Nerve Transfer Reconstruction in the Tetraplegic Upper Extremity

February 2, 2018 updated by: Sean Bristol, University of British Columbia

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Recruiting
        • Vancouver General Hospital
        • Contact:
          • Sean Bristol
        • Sub-Investigator:
          • Brian Kwon, MD
        • Sub-Investigator:
          • Erin Brown, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medical Research Grading (MRC) System
Time Frame: Baseline (before surgery)
A grading system testing the strength of muscles and ranging from grade 0 (weakest) to grade 5 (strongest).
Baseline (before surgery)
Medical Research Grading (MRC) System
Time Frame: 9 months post-op
A grading system testing the strength of muscles and ranging from grade 0 (weakest) to grade 5 (strongest).
9 months post-op
Medical Research Grading (MRC) system
Time Frame: 12 months post-op
A grading system testing the strength of muscles and ranging from grade 0 (weakest) to grade 5 (strongest).
12 months post-op
Medical Research Grading (MRC) system
Time Frame: 24 months post-op
A grading system testing the strength of muscles and ranging from grade 0 (weakest) to grade 5 (strongest).
24 months post-op

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of motion
Time Frame: Baseline (before surgery)
Measurement of distance and direction of a which a joint can move compared to its full potential.
Baseline (before surgery)
Range of motion
Time Frame: 9 months post-op
Measurement of distance and direction of a which a joint can move compared to its full potential.
9 months post-op
Range of motion
Time Frame: 12 months post-op
Measurement of distance and direction of a which a joint can move compared to its full potential.
12 months post-op
Range of motion
Time Frame: 24 months post-op
Measurement of distance and direction of a which a joint can move compared to its full potential.
24 months post-op
DASH questionnaire
Time Frame: Baseline (before surgery)
A validated instrument used as a measure of the function of upper extremity.
Baseline (before surgery)
DASH questionnaire
Time Frame: 9 months post-op
A validated instrument used as a measure of the function of upper extremity.
9 months post-op
DASH questionnaire
Time Frame: 24 months post-op
A validated instrument used as a measure of the function of upper extremity.
24 months post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Investigators

  • Principal Investigator: Sean Bristol, MD, University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

March 22, 2012

First Submitted That Met QC Criteria

April 16, 2012

First Posted (Estimate)

April 18, 2012

Study Record Updates

Last Update Posted (Actual)

February 6, 2018

Last Update Submitted That Met QC Criteria

February 2, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H11-02475

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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