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New shoulder implant shows promise for arthritis patients

NCT ID NCT02405208

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested a new shoulder implant called PyroTITAN HRA in 156 people with arthritis. The implant resurfaces the ball part of the shoulder joint to relieve pain and improve function. Researchers tracked how long the device lasted and whether it caused problems, aiming to see if it's a good option for shoulder arthritis.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PyroTITAN HRA shoulder implant (a device that resurfaces the humeral head of the shoulder joint)
What this could lead to
If successful, this implant could provide a durable option for shoulder arthritis patients, potentially delaying or avoiding the need for a full shoulder replacement.
What could go wrong
This is a completed study with 156 participants, but it was not randomized or blinded, so results may be less reliable. The implant may fail over time, requiring additional surgery.

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

156 people

The number who actually took part.

Started

Aug 2010

Finished

Sep 2023

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

Subjects who require humeral head resurfacing arthroplasty.

Ages

21 to 75 years

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: 1. Patients selected for inclusion will present for primary shoulder surface replacement or arthroplasty with any of the following diagnoses: * Osteoarthritis * Rheumatoid / Inflammatory Arthritis * Post-traumatic arthritis. * Focal and large (Hill-Sachs) osteochondral defects. 2. Subject is able to or capable of providing consent to participate in the clinical investigation. 3. Subject agrees to comply with this protocol, including participating in required follow-up visits at the investigations site and completing study questionnaires. 4. Subject is at least 21 years of age and skeletally mature at the time of surgery. Exclusion Criteria: 1. Have destruction of the proximal humerus to preclude rigid fixation of the humeral component. 2. Insufficient bone quality as determined by intra-operative evaluation. 3. Have arthritis with defective rotator cuff. 4. Have had a failed rotator cuff surgery. 5. Have loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified. 6. Have evidence of active infection. 7. Present with a condition of neuromuscular compromise of the shoulder (e.g., neuropathic joints or brachioplexis injury with a flail shoulder joint). 8. Are unwilling or unable to comply with a rehabilitation program or would fail to return for the postoperative follow-up visits prescribed by the protocol. 9. Are skeletally immature. 10. Have a known allergic reaction to pyrocarbon. 11. Have other conditions such as central nervous system disturbances, alcohol or drug addiction, etc. that may make effective evaluation of the joint replacement difficult or impossible. 12. Are currently participating in another clinical study. 13. Have known, active metastatic or neoplastic disease. 14. Are taking \> 10mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery. 15. Are under 21 years of age or over 75. . 16. Require glenoid replacement (Glenoid Classification).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Barwon Health

    Geelong, Victoria, 3220, Australia

  • Brisbane Hand & Upper Limb Clinic

    Brisbane, Queensland, 4001, Australia

  • Danderyd Hospital

    Stockholm, S-182 88, Sweden

  • Institut Nices

    Nice, 06000, France

  • Wrightington Hospital

    Wigan, Wrightington, WN6 9EP, United Kingdom

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