Monitoring the performance of hip replacement devices
Spartan Stem, World Cup and World Liner Post Market Clinical Follow-up Study
This study is testing how safe and effective new hip replacement devices are for patients getting hip surgery by tracking their progress before and after the operation.
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 | NCT06172569 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety and effectiveness of the Signature Orthopaedics Spartan Stem, World Acetabular Cup, and World Liner in patients undergoing primary total hip arthroplasty. Data will be collected at various stages, including pre-operative, operative, discharge, and one year post-operative evaluations, focusing on the revision rate and patient-reported outcomes. The study will also analyze radiographic data to evaluate the bony response to the implants and the effectiveness of cementless fixation over a two-year follow-up period.
Who should consider this trial
Good fit: Ideal candidates are males and non-pregnant females aged 18-75 requiring unilateral primary total hip arthroplasty due to non-inflammatory degenerative joint disease.
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 enhance the understanding of hip replacement device performance, leading to improved patient outcomes.
How similar studies have performed: Other studies have shown success in monitoring hip replacement devices, indicating that this approach is supported by previous findings.
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 Shejale, MS Ortho
- 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.