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Nerve Transfer Reconstruction in the Tetraplegic Upper Extremity

Primary Purpose

Tetraplegia, Plegia, Paresis

Status
Unknown status
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Nerve reconstruction
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tetraplegia focused on measuring Loss of upper extremities functions, Nerve transfer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vancouver General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Surgical arm

Non-surgical (or observed)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Medical Research Grading (MRC) System
A grading system testing the strength of muscles and ranging from grade 0 (weakest) to grade 5 (strongest).
Medical Research Grading (MRC) System
A grading system testing the strength of muscles and ranging from grade 0 (weakest) to grade 5 (strongest).
Medical Research Grading (MRC) system
A grading system testing the strength of muscles and ranging from grade 0 (weakest) to grade 5 (strongest).
Medical Research Grading (MRC) system
A grading system testing the strength of muscles and ranging from grade 0 (weakest) to grade 5 (strongest).

Secondary Outcome Measures

Range of motion
Measurement of distance and direction of a which a joint can move compared to its full potential.
Range of motion
Measurement of distance and direction of a which a joint can move compared to its full potential.
Range of motion
Measurement of distance and direction of a which a joint can move compared to its full potential.
Range of motion
Measurement of distance and direction of a which a joint can move compared to its full potential.
DASH questionnaire
A validated instrument used as a measure of the function of upper extremity.
DASH questionnaire
A validated instrument used as a measure of the function of upper extremity.
DASH questionnaire
A validated instrument used as a measure of the function of upper extremity.

Full Information

First Posted
March 22, 2012
Last Updated
February 2, 2018
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT01579604
Brief Title
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

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tetraplegia, Plegia, Paresis, Cervical Spinal Cord Injury
Keywords
Loss of upper extremities functions, Nerve transfer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgical arm
Arm Type
Experimental
Arm Description
Nerve reconstruction: Early nerve transfer (around 6-9 months post cervical spine injury) will be performed in this group of patients.
Arm Title
Non-surgical (or observed)
Arm Type
No Intervention
Arm Description
Patients in this group will receive standard of care and be observed for up to two years post injury.
Intervention Type
Procedure
Intervention Name(s)
Nerve reconstruction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Medical Research Grading (MRC) System
Description
A grading system testing the strength of muscles and ranging from grade 0 (weakest) to grade 5 (strongest).
Time Frame
Baseline (before surgery)
Title
Medical Research Grading (MRC) System
Description
A grading system testing the strength of muscles and ranging from grade 0 (weakest) to grade 5 (strongest).
Time Frame
9 months post-op
Title
Medical Research Grading (MRC) system
Description
A grading system testing the strength of muscles and ranging from grade 0 (weakest) to grade 5 (strongest).
Time Frame
12 months post-op
Title
Medical Research Grading (MRC) system
Description
A grading system testing the strength of muscles and ranging from grade 0 (weakest) to grade 5 (strongest).
Time Frame
24 months post-op
Secondary Outcome Measure Information:
Title
Range of motion
Description
Measurement of distance and direction of a which a joint can move compared to its full potential.
Time Frame
Baseline (before surgery)
Title
Range of motion
Description
Measurement of distance and direction of a which a joint can move compared to its full potential.
Time Frame
9 months post-op
Title
Range of motion
Description
Measurement of distance and direction of a which a joint can move compared to its full potential.
Time Frame
12 months post-op
Title
Range of motion
Description
Measurement of distance and direction of a which a joint can move compared to its full potential.
Time Frame
24 months post-op
Title
DASH questionnaire
Description
A validated instrument used as a measure of the function of upper extremity.
Time Frame
Baseline (before surgery)
Title
DASH questionnaire
Description
A validated instrument used as a measure of the function of upper extremity.
Time Frame
9 months post-op
Title
DASH questionnaire
Description
A validated instrument used as a measure of the function of upper extremity.
Time Frame
24 months post-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sean Bristol, MD
Phone
604-875-5866
Email
Sean.Bristol@vch.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean Bristol, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sean Bristol
First Name & Middle Initial & Last Name & Degree
Brian Kwon, MD
First Name & Middle Initial & Last Name & Degree
Erin Brown, MD, PhD

12. IPD Sharing Statement

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Nerve Transfer Reconstruction in the Tetraplegic Upper Extremity

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