- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01204736
Comparing Outcomes of Elbow Extension Tendon Transfers
A Comparison of Two Surgical Procedures That Restore Elbow Extension
Study Overview
Status
Conditions
Detailed Description
Voluntary control of elbow extension significantly improves functional abilities for individuals with tetraplegia. As a result, surgical reconstruction of elbow extension via tendon transfer is considered a fundamental intervention that benefits the patient, even if other tendon transfers aimed at improving hand function are never performed. Presently, there are two common tendon transfer surgeries used to restore elbow extension following spinal cord injury. These are the posterior deltoid to triceps transfer and the biceps to triceps transfer. Both surgeries significantly improve voluntary elbow extension, although there is variability in the amount of control that is restored among patients. This study will directly compare the performance of the posterior deltoid transfer to the biceps transfer with regard to: voluntary elbow extension strength, the ability to activate the transfer, and neural factors associated with voluntary and involuntary control of individual muscles. These comparisons will be made in functionally relevant postures and will provide fundamental information that will improve clinical understanding of the capacity of each of these two procedures to restore elbow extension.
The fundamental hypothesis of this proposal is that an inability to maximally activate the transferred posterior deltoid and the transferred biceps significantly limits the elbow extension moment that can be produced.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Illinois
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Hines, Illinois, United States, 60141-5000
- Edward Hines Jr. VA Hospital, Hines, IL
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Cervical Spinal Cord Injury (C5-C7)
- Posterior Deltoid to Triceps Tendon Transfer at least one year post-surgery
- Biceps to Triceps Tendon Transfer at least one year post-surgery
Exclusion Criteria:
Subjects will be excluded from the studies if there is presence of concurrent severe medical illness, including:
- unhealed decubiti
- use of baclofen pumps
- existing infection
- cardiovascular disease
- significant osteoporosis (as indicated by a history of fractures following injury)
- or a history of pulmonary complications or autonomic dysreflexia
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Group 1
Subjects with posterior deltoid-to-triceps tendon transfers
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Group 2
Subjects with biceps-to-triceps tendon transfers
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Group 3
Subjects with cervical SCI who have not had tendon transfers
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Group 4
Unimpaired control subjects
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Elbow Extension Strength
Time Frame: At least one year post surgery
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Elbow extension strength was measured as the maximum elbow extension moment that subject's could generate.
We used an elbow moment transducer to measure elbow moments under isometric (no change in arm posture) conditions.
Subjects performed three trials at maximum effort, holding maximum elbow extension for 5 to 7 seconds.
The maximum moment was computed as the maximum average moment sustained over a 0.5 second window.
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At least one year post surgery
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Wendy M Murray, PhD, Edward Hines Jr. VA Hospital, Hines, IL
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B7515-R
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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