Exception Cementless Hip Stem — Exception  

Rheumatoid Arthritis Clinical Trial

Official title: Exception Cementless Femoral Stem in Total Hip Arthroplasty. A Multicenter, Retrospective and Prospective, Non-controlled Post Market Clinical Follow-up Study (Implants and Instrumentation)

Status Active, not recruiting

Clinical Trial Summary

This study is a multicenter, retrospective and prospective, non-controlled, non-randomized post market clinical follow-up study. The objectives of this study are to confirm the long-term safety, performance and clinical benefits the Exception Cementless femoral stem (standard and varized) when used in primary total hip arthroplasty.

Clinical Trial Description

Six surgeons have prospectively collected clinical data for patients operated consecutively between January 2008 and September 2012. The patients have been operated based on the indications and contraindications listed in the Instructions For Use (IFUs) of the implant.

This study is an extension of the surgeons' data collection as an attempt from Zimmer-Biomet to fulfill its post-market surveillance obligations by recovering clinical data retrospectively and prospectively.

Study Procedure Flowchart - retrospective data collection: most patients had clinical follow-ups at pre-op, operative, immediate post-op, 3 Months, 1 year, 2, 3, 5, 7 years post-surgery during which their surgeons collected clinical data. This data will therefore only be collected by Zimmer-Biomet after the patients specifically consent to it.

Study Procedure Flowchart - prospective data collection: The informed consent signed by the patient for this study also allow Zimmer Biomet to collect the data of the standard clinical follow-up that will be conducted by the investigators at least 10 years post-surgery. ;

Related Conditions & MeSH terms

• Arthritis
• Avascular Necrosis of Hip
• Congenital Hip Dysplasia
• Developmental Dysplasia of the Hip
• Femoral Neck Fractures
• Hip Dislocation
• Hip Dislocation, Congenital
• Inflammatory Arthritis
• Necrosis
• Osteoarthritis, Hip
• Rheumatoid Arthritis

• NCT number: NCT04349046
• Study type: Observational
• Source: Zimmer Biomet
• Status: Active, not recruiting
• Start date: January 1, 2021
• Completion date: December 2025