Shoulder Arthroplasty for Shoulder Osteoarthritis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Rheumatoid arthritis, Tumors, Alcohol abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Surgery and immediate recovery

Trial Summary

What is the purpose of this trial?

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.

Research Team

Christopher Joyce, M.D.

Principal Investigator

University of Utah Orthopaedics

Eligibility Criteria

This trial is for individuals with glenohumeral osteoarthritis, which affects the shoulder joint. Participants should not have rotator cuff tears or significant backward tilting of the socket part of their shoulder joint. The study is looking for people who can undergo surgery using a specific incision technique.

Inclusion Criteria

I am between 60 and 85 years old.

My shoulder bone is intact without significant loss.

Informed Consent as documented by signature (Appendix Informed Consent Form)

Exclusion Criteria

I have a tumor.

Known or suspected non-compliance, drug or alcohol abuse

I have damage to the nerve in my armpit area.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either anatomic or reverse total shoulder arthroplasty

Surgery and immediate recovery

1 visit (in-person for surgery)

Follow-up

Participants are monitored for functional outcomes and complications

24 months

Regular follow-up visits

Treatment Details

Interventions

• Anatomic total shoulder replacement
• Reverse total shoulder replacement

Trial Overview The study compares two types of shoulder replacement surgeries: reverse total shoulder arthroplasty (RTSA) and anatomic total shoulder arthroplasty (TSA). It aims to see if RTSA is at least as effective as TSA or even better, and whether it leads to fewer complications post-surgery.

Participant Groups

Group I: Reverse total shoulder replacement Experimental Treatment 1 Intervention

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

Group II: Anatomic total shoulder replacement Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+