Nerve Transfer Reconstruction in the Tetraplegic Upper Extremity

NCT ID: NCT01579604

Last Updated: 2018-02-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2019-12-31

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).

Detailed Description

There is currently no published data showing the effect of early nerve transfer on hand function recovery of the subset of tetraplegic patients, who have initial grade 0 muscle strength immediately after their injuries. We are interested in conducting a pilot study comparing the surgical group to the non-surgical group. A larger trial will be planned if the preliminary results show positive improvement in hand function recovery.

Conditions

Tetraplegia; Plegia; Paresis; Cervical Spinal Cord Injury

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Surgical arm

Nerve reconstruction:

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

Group Type: EXPERIMENTAL

Nerve reconstruction

Intervention Type: PROCEDURE

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.

Non-surgical (or observed)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Sean Bristol

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sean Bristol, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Sean Bristol, MD

Role: CONTACT

Sean.Bristol@vch.ca

604-875-5866

Facility Contacts

Sean Bristol

Role: primary

Other Identifiers

H11-02475

Identifier Type: -

Identifier Source: org_study_id