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Completed

NCT Number: NCT01116362

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

The purpose of this study is to determine which surgical approach is better for clean transection injury in peripheral nerves in outcomes.

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Key information

Conditions

Peripheral Nerve Injury Nervous System Diseases Neuromuscular Diseases Peripheral Nerve Injuries Peripheral Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Al-zahra university hospital

Isfahan, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with confirmed clean transection injury between shoulder and wrist

Exclusion criteria

  • crush injuries

Treatment and study plan

primary repair

Procedure

during the 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.

Other names: NCV,EMG

secondary repair

Procedure

after one 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.

Other names: NCV,EMG

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Isfahan University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 5, 2010
Registry last updated
May 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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