Does BIO-RSA Provides Superior Clinical Outcome Compared to Conventional RSA?
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BIO-RSA, RSA.
- Who it may be relevant to
- Registry conditions: Arthroplasty, Replacement, Shoulder, Shoulder Osteoarthritis. Basic parameters: 45 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
From Cuff Arthropathy to Reverse Shoulder Arthroplasty - a Multicentre Randomized Control Trial (Study 1: Does BIO-RSA Provides Superior Clinical Outcome Compared to Conventional RSA?).
Overview
The goal of this clinical trial is to compare two different types of reverse shoulder replacements. Researchers will compare a conventional reverse shoulder replacement with a lateralized reverse shoulder replacement to see if there is a difference in how well the patients function after two years.
Detailed description
Many studies have showed pain relief and improvement in shoulder function following reverse shoulder arthroplasty (RSA), but medialization of the centre of rotation (COR) in RSA may cause complications like limited range of motion (ROM), luxation of the prosthesis, and scapular notching, where the lower part of the scapular neck becomes eroded due to impingement against the humeral component. Joint centre lateralization with a bone transplant placed underneath the glenoid component (BIO-RSA) was introduced to maximize ROM in the prosthetic joint, increase stability and to prevent scapular notching. In recent years it has been claimed that lateralization of the COR with BIO-RSA decreases the risk of the aforementioned complication, but no consensus on when or how to lateralize the COR exists as of today. This knowledge will also be of critical importance when it comes to decision making on how these patients are best treated. Results from this research project is expected to have a significant impact on how these patients are treated in the future, both nationally and internationally.
The purpose of this study is to compare functional results between patients with bony increased offset-reversed shoulder arthroplasty (BIO-RSA) and conventional reverse shoulder arthroplasty (RSA) to investigate if lateralization of the glenosphere yields superior outcomes and fewer complications after 2 years.
This multicenter study will include 130 patients in 4 hospitals scheduled for RSA. Patients will be asked to participate in a blinded RCT, where they are randomly assigned to either BIO-RSA or conventional RSA. Functional results will be measured primarily by the patient-reported outcome measure Western Ontario Osteoarthritis Shoulder (WOOS), but they will also be examined by a physiotherapist and CT imagery will be assessed by a radiologist.
Interventions
- Procedure BIO-RSA
Bony increased offset-reversed shoulder arthroplasty(BIO-RSA) will be performed. - Procedure RSA
Conventional reversed shoulder arthroplasty(RSA) will be performed.
Primary outcome measures
- Change in WOOS index from baseline to 24 months postoperatively. [Time frame: Before randomization, 24 months postoperatively. Also measured 3 and 12 months postoperatively. Change after 24 months will be the primary outcome.]
Secondary outcome measures (7)
- Change in EuroQol-5 from baseline to 24 months postoperatively. [Time frame: Before randomization, 3, 12 and 24 months postoperatively.]
- CT scan [Time frame: Before randomization, 3, 12 and 24 months postoperatively.]
- Change in Constant-Murley Score from baseline to 24 months postoperatively. [Time frame: Before randomization, 3, 12 and 24 months postoperatively.]
- Change in range of motion from baseline to 24 months postoperatively. [Time frame: Before randomization, 3, 12 and 24 months postoperatively.]
- Change in Subjective Shoulder Value from baseline to 24 months postoperatively. [Time frame: Before randomization, 3, 12 and 24 months postoperatively.]
- Anchor question 1 [Time frame: Before randomization, 3, 12 and 24 months postoperatively.]
- Anchor question 2 [Time frame: 3, 12 and 24 months postoperatively.]
Eligibility criteria
Inclusion criteria
- Eligible for primary RSA due to OA, massive RC tear, failed RC repair or post-instability osteoarthritis
- Able to read or write Norwegian
Exclusion criteria
- Severe osteoporosis
- Osteonecrosis of the humeral head
- Dementia
- Poor deltoid function
- Revision surgery
- ASA IV
- Suspected chronic infection
- Acute fracture
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Norway · 2 centers
- Sykehuset Telemark HF — Skien
- Lovisenberg Diaconal Hospital — Oslo
Identifiers
NCT: NCT06025331 · CARS-1