Clinical trial NCT06025331: Does BIO-RSA Provides Superior Clinical Outcome Compared to Conventional RSA?
Official title: From Cuff Arthropathy to Reverse Shoulder Arthroplasty - a Multicentre Randomized Control Trial (Study 1: Does BIO-RSA Provides Superior Clinical Outcome Compared to Conventional RSA?).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arthroplasty, Replacement, Shoulder
Shoulder Osteoarthritis
Keywords: Reverse Shoulder Arthroplasty
BIO-RSA
Orthopedic surgery
Lead sponsor: Lovisenberg Diakonale Hospital
Sponsor class: OTHER
Collaborators: name: Haukeland University Hospital
name: Sykehuset Telemark
name: University Hospital, Akershus
First posted: 2023-09-06
Enrollment: 130
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: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in WOOS index from baseline to 24 months postoperatively.
timeFrame: Before randomization, 24 months postoperatively. Also measured 3 and 12 months postoperatively. Change after 24 months will be the primary outcome.
Secondary outcomes:
measure: Change in EuroQol-5 from baseline to 24 months postoperatively.
timeFrame: Before randomization, 3, 12 and 24 months postoperatively.
measure: CT scan
timeFrame: Before randomization, 3, 12 and 24 months postoperatively.
measure: Change in Constant-Murley Score from baseline to 24 months postoperatively.
timeFrame: Before randomization, 3, 12 and 24 months postoperatively.
measure: Change in range of motion from baseline to 24 months postoperatively.
timeFrame: Before randomization, 3, 12 and 24 months postoperatively.
measure: Change in Subjective Shoulder Value from baseline to 24 months postoperatively.
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: Skien
country: Norway
facility: Sykehuset Telemark HF
state: Telemark
city: Oslo
country: Norway
facility: Lovisenberg Diaconal Hospital
Study officials:
affiliation: University of Oslo
name: Sigbjørn Dimmen, PhD
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: