Comparing Outcomes of Elbow Extension Tendon Transfers

NCT01204736 | Completed Results

• 1 other identifier: B7515-R
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Spinal Cord Injury

Keywords

tendon transfer; elbow

Outcome Measures

Primary Outcomes (1)

• Elbow Extension Strength

  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.

  At least one year post surgery

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Shirley Ryan AbilityLab: collaborator
• Northwestern University: collaborator
• Case Western Reserve University: collaborator
• Loyola University: collaborator
• MetroHealth System, Ohio: collaborator

Study Sites (1)

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141-5000, United States

Location

Results Point of Contact

• Title: Dr. Wendy Murray
• Organization: Rehabilitation Institute of Chicago

w-murray@northwestern.edu

3122386965

Study Officials

• Wendy M Murray, PhD

  Edward Hines Jr. VA Hospital, Hines, IL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2010
• First Posted: September 17, 2010
• Study Start: August 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: March 8, 2016
• Results First Posted: January 7, 2016

Record last verified: 2016-02

Locations

US (1)