A clinical trial to assess whether the new nerve repair technique (PEG fusion) is safe and effective in adults with traumatic complete cuts involving large nerves in the forearm.
- Conditions
- Peripheral nerve injuries
- Registration Number
- SLCTR/2021/029
- Lead Sponsor
- Dr. Gayan Ekanayake
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
a.Age 18 years to 60 years
b. Both males and females
c.Admitted to accident and orthopedic services department of National Hospital of Sri Lanka
d.Sustaining single complete cut injury to median and/or ulnar nerve at forearm (defined as the nerve is cut at or in between distal wrist crease and elbow flexion crease due to a sharp cutting mechanism. e.g., glass, sword, sharp knife)
e.Nerve repair performed within 72 hours from the time of injury
a.Patients who are unable to provide valid informed consent
b.Patients sustaining injury to both radial and ulnar arteries in addition to nerve injury
c.Patients sustaining simultaneous bilateral upper limb nerve/ tendon injury
d.Patients with any past history of significant injury or disability of contralateral upper limb
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method • Parameter- Disability after nerve repair with PEG fusion<br>• Tool- DASH questionnaire <br>Reference- DASH | Welcome to our website where you will find up-to-date information about the DASH Outcome Measure, the QuickDASH and related DASH [Internet]. [cited 2021 Jun 7]. Available from: https://dash.iwh.on.ca<br><br> [Post-operative week 12, 24 36, and 48.]<br>• Parameter- Functional and aesthetic outcome following nerve repair with PEG fusion<br>• Tool- Michigan Hand Questionnaire<br>Reference- KC, Pillsbury MS, Walters MR, Hayward RA. Reliability and validity testing of the Michigan Hand Outcomes Questionnaire. J Hand Surg. 1998 Jul 1;23(4):575–87.<br> [Post-operative week 12, 24, 36 and 48.]<br>• Parameter- Adverse outcomes following nerve repair with PEG fusion using clinical assessment<br> [ Any timepoint up to 48 weeks post-operatively]<br> []<br> []<br>
- Secondary Outcome Measures
Name Time Method