Knee ArthropathyNCT04598568
Post-market Clinical Follow-up on the balanSys UNI Knee Prosthesis Implanted With a Spacer Block Surgical Technique
An observational study of Knee Arthropathy, run by Mathys Ltd Bettlach.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Knee Arthropathy
- What is being tested?
- balanSys UNI
- Type of treatment
- Medical device
- How many people
- 116 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2012to 14 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: according to Eligibility Criteria
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the 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
- Being tested
- balanSys UNI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balanSys UNIDevice
Implantation of a balanSys UNI knee prosthesis implanted with a spacer block surgical technique
| Study group | Role | What they receive |
|---|---|---|
| balanSys UNI knee prosthesis | Participants treated with a balanSys® UNI knee prosthesis Receives: Device: balanSys UNI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (2)
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.
Measured: 6-12 weeks - 10 years
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)
Measured: 6-12 weeks - 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start15 May 2012
- Primary completion7 Dec 2015
- Study completion14 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee ArthropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mathys Ltd Bettlach
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04598568
- Sponsor's protocol ID
- 20140206_Protocol_V5
- Status last verified
- Feb 2026
- First submitted
- 15 Oct 2020
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tille E, Beyer F, Auerbach K, Tinius M, Lutzner J. Better short-term function after unicompartmental compared to total knee arthroplasty. BMC Musculoskelet Disord. 2021 Apr 2;22(1):326. doi: 10.1186/s12891-021-04185-w.
PubMed 33810795
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Clinical Follow-up on the balanSys UNI Knee Prosthesis Implanted With a Spacer Block Surgical Technique
- ClinicalTrials.gov ID
- NCT04598568
- Acronym / sponsor ID
- 20140206_Protocol_V5
- Conditions
- Knee Arthropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Mathys Ltd BettlachIndustry (pharma, biotech, devices)
- Study start
- 15 May 2012 (actual)
- Primary completion
- 7 Dec 2015 (actual)
- Study completion
- 14 Dec 2025 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| balanSys UNI knee prosthesis | – | Device: balanSys UNIParticipants treated with a balanSys® UNI knee prosthesis |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- according to Eligibility Criteria
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| balanSys UNIImplantation of a balanSys UNI knee prosthesis implanted with a spacer block surgical technique | Device | balanSys UNI knee prosthesis |
Primary outcome
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 secondary outcomes
Radiographic evaluation of lucent lines
Time frame: 6-12 weeks - 10 years
Adverse Events and Complications
Time frame: 6-12 weeks - 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Derived from this study: PubMed 33810795Tille E, Beyer F, Auerbach K, Tinius M, Lutzner J. Better short-term function after unicompartmental compared to total knee arthroplasty. BMC Musculoskelet Disord. 2021 Apr 2;22(1):326. doi: 10.1186/s12891-021-04185-w.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Arthropathy, run by Mathys Ltd Bettlach.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Society Score (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04598568, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.