This trial is active, not recruiting.

Condition cervical spinal cord injury
Sponsor Department of Veterans Affairs
Collaborator Rehabilitation Institute of Chicago
Start date August 2011
End date December 2014
Trial size 45 participants
Trial identifier NCT01204736, B7515-R


Active elbow extension has significant functional benefits for individuals with tetraplegia. The proposed work will provide information to assess how effectively people are using their elbow extension tendon transfers, and whether one surgery works more effectively than the other. This study will provide recommendations to clinicians about the possibility of improving function after surgery using rehab techniques.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Subjects with posterior deltoid-to-triceps tendon transfers
Subjects with biceps-to-triceps tendon transfers
Subjects with cervical SCI who have not had tendon transfers
Unimpaired control subjects

Primary Outcomes

Elbow extension strength
time frame: At least one year post surgery

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title A Comparison of Two Surgical Procedures That Restore Elbow Extension
Principal investigator Wendy M Murray, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Department of Veterans Affairs.