Comparing Outcomes of Elbow Extension Tendon Transfers

NCT ID: NCT01204736

Last Updated: 2016-03-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 14 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2015-12-31

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.

Conditions

Cervical Spinal Cord Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Group 1

Subjects with posterior deltoid-to-triceps tendon transfers

No interventions assigned to this group

Group 2

Subjects with biceps-to-triceps tendon transfers

No interventions assigned to this group

Group 3

Subjects with cervical SCI who have not had tendon transfers

No interventions assigned to this group

Group 4

Unimpaired control subjects

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shirley Ryan AbilityLab

OTHER

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: collaborator

Case Western Reserve University

OTHER

Sponsor Role: collaborator

Loyola University

OTHER

Sponsor Role: collaborator

MetroHealth System, Ohio

OTHER

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wendy M Murray, PhD

Role: PRINCIPAL_INVESTIGATOR

Edward Hines Jr. VA Hospital, Hines, IL

Locations

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, United States

Countries

United States

Other Identifiers

B7515-R

Identifier Type: -

Identifier Source: org_study_id