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 Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04598568
• Other study ID #: 20140206_Protocol_V5
• Status: Active, not recruiting
• Start date: May 15, 2012
• Est. completion date: December 7, 2025

Study information

• Verified date: October 2020
• Source: Mathys Ltd Bettlach
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 116
• Est. completion date: December 7, 2025
• Est. primary completion date: December 7, 2015
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Joint Diseases
• Knee Arthropathy

Intervention

Device:
• balanSys UNI
Implantation of a balanSys UNI knee prosthesis implanted with a spacer block surgical technique

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mathys Ltd Bettlach

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Society Score	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.	2 years
Secondary	Radiographic evaluation of lucent lines	The second endpoint of interest is the incidence of lucent lines measured in millimeters by means of standard X-rays.	6-12 weeks - 10 years
Secondary	Adverse Events and Complications	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)	6-12 weeks - 10 years