A Multi-Centre Study in Patients Undergoing Total Hip Arthroplasty With the Smith+Nephew CATALYSTEM™ Primary Hip System

Running, not enrolling

Conditions studied: Total Hip Arthroplasty (THA), Osteoarthritis, Degenerative Joint Disease, Inflammatory Arthritis, Avascular Necrosis, Post-traumatic Arthritis, Congenital Hip Dysplasia

In brief

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.

Key facts

Study ID

NCT06564636

Run by

Smith & Nephew, Inc.

People needed

119

Starts

2024-09-26

Expected to finish

2036-03-01

Last updated by the study team

2026-03-12

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• OR
• 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:
• Preoperative Patient Reported Outcome Measures (PROMs):
• Hip Disability and Osteoarthritis Outcome Score Junior (HOOS, JR.)
• European Quality of Life (EuroQol) Five-dimensional Five-level (EQ-5D-5L), and
• Radiographs have been obtained:
• ° Anterior Posterior (AP) Pelvis
• AP Hip*, and
• Lateral**
• 6-Weeks
• ° PROMs (HOOS, JR., and EQ-5D-5L), and
• Radiographs (AP Pelvis, AP Hip*, and Lateral**) have been obtained or these can be collected prospectively in window per schedule of events, and
• 1-Year
• ° PROMs (HOOS, JR., and EQ-5D-5L), and
• ° Radiographs (AP Pelvis, AP Hip*, and Lateral**) have been obtained or these can be collected prospectively in window per schedule of events
• Subject agrees to consent and to follow the prospective study visit schedule by signing the Independent Review Board (IRB)/Independent Ethics Committee (IEC) approved Informed Consent Form (ICF).
• Subject is eighteen to eighty (18-80) years old (inclusive).
• Subject can read, understand, and communicate responses to the PROMs.
• footnote:
• For the AP radiographs, Standing AP is preferred. For standardization, sites MUST ensure that positioning (standing AP or supine AP) is consistent across all study visits for subjects (i.e., if subject had standing AP at pre-op then collect standing AP at all visits).
• * Frog-lateral is preferred. However, lateral radiograph may include any one of the following: Cross-Table Lateral (CTL) or Frog-lateral or lateral femoral/Lauenstein. For standardization, sites MUST ensure consistency across all study visits for subjects (i.e., if subject had frog-leg lateral at pre-op then collect frog-leg lateral at all visits).
• Exclusion Criteria: Any one (1) of the following criteria will disqualify a potential subject from participation in the study:
• Subject has conditions that would eliminate or tend to eliminate adequate implant support or prevent the use of an appropriately-sized implant, e.g.:
• Blood supply limitations

Where it is running

• University of California at San Francisco — San Francisco, California, United States
• Connecticut Orthopaedic Institute — Hamden, Connecticut, United States
• Orlando Health Inc. — Orlando, Florida, United States
• Illinois Bone and Joint Institute — Des Plaines, Illinois, United States
• NYU Langone Health Orthopedic Hospital — New York, New York, United States
• Duke Health — Morrisville, North Carolina, United States
• University of Alberta — Edmonton, Alberta, Canada
• University of British Columbia — Vancouver, British Columbia, Canada
• Concordia General Hospital — Winnipeg, Manitoba, Canada
• London Health Sciences Centre (LHSC) — London, Ontario, Canada

Full record on ClinicalTrials.gov

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