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

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

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

Study Overview

• Status: Completed
• Conditions: Peripheral Nerve Injury
• Intervention / Treatment: Procedure: secondary repair; Procedure: primary repair

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
• Enrollment (Actual): 46
• Phase: Phase 2

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Isfahan, Iran, Islamic Republic of
    • Al-Zahra University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients with confirmed clean transection injury between shoulder and wrist

Exclusion Criteria:

• crush injuries

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Isfahan University of Medical Sciences

Publications and helpful links

Helpful Links

• Isfahan university of medical science

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (ACTUAL): December 1, 2009
• Study Completion (ACTUAL): December 1, 2009

Study Registration Dates

• First Submitted: May 3, 2010
• First Submitted That Met QC Criteria: May 3, 2010
• First Posted (ESTIMATE): May 5, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): May 20, 2010
• Last Update Submitted That Met QC Criteria: May 19, 2010
• Last Verified: March 1, 2008

More Information

Terms related to this study

• Keywords: primary; repair; ulna; median
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Peripheral Nervous System Diseases; Trauma, Nervous System; Peripheral Nerve Injuries
• Other Study ID Numbers: ASD-1213-2