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OpenTrials
Completed

NCT Number: NCT04598568

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

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.

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Key information

Conditions

Knee Arthropathy

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

balanSys UNI

Device

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

Primary outcomes

  1. Knee Society Score

    Time frame: 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 outcomes

  1. Radiographic evaluation of lucent lines

    Time frame: 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.

  2. Adverse Events and Complications

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Mathys Ltd Bettlach

Industry

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2025
First posted
Oct 22, 2020
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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