NCT06564636

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 119 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a multi-center, prospective, non-randomized study of subjects implanted with the CATALYSTEM™ Primary Hip System for primary Total Hip Arthroplasty (THA). Subjects will be enrolled and followed for 10 years post-operatively to assess safety and efficacy of the CATALYSTEM™ Primary Hip System. The primary objective is to assess 2-year post-operative stem survivorship of the Collared CATALYSTEM™ Hip System femoral stem with standard or high offset in primary THA procedures. Stem survivorship is defined as no aseptic revision (i.e., revision for any reason except infection) of the implanted femoral stem.

Conditions

• Total Hip Arthroplasty (THA)
• Osteoarthritis
• Degenerative Joint Disease
• Inflammatory Arthritis
• Avascular Necrosis
• Post-traumatic Arthritis
• Congenital Hip Dysplasia

Interventions

Type	Name	Description
DEVICE	CATALYSTEM	CATALYSTEM Cementless Primary Hip System for participants with Total Hip Arthroplasty

Timeline

• Start date: 2024-09-26
• Primary completion: 2027-12-01
• Completion: 2036-03-01
• First posted: 2024-08-21
• Last updated: 2026-03-12

Locations

10 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study