NCT06153940 Everglade Stem, World Cup and World Liner Post Market Clinical Follow-up
| NCT ID | NCT06153940 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Signature Orthopaedics |
| Condition | Hip Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-11-22 |
| Primary Completion | 2028-03-01 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The aim of the Study is to monitor the performance of the Signature Orthopaedics Everglade Stem, World Acetabular Cup and World Liner as a part of post-market vigilance and continuous improvement efforts.
Eligibility Criteria
Inclusion Criteria: * patient requires unilateral primary total hip arthroplasty due to non-inflammatory degenerative joint disease (e.g. osteoarthritis, traumatic arthritis, avascular necrosis, dysplasia/DDH) * patient must be a candidate for use of the products studied, as determined jointly by the surgeon and patient * male and non-pregnant female patients aged 18-75 * patients who understand the conditions of the clinical evaluation and are willing to participate for the length of the prescribed follow-up Exclusion Criteria: * patient has active infection or sepsis(treated or untreated) enough to compromise implant stability or postoperative recovery * patient is a female of child-bearing age and not taking and not taking contraceptive pills * patient has inadequate bone stock to support the device (e.g. severe osteopenia, family history of severe osteoporosis or osteopenia) * patient has a known or suspected metal sensitivity * patient is immuno-suppressed with disease such as AID