Quadriplegia, Spinal Cord Diseases, Spinal Cord Injuries
Conditions
Keywords
peripheral nerves, quadriplegia, nerve transfer, surgical procedures, operative, hand, upper extremity, quality of life
Brief summary
This study seeks to evaluate the efficacy of nerve transfers in restoring hand function in patients with cervical spinal injuries.
Detailed description
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.
Interventions
PROCEDURENerve Transfer Surgery
Unilateral surgery will be performed under general non-paralytic anesthesia and no-tourniquet conditions to allow for responsive nerve simulation.
Sponsors
Ontario Neurotrauma Foundation
Canadian Society of Plastic Surgeons
Washington University School of Medicine
Rick Hansen Institute
Ottawa Hospital Research Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients with a spinal cord injury AIS level C5 to C7. Those with motor complete injuries (AIS A or B) will be considered for surgical intervention if they are ≥ 5 months post injury. Motor incomplete patients (AIS C or D) will be considered if they are ≥ 1.5 years post injury. * Patients will require ≥ MRC 4 strength of the muscle supplied by the donor nerve (e.g. brachialis, supinator). * Finger flexor and extensor strength should be ≤ MRC 1 strength. * Muscles supplied by the donor nerve, will need to have no or minimal of evidence of lower motor neuron injury as dictated by evidence of fibrillations, positive sharp waves, or moderate or severely decreased recruitment on needle electromyography. * Those being evaluated for surgery outside nine-months post injury recipient muscles will be required to be free of lower motor neuron pathology. * Ability to comply and participate in rigorous post-surgical therapy regimen.
Exclusion criteria
* Comorbidities precluding safe surgery including autonomic/hemodynamic instability, pulmonary instability, active infection, chronic pressure sores or untreated urinary tract infections as determined by physician. * Simultaneous tendon transfer or tenodesis surgery (which would preclude separation of the effect of nerve transfer alone).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Upper extremity function - Range of motion | Change from baseline at 6, 12, 24, 30 and 36 months post-surgery | Quantitative assessment of range of motion (degrees) |
| Upper extremity function - Myometric measures of strength (donor and recipient muscle groups) | 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) | 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) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health related quality of life - The Short Form (SF)-36 | 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) | 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) | 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 | 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 |
Countries
Canada, United States
Outcome results
None listed