Comparing Outcomes of Elbow Extension Tendon Transfers

• ClinicalTrials.gov Identifier: NCT01204736
• Recruitment Status: Completed
• First Posted: September 17, 2010
• Results First Posted: January 7, 2016
• Last Update Posted: March 8, 2016
• Sponsor: VA Office of Research and Development
• Collaborators: Shirley Ryan AbilityLab; Northwestern University; Case Western Reserve University; Loyola University; MetroHealth System - Cleveland, OH
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

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.

Condition or disease
Cervical Spinal Cord Injury

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 Design

• Study Type: Observational
• Actual Enrollment: 14 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: A Comparison of Two Surgical Procedures That Restore Elbow Extension
• Study Start Date: August 2011
• Actual Primary Completion Date: December 2014
• Actual Study Completion Date: December 2015

Groups and Cohorts

Group/Cohort
Group 1; Subjects with posterior deltoid-to-triceps tendon transfers
Group 2; Subjects with biceps-to-triceps tendon transfers
Group 3; Subjects with cervical SCI who have not had tendon transfers
Group 4; Unimpaired control subjects

Outcome Measures

Primary Outcome Measures :

1. Elbow Extension Strength [ Time Frame: At least one year post surgery ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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

Contacts and Locations

Locations

United States, Illinois

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, United States, 60141-5000

Sponsors and Collaborators

VA Office of Research and Development

Shirley Ryan AbilityLab

Northwestern University

Case Western Reserve University

Loyola University

MetroHealth System - Cleveland, OH

Investigators

• Principal Investigator: Wendy M Murray, PhD; Edward Hines Jr. VA Hospital, Hines, IL

More Information

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01204736
• Other Study ID Numbers: B7515-R
• First Posted: September 17, 2010
• Results First Posted: January 7, 2016
• Last Update Posted: March 8, 2016
• Last Verified: February 2016

Keywords provided by VA Office of Research and Development:

tendon transfer; elbow

Additional relevant MeSH terms:

Spinal Cord Injuries; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries