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Recruiting NCT06025448

Is MIO-RSA Noninferior to BIO-RSA When it Comes to Mechanical Implant Stability?

No phase Interventional Arthroplasty Complications Shoulder Osteoarthritis

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, MIO-RSA.
Who it may be relevant to
Registry conditions: Arthroplasty Complications, 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 (CARS 2: Is MIO-RSA Noninferior to BIO-RSA When it Comes to Mechanical Implant Stability Measured With CT-based Motion Analysis (CTMA)?).

Overview

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).

Detailed 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.

Interventions

  • Procedure BIO-RSA
    Patients will have a reversed shoulder arthroplasty with lateralization of the joint centre using bony lateralization (BIO-RSA).
  • Procedure MIO-RSA
    Patients will have a reversed shoulder arthroplasty with lateralization of the joint centre using metallic lateralization (MIO-RSA).

Primary outcome measures

  • Migration of glenoid component from baseline until 24 months [Time frame: At baseline and 3, 6, 12 and 24 months postoperatively. 24 months will be the primary outcome.]
Secondary outcome measures (7)
  • Change in WOOS Index [Time frame: Before randomization, 3, 12 and 24 months postoperatively.]
  • Change in Constant-Murley Score [Time frame: Before randomization, 3, 12 and 24 months postoperatively.]
  • Change in EuroQol-5 [Time frame: Before randomization, 3, 12 and 24 months postoperatively.]
  • Change in range of motion [Time frame: Before randomization, 3, 12 and 24 months postoperatively.]
  • Change in Subjective Shoulder Value [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
  • massive glenoid medialization
  • 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 · 1 center
  • Lovisenberg Diaconal Hospital — Oslo

Identifiers

NCT: NCT06025448 · CARS-2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗