Post-market Clinical Follow-up on the balanSys UNI Knee Prosthesis Implanted With a Spacer Block Surgical Technique
1 other identifier
observational
116
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2012
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 15, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 7, 2015
CompletedFirst Submitted
Initial submission to the registry
October 15, 2020
CompletedFirst Posted
Study publicly available on registry
October 22, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 14, 2025
CompletedFebruary 6, 2026
February 1, 2026
3.6 years
October 15, 2020
February 5, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Radiographic evaluation of lucent lines
6-12 weeks - 10 years
Adverse Events and Complications
6-12 weeks - 10 years
Study Arms (1)
balanSys UNI knee prosthesis
Participants treated with a balanSys® UNI knee prosthesis
Interventions
Implantation of a balanSys UNI knee prosthesis implanted with a spacer block surgical technique
Eligibility Criteria
according to Eligibility Criteria
You may qualify if:
- Informed consent form (signed by participant and investigator)
- Primary implantation
- Willing to participate in the follow-up
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 33810795DERIVED
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2020
First Posted
October 22, 2020
Study Start
May 15, 2012
Primary Completion
December 7, 2015
Study Completion
December 14, 2025
Last Updated
February 6, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share