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

Sponsor
Isfahan University of Medical Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT01116362
Collaborator
(none)
46
Enrollment
1
Location
2
Arms
21
Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: primary repair
  • Procedure: secondary repair
 Phase 2

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
Actual Enrollment :
46 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Study of Surgical Methods for Repair of Clean Transections in Peripheral Nerve Injuries
Study Start Date :
Mar 1, 2008
Actual Primary Completion Date :
Dec 1, 2009
Actual Study Completion Date :
Dec 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Other: 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.

Procedure: secondary repair
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

    		•
    Other: 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.

    Procedure: primary repair
    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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    3. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • patients with confirmed clean transection injury between shoulder and wrist
    Exclusion Criteria:
    • crush injuries

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Al-zahra university hospital Isfahan Iran, Islamic Republic of

    Sponsors and Collaborators

    • Isfahan University of Medical Sciences

    Investigators

    • Study Chair: hamidreza shemshaki, MD, MD,research comittee

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01116362
    Other Study ID Numbers:
    • ASD-1213-2
    First Posted:
    May 5, 2010
    Last Update Posted:
    May 20, 2010
    Last Verified:
    Mar 1, 2008
    Keywords provided by , ,
    ulna
    median
    repair
    primary
    Additional relevant MeSH terms:
    Peripheral Nerve Injuries

    Study Results

    No Results Posted as of May 20, 2010