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.
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.
Study Type
OBSERVATIONAL
Phlebotomy will be performed at study follow up visits to obtain blood for metal ion analysis which will monitor levels for safety outcome measures
Ran Schwarzkopf
Irvine, California, United States
Stem revision
the primary outcome will be assessed by the incidence of stem revision
Time frame: 5 years with additional follow up to 10 years
Revision for any reason
Revision for any reason
Time frame: 5 years with additional follow-up to 10 years
Radiographic Measurements
radiographic measurements to assess linear radiolucencies and subsidence to assess safety and potential change over time.
Time frame: post operatively with additional follow-up to 10 years
Hip Disability and Osteoarthritis Outcome Score (HOOS) and Euro Group Questionnaire (EQ-5D)
Subject reported outcomes will be collected and scored over time to assess change over time from baseline to 10 year post REDAPT Revision surgery
Time frame: At baseline and up to 10 year follow up
Harris Hip Score
Clinical evaluations to score and assess changes over time from baseline to 10 year follow up post REDAPT Revision surgery
Time frame: at baseline and follow up visits up to 10 year follow up post surgically
Number of participants with Adverse Events
Adverse events will be collected to monitor safety
Time frame: Adverse events will be collected and assessed as safety out come at each study visit up to 10 years post surgery
Metal Ion measurement in whole blood
blood will be analysed for metal ion levels at baseline and each study visit up to 10 years to assess change in serum metal ion level over time.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: baseline and at each study visit up to 10 years following REDAPT REvison surgery.