NCT04598568

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 116 (actual)
• Sponsor: Mathys Ltd Bettlach · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Knee Arthropathy

Interventions

Type	Name	Description
DEVICE	balanSys UNI	Implantation of a balanSys UNI knee prosthesis implanted with a spacer block surgical technique

Timeline

• Start date: 2012-05-15
• Primary completion: 2015-12-07
• Completion: 2025-12-14
• First posted: 2020-10-22
• Last updated: 2026-02-06