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Clinical Trials in the USA / NCT06153940
Recruiting Observational

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

NCT06153940 · tracked via the Priya Life Science USA tracker
Sponsor
Signature Orthopaedics
Phase
Observational
Started
2023-11-22
Last updated
2023-12-01

Condition(s) studied

Hip Disease

Investigational drug(s) / intervention(s)

Treatment

Treatment: The Everglade™ Stem, is a second generation cementless blade style hip stem Forged in Titanium and proximally Antero-Posterior (AP) flared with Titanium Plasma Spray + Hydroxyapatite (TPS + HA) coated for bone on-growth. The stem has distal geometry and a polished anodized surface finish to minimize the stem hanging in Dorr A femurs. The World Acetabular Cup is a porous coated and mated with the Cross-linked polyethylene World Liner

Study summary

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.

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)

Trial sites (1)

FacilityCityRegionStatus
Cleveland Clinic Cleveland Ohio Recruiting

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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 NCT06153940 on ClinicalTrials.gov ↗ ← All trials in the USA