RecruitingNCT06172569
Spartan Stem, World Cup and World Liner Post Market Clinical Follow-up Study
Sponsor
Signature Orthopaedics
Enrollment
200 participants
Start Date
Dec 8, 2023
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria4
- 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 Criteria7
- 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.
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Interventions
DEVICESpartan Stem, World Acetabular Cup and World Liner
The Spartan Stem is a wedge-shaped fit and fill design stem with Titanium Plasma Spray(TPS) and Hydroxyapatite (HA) coating. The World Acetabular cup is Porous coated and mated with cross-linked polyethylene World Liner
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06172569