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Comparing Outcomes of Elbow Extension Tendon Transfers

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Department of Veterans Affairs
Sponsor:
Collaborators:
Rehabilitation Institute of Chicago
Northwestern University
Case Western Reserve University
Loyola University
MetroHealth System - Cleveland, OH
Shriners Hospitals for Children - Chicago
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01204736
First received: September 15, 2010
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

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
Cervical Spinal Cord Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Comparison of Two Surgical Procedures That Restore Elbow Extension

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Elbow extension strength [ Time Frame: At least one year post surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: August 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01204736

Contacts
Contact: Carrie Peterson (312) 238-1416 cpeterson@ric.org
Contact: Wendy M Murray, PhD (708) 202-8387 ext 25691 Wendy.Murray@va.gov

Locations
United States, Illinois
Edward Hines, Jr. VA Hospital Recruiting
Hines, Illinois, United States, 60141-5000
Contact: Carrie Peterson    312-238-1416    cpeterson@ric.org   
Principal Investigator: Wendy M Murray, PhD         
Sponsors and Collaborators
Rehabilitation Institute of Chicago
Northwestern University
Case Western Reserve University
Loyola University
MetroHealth System - Cleveland, OH
Shriners Hospitals for Children - Chicago
Investigators
Principal Investigator: Wendy M Murray, PhD Edward Hines Jr. VA Hospital
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01204736     History of Changes
Other Study ID Numbers: B7515-R
Study First Received: September 15, 2010
Last Updated: June 16, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
tendon transfer
elbow

Additional relevant MeSH terms:
Spinal Cord Injuries
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on November 27, 2014