Clinical trial NCT01579604: Nerve Transfer Reconstruction in the Tetraplegic Upper Extremity
Official title: Early Nerve Reconstruction Approach in Tetraplegic Patients With Dysfunctional Upper Extremity: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Tetraplegia
Plegia
Paresis
Cervical Spinal Cord Injury
Keywords: Loss of upper extremities functions
Nerve transfer
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2012-04-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Medical Research Grading (MRC) System
timeFrame: Baseline (before surgery)
measure: Medical Research Grading (MRC) System
timeFrame: 9 months post-op
measure: Medical Research Grading (MRC) system
timeFrame: 12 months post-op
measure: Medical Research Grading (MRC) system
timeFrame: 24 months post-op
Secondary outcomes:
measure: Range of motion
timeFrame: Baseline (before surgery)
measure: Range of motion
timeFrame: 9 months post-op
measure: Range of motion
timeFrame: 12 months post-op
measure: Range of motion
timeFrame: 24 months post-op
measure: DASH questionnaire
timeFrame: Baseline (before surgery)
measure: DASH questionnaire
timeFrame: 9 months post-op
measure: DASH questionnaire
timeFrame: 24 months post-op
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Sean Bristol, MD
role: PRINCIPAL_INVESTIGATOR
References: