NCT02344160

REDAPT Revision System Study to Assess 5 Year Revision Rate & up to 10 Year Revision Rate and Safety and Effectiveness

A Prospective, Multi-center Consecutive Series Study of Subjects Treated With the REDAPT™ Revision Femoral System

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to demonstrate non-inferiority of stem revision rate in subjects implanted with the REDAPT™ System with a revision rate of less than 9.8% at the 5 year mark assuming an observed rate of 6.5% at 5 years. Additional data will be collected as outcomes of safety and effectiveness data up to 10 years post REDAPT revision surgery.

Detailed description

This study is a prospective, multi-center, consecutive series study of subjects treated with REDAPT™. The safety and effectiveness of the REDAPT™ revision stem will be assessed over a maximum of 5 years with additional follow up to 10 years to assess outcomes. The objective of this study is to establish if the REDAPT™ stem revision rate is less than 9.8% at 5 years with an observed rate from literature review of 6.5% at 5 year.

Conditions

• Total Hip Arthroplasty (THA)

Interventions

Type	Name	Description
OTHER	Phlebotomy	Phlebotomy will be performed at study follow up visits to obtain blood for metal ion analysis which will monitor levels for safety outcome measures

Timeline

• Start date: 2014-12-01
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2015-01-22
• Last updated: 2016-12-16

Locations

1 site across 1 country: United States