Overview

This trial is active, not recruiting.

Condition rotator cuff tear
Sponsor Wake Forest School of Medicine
Start date September 2011
End date December 2013
Trial size 50 participants
Trial identifier NCT01459536, 14547

Summary

Adequate upper limb function is critically important to maintenance of independence and prevention of disability in older adults. The goal of this work is to identify factors that contribute to rotator cuff rupture and improved outcomes for repair. Ultimately, the investigators seek to identify patients most at risk for rupture and to guide clinicians on optimal surgical and rehabilitation strategies. This pilot study will quantitatively characterize the morphological (muscle volume and fatty infiltration) and functional (shoulder isometric joint strength, movement when performing typical task) changes in the muscles of the rotator cuff following supraspinatus tear and surgical repair. The investigators hypothesize that patients with supraspinatus tear will have reduced muscle volume and increased fatty infiltration of rotator cuff muscles compared to their contralateral arm and age-matched controls, which will increase following surgery. The investigators further hypothesize that isometric joint strength in these individuals will be associated with muscle volume and the degree of fatty infiltration, and that older adults with a rotator cuff tear will use a restricted range of motion to accomplish functional tasks. This study emphasizes muscle function and composition with application to rehabilitation of upper limb function, which complements the theme of the Pepper Center.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm

Primary Outcomes

Measure
Shoulder strength
time frame: baseline

Eligibility Criteria

Male or female participants at least 60 years old.

Inclusion Criteria: - adults ≥ 60 years of age - free of any medical condition that might be exacerbated by physical testing - patients: major thickness supraspinatus tear - control subjects: no history of significant injury or pathology in either upper limb Exclusion Criteria: - contraindication to undergoing MRI - history of neuromuscular disorder, or any injury that may affect the upper limb (e.g. any history of stroke, Parkinson's, or spinal cord injury, or being confined to a wheelchair)

Additional Information

Official title Rotator Cuff Function and Muscle Morphology in Older Adults With Rotator Cuff Tear
Principal investigator Katherine Saul, PhD
Trial information was received from ClinicalTrials.gov and was last updated in July 2013.
Information provided to ClinicalTrials.gov by Wake Forest School of Medicine.