Nerve Transfers to Restore Hand Function in Spinal Cord Injury
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02861612|
Recruitment Status : Withdrawn (Insufficient patient recruitment)
First Posted : August 10, 2016
Last Update Posted : March 21, 2019
|Condition or disease||Intervention/treatment|
|Quadriplegia Spinal Cord Diseases Spinal Cord Injuries||Procedure: Nerve Transfer Surgery|
Cervical spinal cord injury is a life-altering injury that results in profound loss of upper limb function. Hand function is essential to basic activities of daily living and consequently has a significant impact on patients' quality of life. Tendon transfers and/or tenodesis have traditionally been used to restore hand function in spinal cord injuries - however, in recent years there is growing interest in the role of nerve transfers as a means of accomplishing this goal. Although preliminary results indicate nerve transfers may be well-suited for patients with spinal cord injury, their long term efficacy has not been demonstrated.
This study seeks to evaluate the efficacy of nerve transfers in restoring hand function in patients with cervical spinal injuries. Eligible patients will receive nerve transfer procedure(s) (e.g. brachialis to anterior interosseous nerve, supinator to posterior interosseous) and will be followed post-operatively to assess for changes in strength, functional independence, and quality of life.
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Nerve Transfers to Restore Hand Function in Spinal Cord Injury|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||March 18, 2019|
|Actual Study Completion Date :||March 18, 2019|
This is an observational study that looks at function and quality of life in patients before and after nerve transfer surgery.
Procedure: Nerve Transfer Surgery
Unilateral surgery will be performed under general non-paralytic anesthesia and no-tourniquet conditions to allow for responsive nerve simulation.
- Upper extremity function - Myometric measures of strength (donor and recipient muscle groups) [ Time Frame: Change from baseline at 6, 12, 24, 30 and 36 months post-surgery ]Valid and reliable quantitative muscle strength measurement
- Upper extremity function - Manual muscle testing (MRC) [ Time Frame: Change from baseline at 6, 12, 24, 30 and 36 months post-surgery ]Quantitative assessment of motor function (MRC)
- Upper extremity function - Graded Redefined Assessment of Strength, Sensibility and Prehension test (GRASSP) [ Time Frame: Change from baseline at 6, 12, 24, 30 and 36 months post-surgery ]Valid, reliable and responsive measure of sensorimotor upper limb impairment specifically designed for patients with cervical SCI
- Upper extremity function - Range of motion [ Time Frame: Change from baseline at 6, 12, 24, 30 and 36 months post-surgery ]Quantitative assessment of range of motion (degrees)
- Health related quality of life - The Short Form (SF)-36 [ Time Frame: Change from baseline at 6, 12, 24, 30 and 36 months post-surgery ]Valid and responsive measure of quality of life in surgical patients
- Health related quality of life - Spinal Cord Independence Measure (SCIM I) [ Time Frame: Change from baseline at 6, 12, 24, 30 and 36 months post-surgery ]Disability scale developed to specifically address the ability of SCI patients to perform basic activities of daily living independently
- Health related quality of life - Canadian Occupational Performance Measure (COPM) [ Time Frame: Change from baseline at 6, 12, 24, 30 and 36 months post-surgery ]Evidence-based outcome measure designed to capture a patient's self-perception of performance in everyday living
- Health related quality of life - Semi-structured interviews [ Time Frame: Collected at 12 and 24 months post-surgery. ]Semi-structured interviews to gain information about satisfaction, acceptability, and the subjective experience of the surgical intervention, therapy, and functional outcome
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02861612
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|The Ottawa Hospital|
|Ottawa, Ontario, Canada, K1Y 4E9|
|Principal Investigator:||Kirsty U Boyd, MD||The Ottawa Hospital|