Does BIO-RSA Provides Superior Clinical Outcome Compared to Conventional RSA?

NCT ID: NCT06025331

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-15
• Study Completion Date: 2033-08-01

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.

Conditions

Arthroplasty, Replacement, Shoulder; Shoulder Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BIO-RSA

Group Type: EXPERIMENTAL

BIO-RSA

Intervention Type: PROCEDURE

Bony increased offset-reversed shoulder arthroplasty(BIO-RSA) will be performed.

RSA

Group Type: ACTIVE_COMPARATOR

RSA

Intervention Type: PROCEDURE

Conventional reversed shoulder arthroplasty(RSA) will be performed.

Interventions

BIO-RSA

Bony increased offset-reversed shoulder arthroplasty(BIO-RSA) will be performed.

Intervention Type: PROCEDURE

RSA

Conventional reversed shoulder arthroplasty(RSA) will be performed.

Intervention Type: PROCEDURE

Other Intervention Names

Bony increased offset-reversed shoulder arthroplasty; Reverse shoulder arthroplasty

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haukeland University Hospital

OTHER

Sponsor Role: collaborator

Sykehuset Telemark

OTHER_GOV

Sponsor Role: collaborator

University Hospital, Akershus

OTHER

Sponsor Role: collaborator

Lovisenberg Diakonale Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sigbjørn Dimmen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oslo

Kjersti Kaul Jenssen, PhD

Role: PRINCIPAL_INVESTIGATOR

Lovisenberg Diaconal Hospital

Christian Owesen, PhD

Role: STUDY_DIRECTOR

Lovisenberg Diaconal Hospital

Locations

Sykehuset Telemark HF

Skien, Telemark, Norway

Site Status: NOT_YET_RECRUITING

Lovisenberg Diaconal Hospital

Oslo, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Kjersti Kaul Jenssen, PhD

Role: CONTACT

KjerstiKaul.Jenssen@lds.no

+4790200650

Hanne Fuglø, MPTh

Role: CONTACT

hanne.fuglo@lds.no

+4790524172

Facility Contacts

Birthe Marie Roang-Winjum, MD

Role: primary

birroa@sthf.no

+4790665939

Hanne Fuglø, MSc

Role: primary

hanne.fuglo@gmail.com

90524172

Other Identifiers

CARS-1

Identifier Type: -

Identifier Source: org_study_id