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New shoulder implant tested for long-term relief in severe tears and arthritis

NCT ID NCT05868148

Disease control 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 1 time

Summary

This study follows 200 adults who receive the Shoulder iD™ implant to treat severe rotator cuff tears or shoulder arthritis. Researchers measure how well the shoulder works and how often the implant needs to be fixed or replaced over 10 years. Participants attend regular check-ups, have X-rays or CT scans, and fill out questionnaires about their shoulder function and pain.

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

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Dec 2035

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

The intended patient population are adult patients who have reached skeletal maturity, with a functional deltoid muscle, and massive and non-repairable rotator cuff tear within one or more indications and zero contraindications with pain disabled by: * Rheumatoid arthritis * Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) * Correction of functional deformity * Fractures of the humeral head * Traumatic arthritis * Revision of glenohumeral joint if sufficient native glenoid bone remains

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 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: * Patients who are 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 to as a "vulnerable subject" in section 3.44 of the ISO 14155:2020). * 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 (reassessed at time of surgery) * Significant injury to the brachial plexus * Inadequate bone stock in the proximal humerus or glenoid fossa for supporting the device components * Neuromuscular disease (e.g., joint neuropathy) Known allergy to one of the product materials * Metabolic disorders which may impair bone formation

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Conditions

The condition(s) this trial relates to.

avascular necrosis disease humerus fracture osteoarthritis rheumatoid arthritis Rotator Cuff Injuries rotator cuff syndrome

As listed by the trial registrant

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

Avascular necrosis of the head of humerus Fracture, humeral Osteoarthritis shoulder Rheumatoid arthritis shoulder Rotator cuff tears Shoulder deformity Traumatic arthritis of right shoulder region (diagnosis)

Contacts and locations

Locations

  • Carilion Clinic

    Roanoke, Virginia, 24014, United States

  • Jameson Crane Sports Medicine Institute OSU

    Columbus, Ohio, 43202, United States

  • UCSF

    San Francisco, California, 94158, United States

  • UT Health Science center - Houston

    Houston, Texas, 77030, United States

  • UT Southwestern

    Frisco, Texas, 75033, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.