TetraplegiaPhase 4NCT01579604
Nerve Transfer Reconstruction in the Tetraplegic Upper Extremity
A Phase 4 study testing Nerve reconstruction in people with Tetraplegia and Plegia, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tetraplegia, Plegia, Paresis
- What is being tested?
- Nerve reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2012to Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia
Sean Bristol
Brian Kwon, MD
About this study
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.
Read more
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).
Read the 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.
- Conditions
- Tetraplegia, Plegia, Paresis, Cervical Spinal Cord Injury
- Being tested
- Nerve reconstruction
- Keywords
- Loss of upper extremities functions, Nerve transfer
- Medical subject headings
- Quadriplegia, Paralysis, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve reconstructionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Surgical arm | Experimental | Nerve reconstruction:
Early nerve transfer (around 6-9 months post cervical spine injury) will be performed in this group of patients. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical Research Grading (MRC) System
A grading system testing the strength of muscles and ranging from grade 0 (weakest) to grade 5 (strongest).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 24 months post-op
Secondary outcomes (7)
Range of motion
Measurement of distance and direction of a which a joint can move compared to its full potential.
Measured: Baseline (before surgery)
Range of motion
Measurement of distance and direction of a which a joint can move compared to its full potential.
Measured: 9 months post-op
Range of motion
Measurement of distance and direction of a which a joint can move compared to its full potential.
Measured: 12 months post-op
Range of motion
Measurement of distance and direction of a which a joint can move compared to its full potential.
Measured: 24 months post-op
DASH questionnaire
A validated instrument used as a measure of the function of upper extremity.
Measured: Baseline (before surgery)
DASH questionnaire
A validated instrument used as a measure of the function of upper extremity.
Measured: 9 months post-op
DASH questionnaire
A validated instrument used as a measure of the function of upper extremity.
Measured: 24 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TetraplegiaStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sean Bristol, University of British Columbia
- Investigators
- Sean Bristol, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01579604
- Sponsor's protocol ID
- H11-02475
- Status last verified
- Feb 2018
- First submitted
- 22 Mar 2012
- Last updated
- 6 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Nerve Reconstruction Approach in Tetraplegic Patients With Dysfunctional Upper Extremity: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01579604
- Acronym / sponsor ID
- H11-02475
- Conditions
- Tetraplegia, Plegia, Paresis, Cervical Spinal Cord Injury
- Keywords
- Loss of upper extremities functions, Nerve transfer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 18 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical arm | Experimental | Procedure: Nerve reconstructionNerve reconstruction: Early nerve transfer (around 6-9 months post cervical spine injury) will be performed in this group of patients. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nerve reconstructionUnder 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. | Procedure or surgery | Surgical arm |
Primary outcome
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).
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).
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).
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).
7 secondary outcomes
Range of motion
Time frame: Baseline (before surgery)
Range of motion
Time frame: 9 months post-op
Range of motion
Time frame: 12 months post-op
Range of motion
Time frame: 24 months post-op
DASH questionnaire
Time frame: Baseline (before surgery)
DASH questionnaire
Time frame: 9 months post-op
DASH questionnaire
Time frame: 24 months post-op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean Bristol, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nerve reconstruction in people with Tetraplegia and Plegia, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sean Bristol, MD (604-875-5866, Sean.Bristol@vch.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medical Research Grading (MRC) System (time frame: Baseline (before surgery)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2018; AzTrials last refreshed its copy on 2 Nov 2026.