Clinical trial NCT01204736: Comparing Outcomes of Elbow Extension Tendon Transfers
Official title: A Comparison of Two Surgical Procedures That Restore Elbow Extension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Spinal Cord Injury
Keywords: tendon transfer
elbow
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Shirley Ryan AbilityLab
name: Northwestern University
name: Case Western Reserve University
name: Loyola University
name: MetroHealth System, Ohio
First posted: 2010-09-17
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Three groups of subjects will be recruited to participate in the experiments: individuals that have had the posterior deltoid to triceps tendon transfer, individuals that have the biceps to triceps tendon transfer, and individuals with SCI between C5-C7 who have not had tendon transfers. Nominally, we plan to recruit 15 subjects from each group.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Elbow Extension Strength
timeFrame: At least one year post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Hines
country: United States
facility: Edward Hines Jr. VA Hospital, Hines, IL
state: Illinois
Study officials:
affiliation: Edward Hines Jr. VA Hospital, Hines, IL
name: Wendy M Murray, PhD
role: PRINCIPAL_INVESTIGATOR
References: