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

NCT ID: NCT01116362

Last Updated: 2010-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-12-31

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.

Conditions

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Peripheral Nerve Injury

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type OTHER

secondary repair

Intervention Type 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.

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.

Group Type OTHER

primary repair

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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NCV,EMG NCV,EMG

Eligibility Criteria

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Inclusion Criteria

* patients with confirmed clean transection injury between shoulder and wrist

Exclusion Criteria

* crush injuries
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Isfahan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Isfahan University of Medical Sciences

Principal Investigators

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hamidreza shemshaki, MD

Role: STUDY_CHAIR

MD,research comittee

Locations

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Al-zahra university hospital

Isfahan, , Iran

Site Status

Countries

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Iran

Other Identifiers

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ASD-1213-2

Identifier Type: -

Identifier Source: org_study_id

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