From Rotator Cuff Repair to Reverse Shoulder Arthroplasty - Clinical and Radiological Results
- Sponsor
- Lovisenberg Diakonale Hospital
- Study ID
- NCT06644729
- Status
- Recruiting
Conditions
- Rotator Cuff Injuries
- Rotator Cuff Tear Arthropathy
- Rotator Cuff Tears
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 95 Years
- Healthy Volunteers
- Not accepted
Interventions
- Arthroscopic Rotator Cuff Repair — PROCEDUREArthroscopic Rotator Cuff Repair
Study Details
In the planned study the investigators will invite 733 participants 10 years after arthroscopic rotator cuff repair to a follow up examination. Shoulder pain is a common problem in the Norwegian population. Rotator cuff tear is a major cause of shoulder pain with a reported prevalence of up to 51% in patients 60-80 years of age. Arthroscopic rotator cuff repair is performed in an increasing proportion of these patients. Good results in shoulder function has been reported, although there is a lack in published good quality studies and long term follow up of these patients. There is also a lack of evidence regarding the association between radiologically-verified re-tear and clinical outcome. In this project, the investigators address these critical gaps in knowledge and aim to investigate the factors influencing the clinical outcome after rotator cuff surgery and re-tear in a large prospective cohort study. The investigators will investigate how many participants suffering from poor outcome and develop cuff arthropathy in need of reverse shoulder arthroplasty after 10 years.
Key Dates
- First listed
- Oct 16, 2024
- Start date
- Sep 11, 2024
- Status verified
- Oct 2024
- Primary completion
- Dec 31, 2025
- Completion
- Dec 31, 2025
Study Design
- Enrollment
- 733 participants (estimated)
Arms
- Arm: Cohort 10 years after surgeryCohort of 733 participants will be invited to a 10 year follow up and will be evaluated with patient reported outcome measurements and x-ray.
Primary Outcome Measure
Western Ontario Rotator Cuff Index, Norwegian Version [ Time Frame: 10 Years after surgery ]
Central Contacts
- Birthe Marie Roang-Winjum, MD0047 90665939
- Kjersti Kaul Jenssen, MD, PhD0047 91392624
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