Anatomic Versus Reverse Shoulder Arthroplasty for Primary Glenohumeral Osteoarthritis

NCT ID: NCT06513559

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-02
• Study Completion Date: 2024-10-30

Brief Summary

The primary goal of the investigators prospective randomized study is to determine whether reverse total shoulder arthroplasty (RTSA) have at least as good results as anatomic TSA (non-inferiority), in patients with glenohumeral osteoarthritis, without rotator cuff tears nor significant glenoid retroversion.

The secondary goals are 1) to evaluate whether RTSA eventually grants superior postoperative clinical and radiographic outcomes than anatomic TSA (superiority), 2) to determine whether RTSA is associated with fewer postoperative complications than anatomic TSA.

The devices being used in the research are an Arthrex Universe system (Arthrex Univers Reverse vs Arthrex Apex humeral stem or Eclipse stem with a polyethylene glenoid). They are FDA approved, commonly used, and used as indicated. The anatomic replacement replaces the humeral head with a metal ball and the glenoid socket with a polyethylene glenoid component. The reverse shoulder replacement reverses these implants with the polyethylene socket on the humeral side and the glenosphere going on the glenoid side.

In all cases, a deltopectoral incision will be used as the procedure type.

Detailed Description

Total anatomic shoulder arthroplasty (TSA) is an effective treatment of severe glenohumeral osteoarthritis, with significant improvement in shoulder pain and function. Concerns about glenoid loosening, associated with difficult revision procedures and disappointing outcomes, have however been raised.

Reverse total shoulder arthroplasty (RTSA) was designed to treat cuff tear arthropathy. Favorable early reports led to the expansion of using RTSA to treat other shoulder fractures as well as osteoarthritis with poor glenoid bone stock. Recent reports revealed excellent clinical results of RTSA for primary glenohumeral arthropathy with intact rotator cuff and a low rate of complications.

Retrospective studies comparing functional results - of anatomic TSA for treating glenohumeral osteoarthritis with RTSA for rotator cuff arthropathy - found equivalent or greater improvements in American Shoulder and Elbow Surgeons score (ASES) at >2-year follow-up. In a study comparing anatomic TSA to RTSA for the treatment of glenohumeral osteoarthritis with intact rotator cuffs, investigators have reported equivalent functional results at >2-year follow-up. However, this study could not eliminate biases, such that RTSA patients had higher preoperative glenoid retroversion than anatomic TSA patients.The investigators therefore hypothesize that, in patients treated for glenohumeral osteoarthritis, RTSA will render better functional outcomes than anatomic TSA, at 2 postoperative years. Many other studies have confirmed this hypothesis. Moreover, several studies revealed good long-term survivorship after RTSA.

There are no published prospective studies that compared 2-year functional outcomes of RTSA and anatomic TSA for the treatment of primary glenohumeral osteoarthritis with intact rotator cuffs and no excessive glenoid retroversion.

Conditions

Glenohumeral Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Anatomic total shoulder replacement

Anatomic replacement replaces the humeral head with a metal ball and the glenoid socket with a polyethylene glenoid component.

Group Type: EXPERIMENTAL

Anatomic total shoulder replacement

Intervention Type: DEVICE

Humeral head with a metal ball and the glenoid socket with a polyethylene glenoid component.

Reverse total shoulder replacement

Reverse shoulder replacement reverses these implants with the polyethylene socket on the humeral side and the glenosphere going on the glenoid side.

Group Type: EXPERIMENTAL

Reverse total shoulder replacement

Intervention Type: DEVICE

Polyethylene socket on the humeral side and the glenosphere going on the glenoid side.

Interventions

Anatomic total shoulder replacement

Humeral head with a metal ball and the glenoid socket with a polyethylene glenoid component.

Intervention Type: DEVICE

Reverse total shoulder replacement

Polyethylene socket on the humeral side and the glenosphere going on the glenoid side.

Intervention Type: DEVICE

Other Intervention Names

Arthrex Eclipse stem with a polyethylene glenoid.; Stryker perform stem with cortiloc glenoid; Enovis CS Edge stem with altivate anatomic glenoid; Exactech Equinoxe stem with cage anatomic glenoid; Arthrex Universe Reverse.; Stryker perform reverse; Enovis Altivate reverse; Exactech Equinoxe reverse

Eligibility Criteria

Inclusion Criteria

• Primary glenohumeral arthritis,
• Intact rotator cuff,

Exclusion Criteria

• Patients between 60 and 85 years old (based on indications for RTSA)
• Informed Consent as documented by signature (Appendix Informed Consent Form).

• B2 glenoid with > 80% posterior humeral head subluxation or greater 25 degrees neoglenoid retroversion,
• B3 and C type glenoids,
• Full thickness rotator cuff tear,
• Acute or malunited proximal humeral fracture,
• Chronic locked dislocation
• Rheumatoid arthritis,
• Revision surgery or surgical antecedents,
• Tumors,
• Axillary nerve damage,
• Non-functioning deltoid muscle,
• Glenoid vault deficiency precluding baseplate fixation,
• Infection and neuropathic joints,
• Known or suspected non-compliance, drug or alcohol abuse,
• Patients incapable of judgement or under tutelage,
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, contraindication for CT scan etc. of the participant,

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Christopher Joyce

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher Joyce, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Utah Orthopaedics

Locations

University of Utah Orthopedics

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

159808

Identifier Type: -

Identifier Source: org_study_id