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

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

Detailed Description
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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.

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

Conditions
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Peripheral Nerve Injury

Intervention / Treatment
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* Procedure: primary repair
* Procedure: secondary repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with confirmed clean transection injury between shoulder and wrist Exclusion Criteria: crush injuries
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: secondary repair<br>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. | Procedure: secondary repair<br>* 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.<br>* Other names: NCV,EMG;|
| Other: primary repair<br>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. | Procedure: primary repair<br>* 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.<br>* Other names: NCV,EMG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| motor function | 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. | at 18 months post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensory recovery | 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. | at 18 months post-operatively | 
| nerve conduction velocity | 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. | at 18 months post-operatively | 
| electromyography | 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. | at 18 months post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ulna, median, repair, primary