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

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ClinicalTrials.gov Identifier: NCT01116362
Recruitment Status : Completed
First Posted : May 5, 2010
Last Update Posted : May 20, 2010
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Peripheral Nerve Injury 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 Type : Interventional  (Clinical Trial)
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 : March 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

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Arm Intervention/treatment
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 Name: NCV,EMG

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 Name: NCV,EMG




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients with confirmed clean transection injury between shoulder and wrist

Exclusion Criteria:

  • crush injuries

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01116362


Locations
Iran, Islamic Republic of
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

Additional Information:
Responsible Party: Dr. Alireza Yousefy/Associate Professor of Medical Education, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01116362     History of Changes
Other Study ID Numbers: ASD-1213-2
First Posted: May 5, 2010    Key Record Dates
Last Update Posted: May 20, 2010
Last Verified: March 2008

Keywords provided by Isfahan University of Medical Sciences:
ulna
median
repair
primary

Additional relevant MeSH terms:
Peripheral Nerve Injuries
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries