Recruiting

Humeral System

Sponsor:

Stryker Trauma and Extremities

Code:

NCT05067543

Conditions

Osteoarthritis Shoulder

Avascular Necrosis

Post-traumatic Arthrosis of Other Joints, Shoulder Region

Rotator Cuff Tear Arthropathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tornier Perform Humeral - Stem

Study Details

Brief summary:

This study is an international, single arm, multicenter, prospective, non-significant risk, Post-Market Clinical Follow-up study, which is designed to collect safety and performance data at baseline, surgery, immediate post-op and annually through 10 years post-operation.

Data collected from this study will be used for purposes, including but not limited to, Post-Market Surveillance, peer-reviewed publications, education materials, regulatory submissions, and/or product development.

Conditions

Osteoarthritis Shoulder

Avascular Necrosis

Post-traumatic Arthrosis of Other Joints, Shoulder Region

Rotator Cuff Tear Arthropathy

Study ID

NCT05067543

Start date

Sep 12, 2021

Status verified date

Aug, 2026

Completion date

Dec 1, 2037

Anticipated

Primary completion date

Jun 30, 2037

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18 years or older at the time of the informed consent or non-opposition (when applicable).
  • Informed and willing to sign an informed consent form approved by IRB or EC (when applicable).
  • Willing and able to comply with the requirements of the study protocol.
  • Considered a candidate for shoulder arthroplasty using a study device.
  • Meets indications for use requirements or other local, regional, or geographic specific regulatory requirements

Exclusion Criteria:

  • Not able to comply with the study procedures based on the judgment of the assessor (e.g. cannot comprehend study questions, inability to keep scheduled assessment times)
  • Patient belongs to a vulnerable group of patients, including minor patients, those unable to decide for themselves to participate or needing a Legally Authorized Representative (LAR), or others who could be subject to coercion (patients who may not be acting on their own initiative) (referred as "vulnerable subject" in the section 3.44 of the ISO 14155 norm).
  • Active local or systemic infection, sepsis, or osteomyelitis
  • Poor bone quality, where there could be considerable migration of the prothesis and/or a chance of fracture of the humerus or glenoid
  • Significant injury to the brachial plexus
  • Inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components
  • Neuromuscular disease (e.g., joint neuropathy)
  • Patient with known allergy to one of the product materials
  • Metabolic disorders which may impair bone formation
  • Patient pregnancy
  • Planned for two-stage surgery

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Tornier Perform Humeral System - Stem

Partial or total shoulder arthroplasty using the Tornier Perform Humeral Stem.

Interventions

Tornier Perform Humeral - Stem

The PERFORM Humeral System - Stem is a non-constrained prosthesis intended for the total or partial replacement of the glenohumeral articulation.

Primary outcome measure

  • Change from Baseline to last follow-up visit in ASES scores [ Time Frame: Baseline through Follow-Up visits through 24 months Post-Op ]

Central Contacts and Locations

Central contacts

Amjad Uneisi

33638213703amjad.uneisi@stryker.com

Caryn Thompson

704-891-6540caryn.thompson@stryker.com

Locations

Baptist Healthcare

Recruiting

Lexington, Kentucky, United States, 40503

Contacts

Johnetta Comello

johnetta.comello@bhsi.com

Principal Investigator:

Brent Morris

Summit Orthopedics

Recruiting

Eagan, Minnesota, United States, 55121

Contacts

Ned Tervola

ntervola@gmail.com

Principal Investigator:

Michael Freehill, MD

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Kate Agan

614-366-7598kate.agan@osumc.edu

Principal Investigator:

Julie Bishop, MD

Orthopedic Institute

Recruiting

Sioux Falls, South Dakota, United States, 57105

Contacts

Khris Loe

kloe@ortho-i.com

Principal Investigator:

Keith Baumgarten, MD

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84108

Contacts

Ashley Neese

Ashley.Neese@hsc.utah.edu

Principal Investigator:

Christopher Joyce

More Information

Sponsor

Stryker Trauma and Extremities

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Stryker Trauma and Extremities on 2026-09-01.