Last updated: December 7, 2023
Sponsor: Signature Orthopaedics
Overall Status: Active - Recruiting
Phase
N/A
Condition
Orthopedic Surgery
Hip Replacement
Treatment
Spartan Stem, World Acetabular Cup and World Liner
Clinical Study ID
NCT06172569
111-440-100
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- patient requires unilateral primary total hip arthroplasty due to non-inflammatorydegenerative joint disease (e.g., osteoarthritis, traumatic arthritis, avascularnecrosis, dysplasia/DDH)
- patient must be a candidate for use of the products studied, as determined jointly bythe surgeon and patient.
- male and non-pregnant female patients aged 18-75
- patients who understand the conditions of the clinical evaluation and are willing toparticipate for the length of the prescribed follow-up.
Exclusion
Exclusion Criteria:
- patient has active infection or sepsis(treated or untreated) enough to compromiseimplant stability or postoperative recovery
- patient is a female of child-bearing age and not taking and not taking contraceptivepills
- 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 ofcortico-steroids.
- patient has an emotional or neurological condition that would pre-empt their abilityor unwillingness to participate in the clinical evaluation including mental illness,mental retardation or drug abuse
- patient is severely overweight with a BMI>40.
Study Design
Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Spartan Stem, World Acetabular Cup and World Liner
Phase:
Study Start date:
December 08, 2023
Estimated Completion Date:
April 01, 2028
Study Description
Connect with a study center
Cleveland Clinic
Cleveland, Ohio 44195
United StatesActive - Recruiting
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