Nerve Transfers for Spinal Cord Injuries
Nerve Transfer surgery can provide improved hand function following cervical spinal cord injuries
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Restoring Hand Function Using Nerve Transfers in Persons With Spinal Cord Injury|
- Change in upper motor strength [ Time Frame: 24 months ] [ Designated as safety issue: No ]Patients motor strength will be assessed over 24 months of clinical follow-up with conventional manual motor testing
- Change in Disabilities of Arm, Shoulder, and Hand (DASH) scores [ Time Frame: 24 months ] [ Designated as safety issue: No ]Pre-operative, 3, 6, 12, and 24 month
- Change in Short Form 36 (SF-36) scores [ Time Frame: 24 months ] [ Designated as safety issue: No ]The change in SF-36 scores will be followed over time and assessed pre-operatively, 3,6,12, and 24 months post-operatively.
- Rates of Intraoperative and Post-operative complications [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Effect of timing on surgical intervention [ Time Frame: 24 months ] [ Designated as safety issue: No ]Assess the effect of timing on primary and secondary outcome measures, early (<12 months) vs. (>12 months)
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||October 2016|
|Estimated Primary Completion Date:||October 2016 (Final data collection date for primary outcome measure)|
Experimental: Nerve Transfer
Surgical - Nerve transfers for patients with stable cervical spinal cord injuries
Procedure: Nerve Transfer
A single nerve transfer will be offered to the surgical group, the brachialis branch to the anterior interosseous nerve.
Current treatment strategies of acute cervical spinal cord injuries remain limited. Treatment options that provide meaningful improvements in patient quality of life and long-term functional independence will provide a significant public health impact.
Specific Aim: Measure the efficacy of nerve transfer surgery in the treatment of patients with complete cervical spinal cord injuries with no hand function. Optimize the efficiency of nerve transfer surgery by evaluating patient outcomes in relation to patient selection and optimal timing the the surgery. Hypothesis: Peripheral nerve transfers in patients with spinal cord injuries will improve hand function and provide improvement in patient quality of life and functional independence.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01714349
|Contact: Wilson Ray, MDfirstname.lastname@example.org|
|Contact: William Janes, OTD, MSCIemail@example.com|
|United States, Missouri|
|St. Louis, Missouri, United States, 63110|
|Contact: William Janes, OTD, MSCI 314-289-4270 firstname.lastname@example.org|
|Principal Investigator: Wilson Ray, MD|
|Sub-Investigator: Jack Engsberg, PhD|
|Sub-Investigator: William Janes, OTD, MSCI|
|Principal Investigator:||Wilson Z Ray, MD||Washington University School of Medicine|