NCT03610789

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 220 (estimated)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Retrospective-prospective, single arm, multicenter study of subjects previously implanted with the REDAPT System Monolithic Sleeveless/Sleeved Stem and/or Fully Porous Acetabular Shell with XLPE liner and/or Modular Shell Components (with or without Staple, Slice and Blade Augments).

Conditions

• Hip Replacement

Interventions

Type	Name	Description
DEVICE	REDAPT	REDAPT Monolithic Sleeveless Stems and Acetabular Cup Components

Timeline

• Start date: 2018-05-07
• Primary completion: 2034-07-01
• Completion: 2034-07-01
• First posted: 2018-08-01
• Last updated: 2025-01-06

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study