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

This study has been completed.
Sponsor:
Information provided by:
Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01116362
First received: May 3, 2010
Last updated: May 19, 2010
Last verified: March 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Peripheral Nerve Injury
 Procedure: primary repair
Procedure: secondary repair
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Surgical Methods for Repair of Clean Transections in Peripheral Nerve Injuries

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Isfahan University of Medical Sciences:

Primary Outcome Measures:
  • motor function [ Time Frame: at 18 months post-operatively ] [ Designated as safety issue: Yes ]
    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:
  • sensory recovery [ Time Frame: at 18 months post-operatively ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 46
Study Start Date: March 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients with confirmed clean transection injury between shoulder and wrist

Exclusion Criteria:

  • crush injuries
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Isfahan university of medical science  This link exits the ClinicalTrials.gov site

No publications provided

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
Study First Received: May 3, 2010
Last Updated: May 19, 2010
Health Authority: Iran: Ministry of Health

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

ClinicalTrials.gov processed this record on May 19, 2013