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
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Arthroplasty Complications
- Sponsor
- Lovisenberg Diakonale Hospital
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Migration of glenoid component from baseline until 24 months
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
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
- •Poor deltoid function
- •Revision surgery
- •Suspected chronic infection
- •Acute fracture
Outcomes
Primary Outcomes
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.
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. The motion analysis includes measurement of translation along three orthogonal axes and rotations around two orthogonal axes. CTMA is a marker-free motion analysis, and the images are obtained on a standard CT-machine. Analysis and computation of motion data are performed using proprietary software at Sectra AB (collaborating partner) CTMA is a relative new method to measure implant migration. The precision of the measurements is 0.08-0.15 mm for translation and 0.23-0.54º for rotation, therefore, CTMA is capable of measuring very small movements of the implant relative to the surrounding bone.
Secondary Outcomes
- Change in WOOS Index(Before randomization, 3, 12 and 24 months postoperatively.)
- Change in Constant-Murley Score(Before randomization, 3, 12 and 24 months postoperatively.)
- Anchor Question 2(3, 12 and 24 months postoperatively)
- Change in range of motion(Before randomization, 3, 12 and 24 months postoperatively.)
- Anchor Question 1(Before randomization, 3, 12 and 24 months postoperatively.)
- Change in Subjective Shoulder Value(Before randomization, 3, 12 and 24 months postoperatively.)
- Change in EuroQol-5(Before randomization, 3, 12 and 24 months postoperatively.)