Nerve Transfer Reconstruction in the Tetraplegic Upper Extremity

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01579604
First received: March 22, 2012
Last updated: March 21, 2014
Last verified: March 2014
  Purpose

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, quickDASH, and Capabilities of Upper Extremity Instrument (Marino, 1998) and GRASSP (Kalsi-Ryan, 2011).


Condition Intervention Phase
Tetraplegia
Plegia
Paresis
Cervical Spinal Cord Injury
Procedure: Nerve reconstruction
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early Nerve Reconstruction Approach in Tetraplegic Patients With Dysfunctional Upper Extremity: a Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Medical Research Grading (MRC) System [ Time Frame: Baseline (before surgery) ] [ Designated as safety issue: No ]
    A grading system testing the strength of muscles and ranging from grade 0 (weakest) to grade 5 (strongest).

  • Medical Research Grading (MRC) System [ Time Frame: 9 months post-op ] [ Designated as safety issue: No ]
    A grading system testing the strength of muscles and ranging from grade 0 (weakest) to grade 5 (strongest).

  • Medical Research Grading (MRC) system [ Time Frame: 12 months post-op ] [ Designated as safety issue: No ]
    A grading system testing the strength of muscles and ranging from grade 0 (weakest) to grade 5 (strongest).

  • Medical Research Grading (MRC) system [ Time Frame: 24 months post-op ] [ Designated as safety issue: No ]
    A grading system testing the strength of muscles and ranging from grade 0 (weakest) to grade 5 (strongest).


Secondary Outcome Measures:
  • Range of motion [ Time Frame: Baseline (before surgery) ] [ Designated as safety issue: No ]
    Measurement of distance and direction of a which a joint can move compared to its full potential.

  • Range of motion [ Time Frame: 9 months post-op ] [ Designated as safety issue: No ]
    Measurement of distance and direction of a which a joint can move compared to its full potential.

  • Range of motion [ Time Frame: 12 months post-op ] [ Designated as safety issue: No ]
    Measurement of distance and direction of a which a joint can move compared to its full potential.

  • Range of motion [ Time Frame: 24 months post-op ] [ Designated as safety issue: No ]
    Measurement of distance and direction of a which a joint can move compared to its full potential.

  • QuickDASH questionnaire [ Time Frame: Baseline (before surgery) ] [ Designated as safety issue: No ]
    A validated instrument used as a measure of the function of upper extremity.

  • QuickDASH questionnaire [ Time Frame: 9 months post-op ] [ Designated as safety issue: No ]
    A validated instrument used as a measure of the function of upper extremity.

  • QuickDASH questionnaire [ Time Frame: 24 months post-op ] [ Designated as safety issue: No ]
    A validated instrument used as a measure of the function of upper extremity.


Estimated Enrollment: 10
Study Start Date: June 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Surgical arm

Nerve reconstruction:

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

Procedure: 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.
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cervical spine injury with functional loss in the upper extremity
  • Greater than 6 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 6 months
  • Greater than 12 months from spinal cord injury
  • Subject not fluent in English or an appropriate translator not available
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01579604

Contacts
Contact: Sean Bristol, MD 604-875-5866 Sean.Bristol@vch.ca
Contact: Joline Choi, MBBS, MHS 604-875-4111 ext 68489 joline.choi@vch.ca

Locations
Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada
Contact: Joline Choi, MBBS, MHS    604-875-4111 ext 68489    joline.choi@vch.ca   
Sub-Investigator: Brian Kwon, MD         
Sub-Investigator: Erin Brown, MD, PhD         
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Sean Bristol, MD University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01579604     History of Changes
Other Study ID Numbers: H11-02475
Study First Received: March 22, 2012
Last Updated: March 21, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Loss of upper extremities functions
Nerve transfer

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 16, 2014