A Multi-Centre Study in Patients Undergoing Total Hip Arthroplasty With the Smith+Nephew CATALYST… (NCT06564636) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Multi-Centre Study in Patients Undergoing Total Hip Arthroplasty With the Smith+Nephew CATALYSTEM™ Primary Hip System
United States119 participantsStarted 2024-09-26
Plain-language summary
A Multi-Center Study in Patients Undergoing Total Hip Arthroplasty with the Smith+Nephew CATALYSTEM™ Primary Hip System. The purpose of the study is to assess safety and performance of the CATALYSTEM™ and to support product approval in global markets.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. a. Subject needing primary THA due to end stage degenerative joint disease (primary diagnosis of osteoarthritis), avascular necrosis, post-traumatic arthritis, inflammatory arthritis, or congenital hip dysplasia and, as part of standard of care, the surgeon determines that surgical treatment with the CATALYSTEM™ is the recommended implant for the subject.
✓. b. Subject has undergone primary THA with the S+N CATALYSTEM™ Primary Hip stem in the past 12 months for end stage degenerative joint disease (primary diagnosis of osteoarthritis), avascular necrosis, post-traumatic arthritis, inflammatory arthritis, or congenital hip dysplasia and all the following conditions have been met for the appropriate timepoint:
Exclusion criteria
âś•. Subject has conditions that would eliminate or tend to eliminate adequate implant support or prevent the use of an appropriately-sized implant, e.g.:
âś•. Subject has a Body Mass Index (BMI) \>/= 45 at time of surgery.
âś•. Subject has a known allergy to one or more components of the study device.
âś•. Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.55 (i.e., individuals who are unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response).
âś•. Subject is entered in another drug, biologic, or device study or has been treated with an investigational product 30 days prior to the surgery date.
âś•. Subject is known to be at risk for lost to follow-up, or failure to return for scheduled visits.
What they're measuring
1
Collared CATALYSTEM™ femoral stem implant survivorship 2 years post-operatively