Clinical trial NCT02861612: Nerve Transfers to Restore Hand Function in Spinal Cord Injury
Official title: Nerve Transfers to Restore Hand Function in Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Quadriplegia
Spinal Cord Diseases
Spinal Cord Injuries
Keywords: peripheral nerves
quadriplegia
nerve transfer
surgical procedures, operative
hand
upper extremity
quality of life
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Ontario Neurotrauma Foundation
name: Canadian Society of Plastic Surgeons
name: Washington University School of Medicine
name: Rick Hansen Institute
First posted: 2016-08-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patients with cervical spinal cord injury and upper extremity dysfunction who are medically stable, residents of Canada, willing and able to be assessed at the The Ottawa Hospital are potential participants.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Upper extremity function - Myometric measures of strength (donor and recipient muscle groups)
timeFrame: Change from baseline at 6, 12, 24, 30 and 36 months post-surgery
measure: Upper extremity function - Manual muscle testing (MRC)
timeFrame: Change from baseline at 6, 12, 24, 30 and 36 months post-surgery
measure: Upper extremity function - Graded Redefined Assessment of Strength, Sensibility and Prehension test (GRASSP)
timeFrame: Change from baseline at 6, 12, 24, 30 and 36 months post-surgery
measure: Upper extremity function - Range of motion
timeFrame: Change from baseline at 6, 12, 24, 30 and 36 months post-surgery
Secondary outcomes:
measure: Health related quality of life - The Short Form (SF)-36
timeFrame: Change from baseline at 6, 12, 24, 30 and 36 months post-surgery
measure: Health related quality of life - Spinal Cord Independence Measure (SCIM I)
timeFrame: Change from baseline at 6, 12, 24, 30 and 36 months post-surgery
measure: Health related quality of life - Canadian Occupational Performance Measure (COPM)
timeFrame: Change from baseline at 6, 12, 24, 30 and 36 months post-surgery
measure: Health related quality of life - Semi-structured interviews
timeFrame: Collected at 12 and 24 months post-surgery.
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: Kirsty U Boyd, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fox IK, Davidge KM, Novak CB, Hoben G, Kahn LC, Juknis N, Ruvinskaya R, Mackinnon SE. Nerve Transfers to Restore Upper Extremity Function in Cervical Spinal Cord Injury: Update and Preliminary Outcomes. Plast Reconstr Surg. 2015 Oct;136(4):780-792. doi: 10.1097/PRS.0000000000001641.
citation: Fox IK, Davidge KM, Novak CB, Hoben G, Kahn LC, Juknis N, Ruvinskaya R, Mackinnon SE. Use of peripheral nerve transfers in tetraplegia: evaluation of feasibility and morbidity. Hand (N Y). 2015 Mar;10(1):60-7. doi: 10.1007/s11552-014-9677-z.