Perform Humeral System Study

NCT05067543 | Recruiting FDA Device

• 1 other identifier: 20D-W-PHS-RM
• Study Type: observational
• Target: 300
• Locations: 5 countries
• Sites: 10

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

Outcome Measures

Primary Outcomes (1)

• Change from Baseline to last follow-up visit in ASES scores

  ASES Score = American Shoulder and Elbow Surgeons Score, 11 items with total score reported out of 100 measuring pain and activity of patient's evaluated shoulder where lower scores indicate more pain and less function

  Baseline through Follow-Up visits through 24 months Post-Op

Secondary Outcomes (7)

• Change from Baseline to last follow-up visit in Constant Murley scores

  Baseline through Follow-Up visits through 10 years Post-Op

• Change from Baseline to last follow-up visit in SANE scores

  Baseline through Follow-Up visits through 10 years Post-Op

• Change from Baseline to last follow-up visit in Subject Satisfaction scores

  Baseline through Follow-Up visits through 10 years Post-Op

• Change from Baseline to last follow-up visit in EQ-5D scores

  Baseline through Follow-Up visits through 10 years Post-Op

• Number of device associated and procedure associated adverse events.

  Baseline through Follow-Up visits through 10 years Post-Op

Study Arms (1)

Tornier Perform Humeral System - Stem

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

Device: Tornier Perform Humeral - Stem

Interventions

Tornier Perform Humeral - Stem DEVICE

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

Tornier Perform Humeral System - Stem

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients intended for the total or partial replacement of the glenohumeral articulation.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stryker Trauma and Extremities: lead

Study Sites (10)

Baptist Healthcare

Lexington, Kentucky, 40503, United States

RECRUITING

Summit Orthopedics

Eagan, Minnesota, 55121, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

TERMINATED

Washington University

St Louis, Missouri, 63110, United States

ACTIVE NOT RECRUITING

Orthopedic Institute

Sioux Falls, South Dakota, 57105, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84108, United States

RECRUITING

Roth McFarlane Hand and Upper Limb Centre

London, Ontario, N6A 4L6, Canada

ACTIVE NOT RECRUITING

Orthopedic Center Santy

Lyon, 69008, France

ACTIVE NOT RECRUITING

Schulthess Klinik

Zurich, CH-8008, Switzerland

ACTIVE NOT RECRUITING

Wrightington Hospital

Wigan, Lancashire, WN6 9EP, United Kingdom

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Osteonecrosis; Rotator Cuff Tear Arthropathy

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Chondrocalcinosis; Arthritis; Joint Diseases; Crystal Arthropathies

Study Officials

• Rebecca Gibson

  Stryker Trauma

  STUDY DIRECTOR

Central Study Contacts

Meredith Schreier

CONTACT

901-232-2704; meredith.schreier@stryker.com

Amjad Uneisi

CONTACT

amjad.uneisi@stryker.com

Study Design

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

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 5, 2021
• Study Start: September 12, 2021
• Primary Completion (Estimated): June 30, 2036
• Study Completion (Estimated): December 1, 2036
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (6); GB (1); FR (1); CH (1); CA (1)