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

October 21, 2020 updated by: Mathys Ltd Bettlach
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

116

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

according to Eligibility Criteria

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
balanSys UNI knee prosthesis
Participants treated with a balanSys® UNI knee prosthesis
Device: balanSys UNI
Implantation of a balanSys UNI knee prosthesis implanted with a spacer block surgical technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6-12 weeks - 10 years
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)
6-12 weeks - 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mathys Ltd Bettlach

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 15, 2012

Primary Completion (ACTUAL)

December 7, 2015

Study Completion (ANTICIPATED)

December 7, 2025

Study Registration Dates

First Submitted

October 15, 2020

First Submitted That Met QC Criteria

October 21, 2020

First Posted (ACTUAL)

October 22, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 22, 2020

Last Update Submitted That Met QC Criteria

October 21, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20140206_Protocol_V5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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