An observational study in Unicompartmental Knee Arthroplasty, sponsored by Aesculap AG. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-15.
Sponsored by Aesculap AG · Observational
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).
Aesculap AG is the lead sponsor of 104 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
adult patients
Exclusion Criteria:
Device: Primary Unicompartmental Knee Arthroplasty
Device: Primary Unicompartmental Knee Arthroplasty
Primary implantation of an unicompartmental knee implant
Knee joint function
Knee Society Score
Time frame: 2 years after primary implantation
KOOS
Knee Injury and Osteoarthritis Outcome Score
Time frame: 2 years after primary implantation
axis justice position
radiological analysis
Time frame: preoperative and until discharge from hospital (within 1 week postoperatively)
radiolucent lines
radiological analysis
Time frame: 2 years after primary implantation
tibial slope
radiological analysis
Time frame: 2 years after primary implantation
Adverse Events
Number of Adverse Events during Follow-Up
Time frame: 2 years after primary implantation
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Aesculap AG