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

Peripheral Nerve Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01116362
• Other study ID #: ASD-1213-2
• Status: Completed
• Phase: Phase 2
• First received: May 3, 2010
• Last updated: May 19, 2010
• Start date: March 2008
• Est. completion date: December 2009

Study information

• Verified date: March 2008
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients with confirmed clean transection injury between shoulder and wrist

Exclusion Criteria:

• crush injuries

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Nerve Injuries
• Peripheral Nerve Injury

Intervention

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.
• 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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Al-zahra university hospital	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes

External Links

•   Isfahan university of medical science