NCT01579604

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2012

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2012

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 18, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 6, 2018

Status Verified

February 1, 2018

Enrollment Period

7.5 years

First QC Date

March 22, 2012

Last Update Submit

February 2, 2018

Conditions

TetraplegiaPlegiaParesisCervical Spinal Cord Injury

Keywords

Loss of upper extremities functionsNerve transfer

Outcome Measures

Primary Outcomes (4)

  • 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)

  • 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

  • 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

  • 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 Outcomes (7)

  • Range of motion

    Baseline (before surgery)

  • Range of motion

    9 months post-op

  • Range of motion

    12 months post-op

  • Range of motion

    24 months post-op

  • DASH questionnaire

    Baseline (before surgery)

  • +2 more secondary outcomes

Study Arms (2)

Surgical arm

EXPERIMENTAL

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

Procedure: Nerve reconstruction

Non-surgical (or observed)

NO INTERVENTION

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

Interventions

Nerve reconstructionPROCEDURE

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.

Surgical arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, Canada

RECRUITING

MeSH Terms

Conditions

QuadriplegiaParalysisParesis

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sean Bristol, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sean Bristol, MD

CONTACT

604-875-5866Sean.Bristol@vch.ca

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 22, 2012

First Posted

April 18, 2012

Study Start

June 1, 2012

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

February 6, 2018

Record last verified: 2018-02

Locations

CA(1)