Univation® X Follow-Up Study
Prospective Observational 2 Year Follow-up on a Retrospective Cohort of Primary Unicompartmental Knee Arthroplasty (UKA) Patients Treated With Univation® X or iUni®.
1 other identifier
observational
77
1 country
1
Brief Summary
The study is designed as a monocentric, prospective, observational, comparative follow-up study based on two previously treated patient groups. The first group consists of patients treated with the patient-specific unicondylar knee implant iUni®. For that group, 30 patients will be included in the study and analyzed. The final follow-up after 24 months has already been documented by the study center. Compared to that, a consecutive series of 50 Univation® X patients will be invited for a 24 months follow-up in 2018. In total, it is planned to include 80 retrospective patients for that historical control study design. The products under investigation were used in routine clinical practice and according to the authorized Instructions for Use (IfU). Those data that are obtained in routine clinical use will be documented in the Case Report Form (CRF).
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 Sep 2017
Typical duration for all trials
1 active site
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
First Submitted
Initial submission to the registry
May 23, 2017
CompletedFirst Posted
Study publicly available on registry
June 28, 2017
CompletedStudy Start
First participant enrolled
September 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2020
CompletedApril 15, 2021
April 1, 2021
2 years
May 23, 2017
April 14, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Knee joint function
Knee Society Score
2 years after primary implantation
Secondary Outcomes (4)
KOOS
2 years after primary implantation
axis justice position
preoperative and until discharge from hospital (within 1 week postoperatively)
radiolucent lines
2 years after primary implantation
tibial slope
2 years after primary implantation
Other Outcomes (1)
Adverse Events
2 years after primary implantation
Study Arms (2)
Univation® X
iUni®
Interventions
Primary implantation of an unicompartmental knee implant
Eligibility Criteria
adult patients
You may qualify if:
- Patients who underwent UKA in 2015/2016 (using one of the products under investigation)
- Signed informed consent
You may not qualify if:
- pregnancy
- patients \< 18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aesculap AGlead
Study Sites (1)
St. Vincenz Hospital Brakel
Brakel, 33034, Germany
Related Publications (1)
Haaker R, Moussa A, Sabev D. No advantage for patient-specific UKA in comparison with standard UKA regarding clinical and functional results at short-term follow-up. Eur J Orthop Surg Traumatol. 2025 Aug 27;35(1):362. doi: 10.1007/s00590-025-04467-2.
PMID: 40866508DERIVED
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2017
First Posted
June 28, 2017
Study Start
September 25, 2017
Primary Completion
September 30, 2019
Study Completion
April 1, 2020
Last Updated
April 15, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share