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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Study of Surgical Methods for Repair of Clean Transections in Peripheral Nerve Injuries

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 Summary: 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.
Sponsor: Isfahan University of Medical Sciences

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • sensory recovery [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: Isfahan University of Medical Sciences

Dates:
Date Received: May 3, 2010
Date Started: March 2008
Date Completion:
Last Updated: May 19, 2010
Last Verified: March 2008