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Post-market Clinical Follow-up on the balanSys UNI Knee Prosthesis Implanted With a Spacer Block Surgical Technique

Knee Arthropathy Clinical Trial

Official title:
Post-market Clinical Follow-up on the balanSys UNI Knee Prosthesis Implanted With a Spacer Block Surgical Technique

Clinical Trial Summary

The purpose of the study is the evaluation of the clinical and radiological long-term performance of the balanSys UNI fix in a multicenter routine clinical setting.

Clinical Trial Description

Prospective multicenter follow-up study which examines the short- to long-term post-market clinical data on the safety and performance of the balanSys UNI fix knee prosthesis. In total at least 100 participants in 3 clinics are included in this multicenter study. The primary endpoint of the study is the Knee Society Score (KSS) 2 years after surgery. The following parameters will be collected during the regular clinical and radiological follow-up: Knee Society Score, Knee and Osteoarthritis Outcome Score (KOOS), radiographic evaluation and detection of adverse events. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04598568
Study type Observational
Source Mathys Ltd Bettlach
Contact
Status Active, not recruiting
Phase
Start date May 15, 2012
Completion date December 7, 2025
View Details
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