostic Assessment and Clinical Examination

Phase 2

Completed

• Conditions: Peripheral Nerve Injury
• Interventions: Procedure: secondary repair; Procedure: primary repair

• Registration Number: NCT01116362
• Lead Sponsor: Isfahan University of Medical Sciences

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 Timeline

• Status Verified: 2008-03
• Study Start: 2008-03
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Study First Submitted: 2010-05-03
• Study First Submitted QC: 2010-05-03
• Study First Posted: 2010-05-05
• Last Update Submitted: 2010-05-19
• Last Update Posted: 2010-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• patients with confirmed clean transection injury between shoulder and wrist

Exclusion Criteria

• crush injuries

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
secondary repair	secondary repair	secondary closure beyond the first week.the nerve was conducted to repair as end to end (epi-epineurium, epi-epineurium) anastomosis. This was performed following the repair of present tendons and muscle injuries.
primary repair	primary repair	during first days,the nerve was conducted to repair as end to end (epi-epineurium, epi-epineurium) anastomosis. This was performed following the repair of present tendons and muscle injuries.

Primary Outcome Measures

Name	Time	Method
motor function	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 Outcome Measures

Name	Time	Method
sensory recovery	at 18 months post-operatively	identification of motor and sensory 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. The results scored as follows: 0, S0, S1 and S2; 1, S3; 2, S4 and S5.
nerve conduction velocity	at 18 months post-operatively	For electrodiagnostic assessment, nerve conduction velocity (NCV) was tested as motor and sensory. The results categorized according to the Yale sensory scale and the severity of sensation and function of the nerves was scored as follows: 0, no sensation; 1, decreased or abnormal sensation; 2, normal sensation.
electromyography	at 18 months post-operatively	For an EMG, a needle electrode was inserted through the skin into the muscle which injured nerve supplied. The presence, size and shape of the waveform registered and the ability of the muscle to respond when the nerves were stimulated. Also these results scored as follows: 0, no activity; 1, few or single movement; 2, partial activity; 3, full activity.

Trial Locations

Locations (1)

Al-zahra university hospital; 🇮🇷 Isfahan, Iran, Islamic Republic of