Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2025-12-24 @ 3:29 PM
NCT ID:
NCT02983292
Eligibility Criteria:
Inclusion Criteria:
Patients of either sex will be included, if they:
1. Present (prospective cohort) or presented (retrospective cohort) for primary shoulder surface replacement or arthroplasty with any of the following diagnoses:
1. Osteoarthritis
2. Rheumatoid / Inflammatory Arthritis
3. Post-traumatic arthritis.
4. Focal and large (Hill-Sachs) osteochondral defects.
2. Subject receives (prospective cohort) the PyroTITAN HRA device after the re-release of the product or received (retrospective cohort) the PyroTITAN HRA device after the re- release of the product and is enrolled in the study prior to their two-year follow-up visit.
3. Subject is able to or capable of providing consent to participate in the clinical investigation.
4. Subject agrees to comply with this protocol, including participating in required follow-up visits at the investigations site and completing study questionnaires.
5. Subject is at least 18 years of age and skeletally mature at the time of surgery.
Exclusion Criteria:
Patients will be excluded from participation if they:
1. Has/had destruction of the proximal humerus to preclude rigid fixation of the humeral component.
2. Has/had insufficient bone quality as determined by intra- operative evaluation.
3. Has/had arthritis with defective rotator cuff.
4. Has/had had a failed rotator cuff surgery.
5. Has/had loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.
6. Has/had evidence of active infection.
7. Present/presented with a condition of neuromuscular compromise of the shoulder (e.g., neuropathic joints or brachioplexus 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/were skeletally immature.
10. Has/had a known allergic reaction to PyroCarbon.
11. Has/had 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. Has/had known, active metastatic or neoplastic disease.
13. Are/were taking \> 10mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery.
14. Are/were under 21 years of age or over 75.
15. Require/required glenoid replacement.
16. Retrospective patients cannot be enrolled if they are two year or greater out from the index surgery.
17. Women, who are pregnant or are planning to become pregnant.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02983292
Study Brief:
Protocol Section:
NCT02983292