Clinical trial NCT06657248: Clinical Performance and Safety of the Unicompartmental Univation® XF Pro Implant
Official title: Prospective, Multicenter Study Evaluating the Midterm Clinical Performance and Safety of the Unicompartmental Univation® XF Pro Knee Implant
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Gonarthritis
Degenerative Disease
Keywords: Degenerative medial unicompartmental Gonarthrosis
Unicompartmental knee arthroplasty
Safety and Performance
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
Collaborators: name: Raylytic GmbH
First posted: 2024-10-24
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients between 18 and 75 years of age with an indication for a primary medial unicompartmental knee endoprosthesis

Brief summary: The study is designed as a prospective, observational, mid-term, multi-center follow-up study. It is planned to include 150 patients from 4 different study centres in Germany. The product under investigation is used in routine clinical practice and according to the authorized Instructions for Use (IfU). The data that is obtained in routine clinical use will be documented in an electronical Case Report Form (eCRF). The study's main purpose is the collection of clinical data on the safety and performance of the redesigned univation® XF Pro implant.


Eligibility criteria: Inclusion Criteria:

* Indication for a primary medial unicompartmental knee endoprosthesis

Acc. to Instructions for Use:

* Both cruciate ligaments intact
* Lateral ligaments intact
* Leg axis amenable to passive correction
* Varus deformity under 15°
* Bending capability of at least 90°
* Extension deficit no greater than 5-10°
* Written informed consent of patient
* Kellgran \& Lawrence Score \> II (only straight or varus
* Patients with moderate radiological symptoms
* Patients without clinical symptoms

Exclusion Criteria:

* Pregnancy
* Patient age \<18 and \> 75 years
* BMI ≥ 40
* High risk patients ASA \> III

Primary outcomes:
measure: Functional patient-reported outcome
timeFrame: 5 years post-op
Secondary outcomes:
measure: Implant survival [Kaplan-Meier]
timeFrame: until 5 years postoperatively
measure: Quality of Life [EQ-5D-5L] compared to baseline
timeFrame: Preoperatively (baseline) and 3 months, 1 year, 2 years, 5 years postoperatively
measure: Progress of Clinical Outcome [Forgotten Joint Score-12] over follow-up period
timeFrame: 3 months, 1 year, 2 years, 5 years postoperatively
measure: Radiological assessment: axis alignment (long leg x-ray) over time
timeFrame: at discharge (approx. 7-10 days postoperatively), 3 months, 1 year, 2 years, 5 years postoperatively
measure: Radiological assessment: comparison of tibial slope over time
timeFrame: at discharge (approx. 7-10 days postoperatively), 3 months, 1 year, 2 years, 5 years postoperatively
measure: Radiological assessment: Patella x-ray
timeFrame: at discharge (approx. 7-10 days postoperatively), 3 months, 1 year, 2 years, 5 years postoperatively
measure: Number of Adverse events / serious adverse events over time
timeFrame: During the course of the study up to 5 years postoperatively
measure: Number of Participants with radiological complications over time
timeFrame: During the course of the study up to 5 years postoperatively
Other outcomes:
Locations:
city: Potsdam
country: Germany
facility: Oberlinklinik gGmbH
state: Brandenburg
city: Bünde
country: Germany
facility: Lukas Krankenhaus
state: Nordrhein-Westfalen
city: Brakel
country: Germany
facility: St. Vincenz Hospital Brakel
city: München
country: Germany
facility: LMU Großhadern
Study officials:
affiliation: St. Vincenz Hospital Brakel
name: Rolf Haaker, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: