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| Name | Class |
|---|---|
| Ontario Neurotrauma Foundation | OTHER |
| Canadian Society of Plastic Surgeons | OTHER |
| Washington University School of Medicine | OTHER |
| Rick Hansen Institute |
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This study seeks to evaluate the efficacy of nerve transfers in restoring hand function in patients with cervical spinal injuries.
Cervical spinal cord injury is a life-altering injury that results in profound loss of upper limb function. Hand function is essential to basic activities of daily living and consequently has a significant impact on patients' quality of life. Tendon transfers and/or tenodesis have traditionally been used to restore hand function in spinal cord injuries - however, in recent years there is growing interest in the role of nerve transfers as a means of accomplishing this goal. Although preliminary results indicate nerve transfers may be well-suited for patients with spinal cord injury, their long term efficacy has not been demonstrated.
This study seeks to evaluate the efficacy of nerve transfers in restoring hand function in patients with cervical spinal injuries. Eligible patients will receive nerve transfer procedure(s) (e.g. brachialis to anterior interosseous nerve, supinator to posterior interosseous) and will be followed post-operatively to assess for changes in strength, functional independence, and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nerve Transfer | This is an observational study that looks at function and quality of life in patients before and after nerve transfer surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nerve Transfer Surgery | Procedure | Unilateral surgery will be performed under general non-paralytic anesthesia and no-tourniquet conditions to allow for responsive nerve simulation. |
| Measure | Description | Time Frame |
|---|---|---|
| Upper extremity function - Myometric measures of strength (donor and recipient muscle groups) | Valid and reliable quantitative muscle strength measurement | Change from baseline at 6, 12, 24, 30 and 36 months post-surgery |
| Upper extremity function - Manual muscle testing (MRC) | Quantitative assessment of motor function (MRC) | Change from baseline at 6, 12, 24, 30 and 36 months post-surgery |
| Upper extremity function - Graded Redefined Assessment of Strength, Sensibility and Prehension test (GRASSP) | Valid, reliable and responsive measure of sensorimotor upper limb impairment specifically designed for patients with cervical SCI | Change from baseline at 6, 12, 24, 30 and 36 months post-surgery |
| Upper extremity function - Range of motion | Quantitative assessment of range of motion (degrees) | Change from baseline at 6, 12, 24, 30 and 36 months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Health related quality of life - The Short Form (SF)-36 | Valid and responsive measure of quality of life in surgical patients | Change from baseline at 6, 12, 24, 30 and 36 months post-surgery |
| Health related quality of life - Spinal Cord Independence Measure (SCIM I) |
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Inclusion Criteria:
Exclusion Criteria:
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Any patients with cervical spinal cord injury and upper extremity dysfunction who are medically stable, residents of Canada, willing and able to be assessed at the The Ottawa Hospital are potential participants.
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| Name | Affiliation | Role |
|---|---|---|
| Kirsty U Boyd, MD | The Ottawa Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States | ||
| The Ottawa Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26397252 | Background | Fox IK, Davidge KM, Novak CB, Hoben G, Kahn LC, Juknis N, Ruvinskaya R, Mackinnon SE. Nerve Transfers to Restore Upper Extremity Function in Cervical Spinal Cord Injury: Update and Preliminary Outcomes. Plast Reconstr Surg. 2015 Oct;136(4):780-792. doi: 10.1097/PRS.0000000000001641. | |
| 25767422 | Background | Fox IK, Davidge KM, Novak CB, Hoben G, Kahn LC, Juknis N, Ruvinskaya R, Mackinnon SE. Use of peripheral nerve transfers in tetraplegia: evaluation of feasibility and morbidity. Hand (N Y). 2015 Mar;10(1):60-7. doi: 10.1007/s11552-014-9677-z. |
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| ID | Term |
|---|---|
| D011782 | Quadriplegia |
| D013118 | Spinal Cord Diseases |
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| OTHER |
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Disability scale developed to specifically address the ability of SCI patients to perform basic activities of daily living independently |
| Change from baseline at 6, 12, 24, 30 and 36 months post-surgery |
| Health related quality of life - Canadian Occupational Performance Measure (COPM) | Evidence-based outcome measure designed to capture a patient's self-perception of performance in everyday living | Change from baseline at 6, 12, 24, 30 and 36 months post-surgery |
| Health related quality of life - Semi-structured interviews | Semi-structured interviews to gain information about satisfaction, acceptability, and the subjective experience of the surgical intervention, therapy, and functional outcome | Collected at 12 and 24 months post-surgery. |
| Ottawa |
| Ontario |
| K1Y 4E9 |
| Canada |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D002493 | Central Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |