Under construction – not a live service
Sign in
Taking peopleNo phase

Perform Humeral System Study

Key facts

Who runs it
Stryker Trauma and Extremities
Where
Lyon, FranceSee the siteAlso in 4 other countries, 10 sites
Trial code
Status
Recruiting
People taking part
300 people, planned
Started
12 Sept 2021
Expected to end
1 Dec 2037
Type of study
Observational
Treatments tested
  • Tornier Perform Humeral - Stem
Record updated
1 September 2026

Who can take part

Age
18 years and older
Sex
Women and men

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Planned for two-stage surgery
  • Active local or systemic infection, sepsis, or osteomyelitis
  • Neuromuscular disease (e.g., joint neuropathy)
  • Patient with known allergy to one of the product materials
  • Metabolic disorders which may impair bone formation
  • 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)
  • 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
  • Patient pregnancy

Where in France

Also in 4 other countries, 10 sites

  • Orthopedic Center SantyLyon, FranceContact: Amjad UneisiNo longer taking part

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The group in the trial

  • Tornier Perform Humeral System - Stem

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

    Treatment: Tornier Perform Humeral - Stem

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
1 September 2026