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)
Everglade Stem, World Cup and World Liner Survival Rate — upto 2 years The implant survival rate based on removal of the device for any reason as determined following the Kaplan-Meier method
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.
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