Does BIO-RSA Provides Superior Clinical Outcome Compared to Conventional RSA? (CARS-1)

Lovisenberg Diakonale Hospital

Status: Enrolling

Conditions: Shoulder Osteoarthritis; Arthroplasty, Replacement, Shoulder

Treatments: Procedure: BIO-RSA; Procedure: RSA

Study type: Interventional

Funder types: Other

Identifiers

NCT06025331

CARS-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 estimated patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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130 participants in 2 patient groups

BIO-RSA

Experimental group

Treatment:

Procedure: BIO-RSA

RSA

Active Comparator group

Treatment:

Procedure: RSA