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Recruiting Observational

Spartan Stem, World Cup and World Liner Post Market Clinical Follow-up Study

NCT06172569 · tracked via the Priya Life Science USA tracker
Sponsor
Signature Orthopaedics
Phase
Observational
Started
2023-12-08
Last updated
2023-12-15

Condition(s) studied

Hip Replacement

Investigational drug(s) / intervention(s)

Spartan Stem, World Acetabular Cup and World Liner

Spartan 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

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Spartan Stem, World Acetabular Cup and World Liner Survival Rate — up to 2 years
    The implant survival rate is based on removal of the device for any reason as determined following the Kaplan-Meier method.

Trial sites (1)

FacilityCityRegionStatus
Cleveland Clinic Cleveland Ohio Recruiting

More Signature Orthopaedics trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06172569 on ClinicalTrials.gov ↗ ← All trials in the USA