Status:
RECRUITING
Spartan Stem, World Cup and World Liner Post Market Clinical Follow-up Study
Lead Sponsor:
Signature Orthopaedics
Collaborating Sponsors:
The Cleveland Clinic
Conditions:
Hip Replacement
Eligibility:
All Genders
18-75 years
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.
Detailed Description
The objective of this PMCF Study is to collect data confirming safety, performance and clinical benefits of the Spartan Stem, World Acetabular Cup and the World Liner when used for primary total hip a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 8 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06172569
Start Date
December 8 2023
End Date
April 1 2028
Last Update
December 15 2023
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195