Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01459536
Other study ID # 14547
Secondary ID
Status Completed
Phase N/A
First received October 21, 2011
Last updated November 3, 2017
Start date September 2011
Est. completion date December 2013

Study information

Verified date March 2017
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Wake Forest University Health Sciences Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Wake Forest University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Shoulder strength baseline
See also
  Status Clinical Trial Phase
Completed NCT03663036 - Arthroscopic Superior Capsular Reconstruction With Fascia Lata Autograft - Survivorship of the Autograft Analysis N/A
Withdrawn NCT03319784 - Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients Phase 4
Suspended NCT03290196 - The Effect of EXPAREL® on Postsurgical Pain, and the Use of Narcotics Phase 4
Active, not recruiting NCT03091075 - Oxandrolone Rotator Cuff Trial N/A
Completed NCT03380533 - Buprenorphine Transdermal Patches in Arthroscopic Rotator Cuff Repair Phase 2/Phase 3
Completed NCT04566939 - A Long Term Follow-Up of Rotator Cuff Tear Patients Treated With Integrated Complementary and Alternative Medicine
Active, not recruiting NCT02716441 - Rotator Cuff Failure With Continuity
Completed NCT03540030 - Opioid-Free Shoulder Arthroplasty Phase 4
Completed NCT02298023 - Treatment of Tendon Injury Using Allogenic Adipose-derived Mesenchymal Stem Cells (Rotator Cuff Tear) Phase 2
Completed NCT02850211 - A Selective COX-2 Inhibitor Provides Pain Control But Hinders Healing Following Arthroscopic Rotator Cuff Repair Phase 4
Completed NCT01383239 - Impact of Postoperative Management on Outcomes and Healing of Rotator Cuff Repairs N/A
Completed NCT01170312 - Arthroscopic Surgery and Platelet Rich Plasma In Rotator Cuff Tear Evaluation N/A
Terminated NCT00936559 - Study Evaluating Safety Of BMP-655/ACS As An Adjuvant Therapy For Rotator Cuff Repair Phase 1
Completed NCT01204606 - Arthroscopic Rotator Cuff Repair With Multimodal Analgesia(MMA) N/A
Completed NCT00852657 - Comparison of Tendon Repair and Physiotherapy in the Treatment of Small and Medium-sized Tears of the Rotator Cuff N/A
Active, not recruiting NCT00182299 - An RCT to Compare the Outcomes of Patients With Large Rotator Cuff Repair That Undergo Repair With or Without SIS Phase 4
Recruiting NCT06120998 - Quality of Life After Arthroscopic Rotator Cuff Repair
Completed NCT05897866 - Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management (HSSM) N/A
Completed NCT02644564 - Early Clinical Examination and Ultrasonography Screening of Acute Soft Tissue Shoulder Injuries N/A
Withdrawn NCT03739749 - Arthroscopic Superior Capsular Reconstruction - Study of Different Types of Grafts N/A