Everglade Stem, World Cup and World Liner Post Market Clinical Follow-up
Recruiting now
Conditions studied: Hip Disease
In brief
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.
Key facts
- Study ID
- NCT06153940
- Run by
- Signature Orthopaedics
- People needed
- 200
- Starts
- 2023-11-22
- Expected to finish
- 2028-03-01
- Last updated by the study team
- 2023-12-01
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
Full record on ClinicalTrials.gov
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