Anatomic Versus Reverse Shoulder Arthroplasty for Primary Glenohumeral Osteoarthritis

NCT06513559 | Withdrawn DMC FDA Device

• 1 other identifier: 159808
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Glenohumeral Osteoarthritis

Keywords

glenohumeral osteoarthritis; reverse total shoulder arthroplasty; anatomic replacement; reverse replacement; range of motion; pain

Outcome Measures

Primary Outcomes (4)

• American Shoulder and Elbow Surgeons score

  Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100.

  date of surgery

• American Shoulder and Elbow Surgeons score

  Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100.

  6 months after date of surgery

• American Shoulder and Elbow Surgeons score

  Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100.

  12 months after date of surgery

• American Shoulder and Elbow Surgeons score

  Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100.

  24 months after date of surgery

Study Arms (2)

Anatomic total shoulder replacement

EXPERIMENTAL

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

Device: Anatomic total shoulder replacement

Reverse total shoulder replacement

EXPERIMENTAL

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

Device: Reverse total shoulder replacement

Interventions

Anatomic total shoulder replacement DEVICE

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

Also known as: 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

Anatomic total shoulder replacement

Reverse total shoulder replacement DEVICE

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

Also known as: Arthrex Universe Reverse., Stryker perform reverse, Enovis Altivate reverse, Exactech Equinoxe reverse

Reverse total shoulder replacement

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary glenohumeral arthritis,
• Intact rotator cuff,

You may not qualify if:

• 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,

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Orthopedics

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher Joyce, M.D.

  University of Utah Orthopaedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 22, 2024
• Study Start: August 2, 2023
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: February 28, 2025

Record last verified: 2025-02

Locations

US (1)