Clinical Performance and Safety of the Unicompartmental Univation® XF Pro Implant
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: univation® XF Pro.
- Who it may be relevant to
- Registry conditions: Gonarthritis, Degenerative Disease. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective, Multicenter Study Evaluating the Midterm Clinical Performance and Safety of the Unicompartmental Univation® XF Pro Knee Implant
Overview
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.
Detailed description
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.
Interventions
- Device univation® XF Pro
Primary medial unicompartmental knee arthroplasty
Primary outcome measures
- Functional patient-reported outcome [Time frame: 5 years post-op]
Secondary outcome measures (8)
- Implant survival [Kaplan-Meier] [Time frame: until 5 years postoperatively]
- Quality of Life [EQ-5D-5L] compared to baseline [Time frame: Preoperatively (baseline) and 3 months, 1 year, 2 years, 5 years postoperatively]
- Progress of Clinical Outcome [Forgotten Joint Score-12] over follow-up period [Time frame: 3 months, 1 year, 2 years, 5 years postoperatively]
- Radiological assessment: axis alignment (long leg x-ray) over time [Time frame: at discharge (approx. 7-10 days postoperatively), 3 months, 1 year, 2 years, 5 years postoperatively]
- Radiological assessment: comparison of tibial slope over time [Time frame: at discharge (approx. 7-10 days postoperatively), 3 months, 1 year, 2 years, 5 years postoperatively]
- Radiological assessment: Patella x-ray [Time frame: at discharge (approx. 7-10 days postoperatively), 3 months, 1 year, 2 years, 5 years postoperatively]
- Number of Adverse events / serious adverse events over time [Time frame: During the course of the study up to 5 years postoperatively]
- Number of Participants with radiological complications over time [Time frame: During the course of the study up to 5 years postoperatively]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-control
Study locations
Germany · 4 centers
- Oberlinklinik gGmbH — Potsdam
- Lukas Krankenhaus — Bünde
- St. Vincenz Hospital Brakel — Brakel
- LMU Großhadern — München
Identifiers
NCT: NCT06657248 · AAG-O-H-22003