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Tornier Perform Humeral System for Shoulder Conditions

This study is observing how well the Tornier Perform Humeral System works for people with shoulder problems like osteoarthritis or rotator cuff tears. This system is a non-constrained prosthesis, meaning it's an artificial joint replacement that allows for more natural movement. Researchers are looking at how your pain, function, and quality of life change over time after surgery with this device. They will also check the safety of the implant. You could be eligible if you are 18 or older, need shoulder replacement surgery, and are willing to follow the study plan. The study aims to show the safety and performance of the device.

Study design
This is an international, multi-center observational study, meaning researchers will collect information from about 300 participants who receive the Tornier Perform Humeral System.
What's involved
You would have follow-up visits at baseline, immediately after surgery, and then annually for up to 10 years after your operation.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 10 years after their surgery to assess the safety and performance of the device.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05067543

Perform Humeral System Study

Recruiting
Not specifiedAges 18+Observational
Stryker Trauma and Extremities
~300 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:Tornier Perform Humeral - Stem

At a glance

Recruiting sites
5 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline to last follow-up visit in ASES scores
Measured over Baseline through Follow-Up visits through 24 months Post-Op

Conditions

Osteoarthritis Shoulder
Avascular Necrosis
Post-traumatic Arthrosis of Other Joints, Shoulder Region
Rotator Cuff Tear Arthropathy

Explore related trials

Avascular NecrosisOsteoarthritisPost-traumatic kyphosisRotator cuff tear arthropathy

Where it's being run

11 sites across 10 states
Minnesota2
Kentucky1
Missouri1
Ohio1
South Dakota1
Utah1
Ontario1
France1

Study leadership

  • Rebecca Gibson · STUDY_DIRECTOR · Stryker Trauma

Who to contact

Meredith Schreier
[email protected]
901-232-2704
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change from Baseline to last follow-up visit in ASES scoresBaseline through Follow-Up visits through 24 months Post-Op

    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