Clinical Trial Finder

Perform Humeral System Study

Study Purpose

The purpose of this study is to collect data needed to satisfy the European Union (EU) Medical Device Regulation (MDR) clinical post-market surveillance (PMS) and reporting requirements, and to support future regulatory submissions and peer-reviewed publications on device performance and safety.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05067543
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Stryker Trauma GmbH
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Rebecca Gibson
Principal Investigator Affiliation Stryker Trauma
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Enrolling by invitation
Countries Canada, France, Switzerland, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Osteoarthritis Shoulder, Avascular Necrosis, Post-traumatic Arthrosis of Other Joints, Shoulder Region
Arms & Interventions

Arms

: Tornier Perform Humeral System - Stem

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

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic, Rochester, Minnesota

Status

Address

Mayo Clinic

Rochester, Minnesota, 55905

Washington University, Saint Louis, Missouri

Status

Address

Washington University

Saint Louis, Missouri, 63110

Orthopedic Institute, Sioux Falls, South Dakota

Status

Address

Orthopedic Institute

Sioux Falls, South Dakota, 57105

University of Utah, Salt Lake City, Utah

Status

Address

University of Utah

Salt Lake City, Utah, 84108

International Sites

London, Ontario, Canada

Status

Address

Roth McFarlane Hand and Upper Limb Centre

London, Ontario, N6A 4L6

Orthopedic Center Santy, Lyon, France

Status

Address

Orthopedic Center Santy

Lyon, ,

Schulthess Klinik, Zürich, Switzerland

Status

Address

Schulthess Klinik

Zürich, ,

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