Monitoring the performance of hip implants after surgery
Everglade Stem, World Cup and World Liner Post Market Clinical Follow-up
This study looks at how well certain hip implants work and how happy patients are with them after hip surgery over a couple of years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Signature Orthopaedics Industry-sponsored |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06153940 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect data on the safety and performance of the Everglade Stem, World Acetabular Cup, and World Liner used in primary total hip arthroplasty. It involves a prospective follow-up of patients at various time points, including pre-operative, discharge, one year, and two years post-operative evaluations. The primary objective is to monitor the revision rate of the implants and assess patient satisfaction through the Oxford Hip Score, alongside radiographic analysis to evaluate the effectiveness of cementless fixation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 requiring unilateral primary total hip arthroplasty due to non-inflammatory degenerative joint diseases.
Not a fit: Patients with active infections, inadequate bone stock, known metal sensitivities, or those who are immuno-suppressed may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety and effectiveness of these hip implants, potentially improving patient outcomes.
How similar studies have performed: Other studies on post-market clinical follow-up of orthopedic implants have shown success in confirming safety and performance, making this approach well-supported.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Nicolas Piuzzi, MD — The Cleveland Clinic
- Study coordinator: Satish A Shejale, M.S. Orthopaedics
- Email: satish.shejale@signatureortho.com.au
- Phone: +61 02 9428 5181
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.