A Multi-center Outcomes Clinical Study of the PyroTITAN™ HRA Shoulder Implant in Humeral Head Resurfacing
NCT ID: NCT02405208
Last Updated: 2025-12-24
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
156 participants
OBSERVATIONAL
2010-08-31
2023-09-30
Brief Summary
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Detailed Description
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The investigation will be conducted by up to 10 International surgeons experienced in HRA. 387 subjects with PyroTITAN™ HRA Shoulder prosthesis arthroplasties will be implanted and followed for 10 years.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Primary cohort
Primary cohort will receive the PyroTITAN HRA device
PyroTITAN HRA
Humeral resurfacing using the PyroTITAN HRA device
Interventions
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PyroTITAN HRA
Humeral resurfacing using the PyroTITAN HRA device
Eligibility Criteria
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Inclusion Criteria
* 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
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).
21 Years
75 Years
ALL
No
Sponsors
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Smith & Nephew, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Julie Lankiewicz
Role: STUDY_DIRECTOR
Smith & Nephew, Inc.
Locations
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Brisbane Hand & Upper Limb Clinic
Brisbane, Queensland, Australia
Barwon Health
Geelong, Victoria, Australia
Institut Nices
Nice, , France
Danderyd Hospital
Stockholm, , Sweden
Wrightington Hospital
Wigan, Wrightington, United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CP-HRA-002
Identifier Type: -
Identifier Source: org_study_id