Actively Recruiting
From Rotator Cuff Repair to Reverse Shoulder Arthroplasty - Clinical and Radiological Results
Led by Lovisenberg Diakonale Hospital · Updated on 2024-10-22
733
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
L
Lovisenberg Diakonale Hospital
Lead Sponsor
S
Sykehuset Telemark
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term outcomes of patients who underwent arthroscopic rotator cuff repair surgery, focusing on shoulder pain and function up to 10 years after the procedure. The study aims to fill gaps in knowledge about how many patients experience poor outcomes or develop cuff arthropathy that may require reverse shoulder arthroplasty. This large prospective cohort study involves 733 participants treated between 2010 and 2014. Participants will be invited to a 10-year follow-up where they will complete validated questionnaires including the Western Ontario Rotator Cuff Index, EQ-5D-5L, and Subjective Shoulder Value to report on their shoulder function and quality of life. The study will also include x-rays to assess the structural condition of the shoulder and signs of arthropathy using specific classification systems. The main goal is to understand how preoperative and perioperative factors influence long-term functional outcomes. During the follow-up visit, participants will provide patient-reported outcome measurements and undergo radiological evaluation. The research team will analyze these results alongside clinical data to measure rotator cuff survival and the presence of cuff arthropathy. The study is observational, with no treatment interventions at this stage, and is expected to conclude in December 2025. Participants’ involvement consists of completing questionnaires and attending x-ray imaging to help assess their shoulder status after surgery.
CONDITIONS
Brief Title
From Rotator Cuff Repair to Reverse Shoulder Arthroplasty - Clinical and Radiological Results
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Operated at Lovisenberg Diaconal Hospital between 2010 and 2014 with arthroscopic rotator cuff repair
- Included in the rotator cuff registry at Lovisenberg Diaconal Hospital
- Able to read and write Norwegian
You will not qualify if you...
- Lack of competence to consent
- Unable to submit patient reported outcome measurements or undergo x-ray
- Unwilling to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single time point at 10 years after surgery
Participants who underwent arthroscopic rotator cuff repair are observed 10 years after surgery. They provide patient reported outcome measurements and undergo x-ray evaluation.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Lovisenberg Diacolan Hospital
Oslo, Norway, 0456
Actively Recruiting
Research Team
B
Birthe Marie Roang-Winjum, MD
K
Kjersti Kaul Jenssen, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here