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

Active, not recruiting

• Conditions: Knee Arthropathy

• Registration Number: NCT04598568
• Lead Sponsor: Mathys Ltd Bettlach

Brief 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.

Study Timeline

• Study Start: 2012-05-15
• Primary Completion: 2015-12-07
• Status Verified: 2020-10
• Study First Submitted: 2020-10-15
• Study First Submitted QC: 2020-10-21
• Last Update Submitted: 2020-10-21
• Study First Posted: 2020-10-22
• Last Update Posted: 2020-10-22
• Study Completion: 2025-12-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• Informed consent form (signed by participant and investigator)
• Primary implantation
• Age at inclusion: Between 18 and 90 years old
• Willing to participate in the follow-up

Exclusion Criteria

• Missing Informed consent form
• Known or suspected non-compliance (e.g. drug or alcohol abuse)
• Enrollment of the investigator, his/her family, employees and other dependent persons
• Patient younger than 18 years old
• Revision surgery
• Does have a known allergy to metal in medical devices
• Suffers from ACL rupture
• Pregnancy or in the breast feeding period

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Knee Society Score	2 years	The primary endpoint of the study is the Knee Society Score (KSS) 2 years after surgery; The Knee Society Score consists of an objective score (0-100 points) and a score for function (0-100 points).; A higher score means a better outcome.

Secondary Outcome Measures

Name	Time	Method
Radiographic evaluation of lucent lines	6-12 weeks - 10 years	The second endpoint of interest is the incidence of lucent lines measured in millimeters by means of standard X-rays.
Adverse Events and Complications	6-12 weeks - 10 years	Documentation of complication(s): - Description of complication with the UKA; Documentation of component revision(s) (Adverse Events): * Reason(s) for revision(s); * Revised component(s)