Tetraplegia Clinical Trial
Official title:
Early Nerve Reconstruction Approach in Tetraplegic Patients With Dysfunctional Upper Extremity: a Randomized Controlled Trial.
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).
Status | Recruiting |
Enrollment | 10 |
Est. completion date | December 2019 |
Est. primary completion date | December 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Vancouver General Hospital | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Medical Research Grading (MRC) System | A grading system testing the strength of muscles and ranging from grade 0 (weakest) to grade 5 (strongest). | Baseline (before surgery) | |
Primary | Medical Research Grading (MRC) System | A grading system testing the strength of muscles and ranging from grade 0 (weakest) to grade 5 (strongest). | 9 months post-op | |
Primary | Medical Research Grading (MRC) system | A grading system testing the strength of muscles and ranging from grade 0 (weakest) to grade 5 (strongest). | 12 months post-op | |
Primary | Medical Research Grading (MRC) system | A grading system testing the strength of muscles and ranging from grade 0 (weakest) to grade 5 (strongest). | 24 months post-op | |
Secondary | Range of motion | Measurement of distance and direction of a which a joint can move compared to its full potential. | Baseline (before surgery) | |
Secondary | Range of motion | Measurement of distance and direction of a which a joint can move compared to its full potential. | 9 months post-op | |
Secondary | Range of motion | Measurement of distance and direction of a which a joint can move compared to its full potential. | 12 months post-op | |
Secondary | Range of motion | Measurement of distance and direction of a which a joint can move compared to its full potential. | 24 months post-op | |
Secondary | DASH questionnaire | A validated instrument used as a measure of the function of upper extremity. | Baseline (before surgery) | |
Secondary | DASH questionnaire | A validated instrument used as a measure of the function of upper extremity. | 9 months post-op | |
Secondary | DASH questionnaire | A validated instrument used as a measure of the function of upper extremity. | 24 months post-op |
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