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Recruiting NCT06172569

Spartan Stem, World Cup and World Liner Post Market Clinical Follow-up Study

Trial Parameters

Condition Hip Replacement
Sponsor Signature Orthopaedics
Study Type OBSERVATIONAL
Phase N/A
Enrollment 200
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2023-12-08
Completion 2028-04-01
Interventions
Spartan Stem, World Acetabular Cup and World Liner

Brief Summary

The aim of the study is to monitor the performance of the Signature Orthopaedics Spartan Stem, World Acetabular Cup and World Liner as a 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

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