A Multicenter, Post-Market Clinical Follow-up Study of Subjects With the REDAPT™ System Monolithic Sleeveless/Sleeved Stem and/or Fully Porous Acetabular Shell With XLPE Liner and/or Modular Shell Components Previously Implanted
NCT03610789 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 220
Last updated 2025-01-06
Summary
The primary purpose of this study is to demonstrate cumulative revision rate of the REDAPT System Monolithic Sleeveless/Sleeved Stem, Fully Porous Acetabular Shell with XLPE liner, and Modular Shell Components (with or without Staple, Slice and Blade Augments) at 10 years.
Conditions
- Hip Replacement
Interventions
- DEVICE
-
REDAPT
REDAPT Monolithic Sleeveless Stems and Acetabular Cup Components
Sponsors & Collaborators
-
Smith & Nephew, Inc.
lead INDUSTRY
Principal Investigators
-
Nahomie Prophete · Smith & Nephew, Inc.
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-05-07
- Primary Completion
- 2034-07-01
- Completion
- 2034-07-01
- FDA Device
- Yes
Countries
- United States
Study Locations
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