Recruiting

Nerve Transfer

Sponsor:

University of British Columbia

Code:

NCT01579604

Conditions

Tetraplegia

Plegia

Paresis

Cervical Spinal Cord Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nerve reconstruction

Study Details

Brief summary:

The cervical spine is most commonly injured, accounting for 53.4% of spinal injuries. More than 40% of all spinal injuries occur at either C4, C5 or C6 levels leading to variable loss of function in the upper extremities.

Traditionally, patients sustaining a cervical spine injury were followed for 2 years to ensure that recovery had stabilized before offering upper extremity reconstruction. This type of reconstruction includes active muscle transfer, tendon transfer and joint fusion.

Patients are most commonly assessed immediately at the time of injury. Muscle testing is commonly performed using Medical Research Grading System (MRC).

Although complete neurologic stabilization may not be complete until 2 years post-injury, in the group with initial grade 0 muscle strength after the acute phase of injury, expectations of improved muscle strength to or beyond grade 3 after 4-6 months is minimal. And grade 3 muscle strength is felt to be the minimum useful functional strength in a muscle group.

The investigators propose an early nerve reconstruction approach to the tetraplegic patient with dysfunction of the upper extremity to augment the available tendon transfers.

A comparative pilot study is proposed to determine the effectiveness of supinator branch to posterior interosseous nerve (PIN) transfer in 5 patients with cervical spine injury. Patient who fits inclusion criteria will be offered the opportunity to be involved in the study and reviewed at 6 months from injury. If the patient still has not regained Grade 3 power in finger or thumb extension, they will be randomized to be in a surgical group or non-surgical group.

If informed consent is obtained, then surgery will be completed between 6-9 months from the patient's original cervical spine injury. The patient will be followed at regular intervals post-operatively with expectation of 18-24 month follow-up.

Measures will be used pre and post-operatively for comparison. Measures will include MRC muscle grade (EDC), range of motion, Disability of the Arm, Shoulder, and Hand Questionnaire (DASH), and The Graded Redefined Assessment of Strength Sensibility and Prehension (GRASSP) (Kalsi-Ryan, 2011).

Conditions

Tetraplegia

Plegia

Paresis

Cervical Spinal Cord Injury

Study ID

NCT01579604

Start date

Jun, 2012

Status verified date

Feb, 2018

Completion date

Dec, 2019

Anticipated

Primary completion date

Dec, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Cervical spine injury with functional loss in the upper extremity
  • Greater than 4 months out from C-spine injury
  • Stable motor recovery
  • Medically stable
  • International Classification for Surgery of the Hand in Tetraplegia of 0-5 at 6 months
  • Grade 0 finger/thumb extension at 6 months
  • Subjects fluent in English or when not fluent, an appropriate translator is present

Exclusion Criteria:

  • Unstable patient
  • Joint contracture
  • Spasticity
  • Loss of function is expected to be improved by reliable tendon transfer, tenodesis or arthrodesis that is available
  • Evidence of recovering finger/thumb extension at 4-6 months
  • Greater than 12 months from spinal cord injury
  • Subject not fluent in English or an appropriate translator not available

Study Design

Enrollment

10 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Surgical arm

Nerve reconstruction:

Early nerve transfer (around 6-9 months post cervical spine injury) will be performed in this group of patients.

no intervention: Non-surgical (or observed)

Patients in this group will receive standard of care and be observed for up to two years post injury.

Interventions

Nerve reconstruction

Under general anesthetic, the surgeon will make a cut on the back (dorsal) part of the forearm. The radial nerve will be identified and specifically the branches which control the supinator muscle and the remainder of the radial nerve (Posterior interosseous nerve or PIN). . The PIN branch will be stimulated to ensure that it is non-functional. Then, the supinator branch will be stimulated to ensure it is functioning and is appropriate for transfer. If appropriate, the supinator branch will be severed and connected to the EDC branch under the operating room microscope. After the surgery, the patient will be placed into a splint including the forearm and hand for 2-3 weeks.

Primary outcome measure

  • Medical Research Grading (MRC) System [ Time Frame: Baseline (before surgery) ]
  • Medical Research Grading (MRC) System [ Time Frame: 9 months post-op ]
  • Medical Research Grading (MRC) system [ Time Frame: 12 months post-op ]
  • Medical Research Grading (MRC) system [ Time Frame: 24 months post-op ]

Central Contacts and Locations

Central contacts

Locations

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada

More Information

Sponsor

University of British Columbia

Last update posted

Feb 6, 2018

Last verified

Feb, 2018

Keywords

  • Loss of upper extremities functions
  • Nerve transfer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2018-02-06.