Comparing Outcomes of Elbow Extension Tendon Transfers

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.

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Key information

Conditions

Cervical Spinal Cord Injury

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141-5000, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

Case Western Reserve University
Loyola University
MetroHealth System, Ohio
Northwestern University
Shirley Ryan AbilityLab

Registry information

Official study title

A Comparison of Two Surgical Procedures That Restore Elbow Extension

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2015
First posted: Sep 17, 2010
Registry last updated: Mar 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed