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Shoulder fracture device under Long-Term watch

NCT ID NCT05773352

Knowledge-focused Sponsor: Stryker Trauma and Extremities Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 2 times

Summary

This study follows 118 adults who received a shoulder replacement using the Tornier Perform® Humeral System after a fracture or related joint damage. Researchers will collect data on pain, function, and safety over 10 years. The goal is to monitor real-world performance, not to test a new treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

118 people

The number who actually took part.

Started

Aug 2023

Expected to finish

Sep 2034

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Approximately 120 subjects are to be enrolled in this clinical investigation. Subjects participating in this clinical investigation will be recruited from the investigator's standard subject population, where all subjects presenting for an anatomic or reverse shoulder arthroplasty will be evaluated for clinical investigation participation based on the eligibility criteria.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 18 years or older at the time of the informed consent or the non-opposition (when applicable) * Informed and willing to sign an informed consent form (ICF) 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 with the device for shoulder joint disabled by: * Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint, including humeral head fracture and displaced 3-or 4-part proximal humeral fractures * Fracture sequelae * Revisions where adequate fixation can be achieved, and adequate bone stock remains after final reconstruction * Proximal humerus bone defect (reverse configuration) 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 subjects, including minor subjects, those unable to decide for themselves to participate or needing a LAR, or others who could be subject to coercion (subjects who may not be acting on their own initiative) (referred as "vulnerable subject" in the section 3.44 of the ISO 14155:2011 norm) * Any absolute contraindications as mentioned in the device Instruction For Use (available on ifu.stryker.com)

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Conditions

The condition(s) this trial relates to.

humerus fracture

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fracture humerus Revision of other devices if sufficient bone stock remains Traumatic arthritis Traumatic arthropathy of shoulder

Contacts and locations

Locations

  • California Pacific Orthopaedics

    San Francisco, California, 94118, United States

  • Eisenhower Health Desert Orthopedic Center

    Rancho Mirage, California, 92270, United States

  • Loyola University Chicago

    Maywood, Illinois, 60153, United States

  • More Foundation

    Phoenix, Arizona, 85023, United States

  • Tennessee Orthopaedic Alliance

    Columbia, Tennessee, 38401, United States

  • The Center for Bone and Joint Disease

    Hudson, Florida, 34667, United States

  • University of Arkansas Medical Sciences

    Little Rock, Arkansas, 72205, United States

  • University of Texas/UT Health

    Houston, Texas, 77030, United States

  • Washington University

    St Louis, Missouri, 63110, United States

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