Is MIO-RSA Noninferior to BIO-RSA When it Comes to Mechanical Implant Stability? (CARS-2)

Lovisenberg Diakonale Hospital

Status

Enrolling

Conditions

Shoulder Osteoarthritis

Arthroplasty Complications

Treatments

Procedure: MIO-RSA

Procedure: BIO-RSA

Study type

Interventional

Funder types

Other

Identifiers

NCT06025448

CARS-2

Details and patient eligibility

About

This clinical trial will investigate whether metallic lateralization in reverse shoulder arthroplasty is as stable as bony lateralization during the first two postsurgical years, measured with CT-based motion analysis (CTMA).

Full description

Lateralization of reverse shoulder arthroplasties may reduce the risk for complications such as limited range of motion (ROM), and scapular notching, where the lower part of the scapular neck becomes eroded due to impingement against the humeral component. There's several ways to lateralize the glenoid component, a bone transplant placed underneath the glenoid component (Bony Increased Offset Reversed Shoulder Arthroplasty: BIO-RSA) has been used for some time. Recently glenoid components with metallic lateralization of the joint centre (Metal-Increased Offset Reversed Shoulder Arthroplasty: MIO-RSA) have been introduced, but there is not much comparative literature on metal vs. bony lateralization.

Patients with osteoarthritis and medialization of the glenoid articular surface, who willing to participate in a study will be randomized to receive either MIO-RSA or a BIO-RSA. CT-based motion analysis (CTMA) will be used to measure the 3-dimensional migration pattern of the glenoid components to assess the stability of the prostheses up to two years after implantation.

Enrollment

20 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
massive glenoid medialization
Able to read or write Norwegian

Exclusion criteria