Examining shoulder muscle health after total shoulder replacement
Evaluation of Structural and Functional Integrity of the Rotator Cuff After Total Shoulder Arthroplasty
This study is testing the health of shoulder muscles in people who have had shoulder replacement surgery to see how well they are doing one and two years later.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | Milton S. Hershey Medical Center Academic / other |
| Locations | 1 site (Hershey, Pennsylvania) |
| Trial ID | NCT03921944 on ClinicalTrials.gov |
What this trial studies
This study evaluates the structural and functional integrity of the rotator cuff muscles in patients who have undergone total shoulder arthroplasty due to osteoarthritis. Participants will undergo CT scans of their shoulders at one and two years post-surgery to assess the condition of their rotator cuff. The study aims to gather data that could inform future treatment and rehabilitation strategies for shoulder surgery patients.
Who should consider this trial
Good fit: Ideal candidates are individuals over 45 years old with a primary diagnosis of shoulder osteoarthritis who have had total shoulder replacement surgery performed by Dr. Armstrong.
Not a fit: Patients with recent shoulder trauma, atypical shoulder pain, or other shoulder pathologies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of rotator cuff health after shoulder replacement surgery.
How similar studies have performed: While there may be studies on shoulder surgery outcomes, this specific evaluation of rotator cuff integrity post-surgery is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age \>45yrs * primary diagnosis of osteoarthritis of the shoulder * total shoulder replacement performed by Dr. Armstrong * administered a local anesthetic mixture and not regional anesthesia * all genders * Fluent in written and spoken English * Patients capable of giving informed consent Exclusion Criteria: * Known contraindications to CT/EMG * Inability to provide informed consent * History of recent trauma to the shoulder * Atypical shoulder pain * Other suspected shoulder pathology (i.e. tumor, infection) * Pregnancy * Bilateral total shoulder arthroplasty
Where this trial is running
Hershey, Pennsylvania
- Penn State Hershey Medical Center — Hershey, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: April D Armstrong, MD — Milton S. Hershey Medical Center
- Study coordinator: Padmavathi Ponnuru, PhD
- Email: pponnuru@pennstatehealth.psu.edu
- Phone: 717-531-0003
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.