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

NCT01116362 | Completed Phase 2 DMC

• 1 other identifier: ASD-1213-2
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Peripheral Nerve Injury

Keywords

ulna; median; repair; primary

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• sensory recovery

  at 18 months post-operatively

• nerve conduction velocity

  at 18 months post-operatively

• electromyography

  at 18 months post-operatively

Study Arms (2)

secondary repair

OTHER

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

primary repair

OTHER

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

Interventions

primary repair 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.

Also known as: NCV,EMG

primary repair

secondary repair 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.

Also known as: NCV,EMG

secondary repair

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with confirmed clean transection injury between shoulder and wrist

You may not qualify if:

• crush injuries

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead

Study Sites (1)

Al-zahra university hospital

Isfahan, Iran

Location

MeSH Terms

Conditions

Peripheral Nerve Injuries

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• hamidreza shemshaki, MD

  MD,research comittee

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 3, 2010
• First Posted: May 5, 2010
• Study Start: March 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: May 20, 2010

Record last verified: 2008-03

Locations

IR (1)