Monitoring the performance of hip replacement devices

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Evaluating long-term outcomes of hip replacement surgeries

  This study is trying to see how well Corin hip replacement devices work and how safe they are for people getting hip surgery over the long term.

  Recruiting at 6 sites Corin · Bordeaux and 12 other locations · NCT02230826

• Monitoring the performance of hip implants after surgery

  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.

  Recruiting Signature Orthopaedics · Cleveland, Ohio · NCT06153940

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.