Perform Humeral System Study (PHS)

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.

Study Overview

• Status: Recruiting
• Conditions: Avascular Necrosis; Osteoarthritis Shoulder; Rotator Cuff Tear Arthropathy; Post-traumatic Arthrosis of Other Joints, Shoulder Region
• Intervention / Treatment: Device: Tornier Perform Humeral - Stem

Detailed Description

This study is an international, single arm, multicenter, prospective, non-significant risk, Post-Market Clinical Follow-up study. Data will be collected for the commercially available PERFORM™ Humeral System. The objective of this study is to demonstrate the safety and performance of the PERFORM™ Humeral System devices after implantation over a standard follow-up period using Patient Reported Outcome Measures related to quality of life, pain and functional improvements, safety of the implants, as well as radiographic assessments. Safety and performance measures will be evaluated throughout the patient's participation in the study.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Meredith Schreier; Phone Number: 901-232-2704; Email: meredith.schreier@stryker.com
• Study Contact Backup: Name: Amjad Uneisi; Email: amjad.uneisi@stryker.com

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 4L6
      • Active, not recruiting
      • Roth McFarlane Hand and Upper Limb Centre
• France
  • Lyon, France, 69008
    • Active, not recruiting
    • Orthopedic Center Santy
• Switzerland
  • Zurich, Switzerland, CH-8008
    • Active, not recruiting
    • Schulthess Klinik
• United Kingdom
  • Lancashire
    • Wigan, Lancashire, United Kingdom, WN6 9EP
      • Active, not recruiting
      • Wrightington Hospital
• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Recruiting
      • Baptist Healthcare
      • Principal Investigator: Brent Morris
      • Contact: Johnetta Comello; Email: johnetta.comello@bhsi.com
  • Minnesota
    • Eagan, Minnesota, United States, 55121
      • Recruiting
      • Summit Orthopedics
      • Principal Investigator: Michael Freehill, MD
      • Contact: Ned Tervola; Email: ntervola@gmail.com
    • Rochester, Minnesota, United States, 55905
      • Terminated
      • Mayo Clinic
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Active, not recruiting
      • Washington University
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Recruiting
      • Orthopedic Institute
      • Contact: Khris Loe; Email: kloe@ortho-i.com
      • Principal Investigator: Keith Baumgarten, MD
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • Recruiting
      • University of Utah
      • Contact: Ashley Neese; Email: Ashley.Neese@hsc.utah.edu
      • Sub-Investigator: Robert Tashjian
      • Principal Investigator: Christopher Joyce

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tornier Perform Humeral System - Stem; Partial or total shoulder arthroplasty using the Tornier Perform Humeral Stem.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline to last follow-up visit in Constant Murley scores	Combination of physician-completed and patient-reported portions to assess functional state of shoulder including range of motion; total score reported out of 100 measuring where lower scores indicate less function of the evaluated shoulder	Baseline through Follow-Up visits through 10 years Post-Op
Change from Baseline to last follow-up visit in SANE scores	SANE = Single Assessment Numeric Evaluation; 1 item assessment of shoulder rating 0% to 100%	Baseline through Follow-Up visits through 10 years Post-Op
Change from Baseline to last follow-up visit in Subject Satisfaction scores	Single, subjective question measuring patient satisfaction; assessed by improved, worsened, or no change in satisfaction	Baseline through Follow-Up visits through 10 years Post-Op
Change from Baseline to last follow-up visit in EQ-5D scores	The EuroQol Five Dimensions Questionnaire (EQ-5D) questionnaire is a standardized instrument for use as a measure of quality of life. It is cognitively simple, takes only a few minutes to complete, and provides a simple descriptive profile as well as a single index value for quality of life that can be used in the clinical and economic evaluation of health care. The EQ-5D consists of a descriptive system which comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression), and a visual analog scale which measures the respondent's self-rated health on a 0-100 scale.	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
Rates of revision surgeries.		Baseline through Follow-Up visits through 10 years Post-Op
Evaluation of radiological imaging of the affected shoulder	Images will be analyzed for bone characteristics (baseline and post-op) and device migration, component breakage, and radiolucency (post-op visits only).	Baseline through Follow-Up visits through 10 years Post-Op

Collaborators and Investigators

• Sponsor: Stryker Trauma and Extremities
• Investigators: Study Director: Rebecca Gibson, Stryker Trauma

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2021
• Primary Completion (Estimated): June 30, 2036
• Study Completion (Estimated): December 1, 2036

Study Registration Dates

• First Submitted: September 23, 2021
• First Submitted That Met QC Criteria: October 4, 2021
• First Posted (Actual): October 5, 2021

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Crystal Arthropathies; Bone Diseases; Musculoskeletal Diseases; Pathologic Processes; Arthritis; Joint Diseases; Necrosis; Chondrocalcinosis; Pathological Conditions, Signs and Symptoms; Rotator Cuff Tear Arthropathy; Osteonecrosis
• Other Study ID Numbers: 20D-W-PHS-RM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes