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Everglade Stem, World Cup and World Liner Post Market Clinical Follow-up
RecruitingObservational study
Who can join
Ages 18 to 75 · All sexes
Full 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 AIDS or is receiving high dose of cortico-steroids. * patient has an emotional or neurological condition that would pre-empt their ability or unwillingness to participate in the clinical evaluation including mental illness, mental retardation or drug abuse * patient is severely overweight with a BMI\>40.
About the study
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.
What is being tested
- Treatment (device)
Sponsor: Signature Orthopaedics · Participants: 200 · Started: Nov 22, 2023
Contact the study team
- Satish A Shejale, M.S. Orthopaedics · Phone: +61 02 9428 5181
- Declan Brazil, PhD · Phone: +61 02 9428 5181
Official record on ClinicalTrials.gov — NCT06153940
Locations in the U.S.
| Ohio | Cleveland Clinic, Cleveland |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.