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Follow-up of a shoulder replacement stem in people with shoulder joint damage

Follows safety and performance of the Tornier Perform Humeral Stem in shoulder surgery patients.

Key facts

Who runs it
Stryker Trauma and Extremities
Where
Zurich, SwitzerlandSee the siteAlso in 4 other countries, 10 sites
Trial code
Registry title
Perform Humeral System Study
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

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who are planned to have a partial or total shoulder replacement with the Tornier Perform Humeral Stem. Conditions include shoulder osteoarthritis, avascular necrosis, arthrosis after injury and rotator cuff tear arthropathy.

Age
18 years or older
Sex
All sexes
Disease stage
People who are candidates for shoulder replacement surgery with the study device and meet its indications for use.

Main reasons for not taking part

  • Active local or whole-body infection, sepsis, or bone infection (osteomyelitis)
  • Poor bone quality or not enough bone in the upper arm or shoulder socket to support the implant
  • Significant injury to the brachial plexus (nerves of the shoulder), or neuromuscular disease
  • Known allergy to a product material, or metabolic disorders that may harm bone formation
  • Pregnancy, vulnerable patients, or a planned two-stage surgery

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 Switzerland

Also in 4 other countries, 10 sites

  • Schulthess KlinikZurich, SwitzerlandContact: 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.
Official title
Perform Humeral System Study
Plain-language title
Follow-up of a shoulder replacement stem in people with shoulder joint damageGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
1 September 2026