Clinical Performance and Safety of the Unicompartmental Univation® XF Pro Implant (UNI_XF_PRO)

Prospective, Multicenter Study Evaluating the Midterm Clinical Performance and Safety of the Unicompartmental Univation® XF Pro Knee Implant

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.

Study Overview

• Status: Recruiting
• Conditions: Gonarthritis; Degenerative Disease
• Intervention / Treatment: Device: univation® XF Pro

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Stefan Maenz, Dr.; Phone Number: +49746195; Email: info@aesculap.de
• Study Contact Backup: Name: Petra Wain; Phone Number: +49746195; Email: info@aesculap.de

Study Locations

• Germany
  • Brakel, Germany, 33034
    • Recruiting
    • St. Vincenz Hospital Brakel
    • Contact: Rolf Haaker, Prof. Dr.
  • München, Germany, 81377
    • Not yet recruiting
    • LMU Großhadern
    • Contact: Peter Müller, Prof. Dr.
    • Principal Investigator: Peter Müller, Prof. Dr.
  • Brandenburg
    • Potsdam, Brandenburg, Germany, 14482
      • Not yet recruiting
      • Oberlinklinik gGmbH
      • Contact: Robert Krause, Dr.
      • Principal Investigator: Robert Krause, Dr.
  • North Rhine-Westphalia
    • Bünde, North Rhine-Westphalia, Germany, 32257
      • Not yet recruiting
      • Lukas Krankenhaus
      • Contact: Michael Menges, Dr.
      • Principal Investigator: Michael Menges, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
univation® XF Pro; Primary medial unicompartmental knee arthroplasty treated with implantation of unicompartmental knee prosthesis univation® XF Pro	Device: univation® XF Pro; Primary medial unicompartmental knee arthroplasty; Other Names: Unicompartmental knee arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional patient-reported outcome	The Oxford Knee Score (OKS) is a reliable 12-item, patient-reported questionnaire originally developed and validated specifically to assess function and pain in patients undergoing total knee replacement. It is short, reproducible, valid and sensitive to clinically important changes over time. Each of the 12 questions on the OKS is scored in the same way with the score decreasing as the reported symptoms increase (i.e. become worse). All questions are laid out with response categories denoting least (or no) symptoms to the left of the page (scoring 4) and those representing greatest severity lying on the right hand side (scoring 0), as detailed for question 1 below. This method, when summed, produces overall scores running from 0 to 48 with 48 being the best outcome.	5 years post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant survival [Kaplan-Meier]	Kaplan-Meier Analysis is a standard statistical method to describe the survival of human subjects or medical products over a defined time period.	until 5 years postoperatively
Quality of Life [EQ-5D-5L] compared to baseline	The 5-dimension 5-level measure of the health status, developed by the EuroQol Group (EQ-5D-5L) is a simple and generic measure for clinical and economic assessment. Instructions for the user are directly included into the questionnaire and it consists of two pages. One cover five different dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression) and the other one the EQ visual Analogue Scale (EQ-VAS). The VAS scale records the self rated health status of the patient from the level "the worst health you can imagine" to "the best health you can imagine". The answer of each of the five dimensions result in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.	Preoperatively (baseline) and 3 months, 1 year, 2 years, 5 years postoperatively
Progress of Clinical Outcome [Forgotten Joint Score-12] over follow-up period	The Forgotten Joint Score-12 (FJS-12) Knee was designed to assess patient outcome in patients undergoing conservative or operative treatment of the knee. These Patient Reported Outcome (PRO) questionnaires focus on patients' awareness of a specific joint in everyday life. In 12 Items the awareness for the artificial joint is assessed by the patient, each on a five point scale (Never / Almost Never / Seldom / Sometimes / Mostly) The Forgotten Joint Score assessment consists of 12 questions and is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities	3 months, 1 year, 2 years, 5 years postoperatively
Radiological assessment: axis alignment (long leg x-ray) over time	Radiographs shall be standardized between centres as far as possible. Unless limited by patient or equipment constraints, all follow-up imaging examinations will be obtained according to the radiographic protocol of the hospital and the set routine. The radiographic evaluation of Alignment is based on long-leg x-rays	at discharge (approx. 7-10 days postoperatively), 3 months, 1 year, 2 years, 5 years postoperatively
Radiological assessment: comparison of tibial slope over time	Radiographs shall be standardized between centres as far as possible. Unless limited by patient or equipment constraints, all follow-up imaging examinations will be obtained according to the radiographic protocol of the hospital and the set routine. Any changes of Tibial slope over the follow-up period is documented in the radiographic evaluation	at discharge (approx. 7-10 days postoperatively), 3 months, 1 year, 2 years, 5 years postoperatively
Radiological assessment: Patella x-ray		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	During the course of the study, any upcoming intra- or postoperative (serious) adverse events (AE / SAE) or device effects related or not related to the product under investigation or the procedure, will be documented in the dedicated Case Report Forms. The total number of AEs will be summarized and further evaluated by the sponsor and reported according to local legislation and necessity. Recorded complications will be categorized and analyzed in order to assess the safety of the investigational product	During the course of the study up to 5 years postoperatively
Number of Participants with radiological complications over time	Radiographs shall be standardized between centres as far as possible. Unless limited by patient or equipment constraints, all follow-up imaging examinations will be obtained according to the radiographic protocol of the hospital and the set routine. All radiologically evident complications (including fracture, wear, loosening or radiolucencies) are cumulatively documented over the period of follow-up.	During the course of the study up to 5 years postoperatively

Collaborators and Investigators

• Sponsor: Aesculap AG
• Collaborators: Raylytic GmbH
• Investigators: Principal Investigator: Rolf Haaker, Prof. Dr., St. Vincenz Hospital Brakel

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2032

Study Registration Dates

• First Submitted: October 23, 2024
• First Submitted That Met QC Criteria: October 23, 2024
• First Posted (Actual): October 24, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Unicompartmental knee arthroplasty; Safety and Performance; Degenerative medial unicompartmental Gonarthrosis
• Additional Relevant MeSH Terms: Surgical Procedures, Operative; Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Plastic Surgery Procedures; Prosthesis Implantation; Arthroplasty, Replacement, Knee
• Other Study ID Numbers: AAG-O-H-22003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No