Actively Recruiting
From Cuff Arthropathy to Reverse Shoulder Arthroplasty - a Multicentre Randomized Control Trial Comparing BIO-RSA with Conventional RSA
Led by Lovisenberg Diakonale Hospital · Updated on 2023-11-07
130
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
L
Lovisenberg Diakonale Hospital
Lead Sponsor
H
Haukeland University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are comparing two types of reverse shoulder replacements to see which provides better shoulder function after two years. This study focuses on patients who need shoulder replacement due to conditions like osteoarthritis or rotator cuff issues. The study aims to find out if a bone transplant method, called BIO-RSA, improves outcomes compared to the conventional reverse shoulder arthroplasty (RSA). The trial involves 130 patients randomly assigned to receive either the BIO-RSA or the conventional RSA procedure. BIO-RSA includes placing a bone graft under the shoulder implant to increase joint stability and range of motion, potentially reducing complications like scapular notching. The study is blinded and conducted across multiple hospitals to compare these two surgical methods over a two-year period. Participants will have their shoulder function evaluated before surgery and at 3, 12, and 24 months afterward using patient questionnaires, physical exams by physiotherapists, and CT scans reviewed by radiologists. The main measure is the change in the Western Ontario Osteoarthritis Shoulder (WOOS) score after 24 months. Other assessments include quality of life, shoulder motion, and pain. The study will monitor participants for two years to gather comprehensive data on outcomes and complications.
CONDITIONS
Brief Title
Does BIO-RSA Provides Superior Clinical Outcome Compared to Conventional RSA?
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eligible for primary reverse shoulder arthroplasty due to osteoarthritis, massive rotator cuff tear, failed rotator cuff repair, or post-instability osteoarthritis
- Able to read or write Norwegian
- Age between 45 and 80 years
You will not qualify if you...
- Severe osteoporosis
- Osteonecrosis of the humeral head
- Dementia
- Poor deltoid muscle function
- Revision shoulder surgery
- ASA IV classification
- Suspected chronic infection
- Acute fracture
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 - 1 day
Participants undergo either BIO-RSA or conventional RSA surgery to treat shoulder conditions.
1 surgery visit
Duration - 24 months
Participants are monitored through assessments including physiotherapist examinations and CT scans to evaluate shoulder function and recovery.
Visits at 3, 12, and 24 months postoperatively
Trial Site Locations
Total: 2 locations
1
Sykehuset Telemark HF
Skien, Telemark, Norway, 3710
Not Yet Recruiting
2
Lovisenberg Diaconal Hospital
Oslo, Norway, 0456
Actively Recruiting
Research Team
K
Kjersti Kaul Jenssen, PhD
H
Hanne Fuglø, MPTh
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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