Clinical trial NCT06025448: Is MIO-RSA Noninferior to BIO-RSA When it Comes to Mechanical Implant Stability?
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)?).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arthroplasty Complications
Shoulder Osteoarthritis
Keywords: Reverse shoulder arthroplasty
BIO-RSA
MIO-RSA
Bony lateralization
Metallic lateralization
Orthopedic Surgery
Lead sponsor: Lovisenberg Diakonale Hospital
Sponsor class: OTHER
First posted: 2023-09-06
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Migration of glenoid component from baseline until 24 months
timeFrame: At baseline and 3, 6, 12 and 24 months postoperatively. 24 months will be the primary outcome.
Secondary outcomes:
measure: Change in WOOS Index
timeFrame: Before randomization, 3, 12 and 24 months postoperatively.
measure: Change in Constant-Murley Score
timeFrame: Before randomization, 3, 12 and 24 months postoperatively.
measure: Change in EuroQol-5
timeFrame: Before randomization, 3, 12 and 24 months postoperatively.
measure: Change in range of motion
timeFrame: Before randomization, 3, 12 and 24 months postoperatively.
measure: Change in Subjective Shoulder Value
timeFrame: Before randomization, 3, 12 and 24 months postoperatively.
measure: Anchor Question 1
timeFrame: Before randomization, 3, 12 and 24 months postoperatively.
measure: Anchor Question 2
timeFrame: 3, 12 and 24 months postoperatively
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Lovisenberg Diaconal Hospital
Study officials:
affiliation: University of Oslo
name: Sigbjørn Dimmen, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Lovisenberg Diaconal Hospital
name: Kjersti Kaul Jenssen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lovisenberg Diaconal Hospital
name: Christian Owesen, PhD
role: STUDY_DIRECTOR
References: