New shoulder implant shows promise for arthritis patients
NCT ID NCT02405208
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
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156 people
The number who actually took part.
- Started
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Aug 2010
- Finished
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Sep 2023
- Lead sponsor
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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
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21 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Barwon Health
Geelong, Victoria, 3220, Australia
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Brisbane Hand & Upper Limb Clinic
Brisbane, Queensland, 4001, Australia
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Danderyd Hospital
Stockholm, S-182 88, Sweden
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Institut Nices
Nice, 06000, France
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Wrightington Hospital
Wigan, Wrightington, WN6 9EP, United Kingdom
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Other studies related to the condition(s) this trial covers.
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