OsseoFit Stemless Shoulder System (Anatomic)

NCT07421245 | Not Yet Recruiting FDA Device

• 1 other identifier: CMU2024-23E
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical research protocol is to evaluate the safety, efficacy, and long-term outcomes of the OsseoFit Stemless Shoulder System (Anatomic) in patients with a primary diagnosis of osteoarthritis. The study aims to assess the intraoperative characteristics, postoperative complications, functional outcomes, and radiographic findings associated with the use of the stemless implant system. Ultimately, this research aims to improve patient outcomes, enhance surgical techniques, and inform clinical decision-making in the treatment of shoulder pathology.

Conditions

Shoulder Injuries; Shoulder Pain; Shoulder Fractures; Shoulder Arthritis; Shoulder Disease

Outcome Measures

Primary Outcomes (1)

• the American Shoulder and Elbow Surgeons (ASES) Shoulder Score

  The primary endpoint is the American Shoulder and Elbow Surgeons (ASES) Shoulder Score. Improvement from baseline to 2 years will be evaluated using the overall mean change, with effectiveness demonstrated if the mean improvement exceeds the MCID of 10.8 points. The primary endpoint analysis will use the ITT population with all available data and no imputation. Hypotheses: H0: μCFB ≤ 10.8; H1: μCFB \> 10.8, where μCFB is the mean ASES change (2 years minus baseline). The MCID of 10.8 was established using the 0.5 SD distribution method based on psychometric evaluation of ASES scores from 3,667 shoulder arthroplasty patients with ≥2-year follow-up.

  2 years

Secondary Outcomes (12)

• Implant Survival

  10 Years

• ASES

  6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year

• Constant Murley

  6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year

• EQ-5D-5L composite

  6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year

• SANE

  6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year

Study Arms (2)

OsseoFit Stemless Inlay

Subjects who were implanted with the Inlay variant of the Osseofit Stemless Shoulder System.

Device: OsseoFit Stemless Inlay

OsseoFit Stemless Onlay

Subjects who were implanted with the Onlay variant of the Osseofit Stemless Shoulder System.

Device: OsseoFit Stemless Onlay

Interventions

OsseoFit Stemless Inlay DEVICE

Inlay implants have a dished superior portion with a shorter fin length to allow the implant to sit within the bone.

OsseoFit Stemless Inlay

OsseoFit Stemless Onlay DEVICE

The Onlay implants sit on top of the prepared bone.

OsseoFit Stemless Onlay

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The OsseoFit Stemless Shoulder implants are intended for shoulder joint arthroplasty. OsseoFit™ Stemless Shoulder humeral components have a porous surface and are indicated for uncemented biological fixation applications. Compatible Glenoid components are intended to be implanted with bone cement. The porous posts may be inserted without bone cement. Compatible Comprehensive Convertible Glenoid components are intended for cementless applications with the addition of screw fixation.

You may qualify if:

• Patient must be 20 years of age or older.
• The patient must be anatomically and structurally suited, as evident by scapula and proximal humerus closure, to receive the implants.
• Patient planned to receive OsseoFit™ anchor with uncemented fixation.
• Patient planned to receive a Modular Alliance Glenoid with bone cement. The porous posts must be coated with Porous Plasma Spray (PPS) and may be inserted without bone cement.
• Patient planned to receive shoulder arthroplasty due to osteoarthritis.
• Patient must be able and willing to complete the protocol required follow-up schedule.
• Patient must be able and willing to sign the IRB approved consent.

You may not qualify if:

• Patient is unwilling or unable to give consent or to comply with the follow-up program.
• Patient has any condition which would in the judgement of the Investigator, place the patient at undue risk or interfere with the study.
• Patient is known to be pregnant or breastfeeding.
• Patient is a vulnerable participant (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, and/or anticipated to be non-compliant).
• Patient is uncooperative or patient with neurologic disorders who is incapable or unwilling to follow directions.
• Patient has any neuromuscular disease compromising the affected limb.
• Patient has any sign of infection affecting the shoulder joint or in its proximity which may spread to the implant site. This may include:
• Local/systemic infection
• Sepsis
• Osteomyelitis
• Patient presents with Osteomalacia.
• Patient presents with a humeral bone fracture.
• Patient presents with malunion or non-union of the tuberosities of the proximal humerus.
• Patient has had a previous operative shoulder prosthesis (stem or stemless).
• Patient has irreparable cuff tear.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

The Research Foundation for the State University of New York

Buffalo, New York, 14228, United States

Location

MeSH Terms

Conditions

Shoulder Injuries; Shoulder Pain; Shoulder Fractures

Condition Hierarchy (Ancestors)

Wounds and Injuries; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fractures, Bone

Study Officials

• Jim Nevelos

  Zimmer Biomet

  STUDY DIRECTOR

Central Study Contacts

Octavia Gladden

CONTACT

(704) 493-0178; octavia.gladden@zimmerbiomet.com

Ryan Boylan

CONTACT

Ryan.Boylan@zimmerbiomet.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: February 19, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 1, 2036
• Study Completion (Estimated): January 1, 2036
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)