GonarthritisUNI_XF_PRONCT06657248
Clinical Performance and Safety of the Unicompartmental Univation® XF Pro Implant
An observational study of Gonarthritis and Degenerative Disease, run by Aesculap AG at 4 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gonarthritis, Degenerative Disease
- What is being tested?
- univation® XF Pro
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 4 sitesGermany
- Study dates
- 2 Apr 2026to Oct 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients between 18 and 75 years of age with an indication for a primary medial unicompartmental knee endoprosthesis
Who may be able to join
- 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°
Show all 12Show fewer
- 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
Who cannot join
- Pregnancy
- Patient age <18 and > 75 years
- BMI ≥ 40
- High risk patients ASA > III
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany4 sites, 3 recruiting
- Withdrawn
St. Vincenz Hospital Brakel
Brakel, 33034
- Recruiting
Lukas Krankenhaus
Bünde, North Rhine-Westphalia, 32257
Michael Menges, Dr.
Michael Menges, Dr.
- Recruiting
LMU Großhadern
München, 81377
Peter Müller, Prof. Dr.
Peter Müller, Prof. Dr.
- Recruiting
Sportklinik Ravensburg
Ravensburg, 88214
Thomas Mattes, Dr.med.
Thomas Mattes, Dr.med.
About this study
Official title: 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.
Read the 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.
- Conditions
- Gonarthritis, Degenerative Disease
- Being tested
- univation® XF Pro
- Keywords
- Degenerative medial unicompartmental Gonarthrosis, Unicompartmental knee arthroplasty, Safety and Performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
univation® XF ProDevice
Also called Unicompartmental knee arthroplasty
Primary medial unicompartmental knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| univation® XF Pro | Primary medial unicompartmental knee arthroplasty treated with implantation of unicompartmental knee prosthesis univation® XF Pro Receives: Device: univation® XF Pro |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years post-op
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: at discharge (approx. 7-10 days postoperatively), 3 months, 1 year, 2 years, 5 years postoperatively
Radiological assessment: Patella x-ray
Measured: 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
Measured: 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.
Measured: During the course of the study up to 5 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start2 Apr 2026
- Primary completionOct 2027 (estimated)
- Study completionOct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GonarthritisStudies of the same condition, open and under way.
- More trials run by Aesculap AGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Raylytic GmbH
- Responsible party
- Sponsor
- Investigators
- Rolf Haaker, Prof. Dr., Principal investigator, St. Vincenz Hospital Brakel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657248
- Sponsor's protocol ID
- AAG-O-H-22003
- Acronym
- UNI_XF_PRO
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter Study Evaluating the Midterm Clinical Performance and Safety of the Unicompartmental Univation® XF Pro Knee Implant
- ClinicalTrials.gov ID
- NCT06657248
- Acronym / sponsor ID
- UNI_XF_PRO / AAG-O-H-22003
- Conditions
- Gonarthritis, Degenerative Disease
- Keywords
- Degenerative medial unicompartmental Gonarthrosis, Unicompartmental knee arthroplasty, Safety and Performance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Collaborators
- Raylytic GmbH
- Study start
- 2 Apr 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2032 (estimated)
- First posted
- 24 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| univation® XF Pro | – | Device: univation® XF ProPrimary medial unicompartmental knee arthroplasty treated with implantation of unicompartmental knee prosthesis univation® XF Pro |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients between 18 and 75 years of age with an indication for a primary medial unicompartmental knee endoprosthesis
Key inclusion criteria (12 listed)
- Indication for a primary medial unicompartmental knee endoprosthesis
- Both cruciate ligaments intact
- Lateral ligaments intact
- Leg axis amenable to passive correction
- Varus deformity under 15°
Key exclusion criteria (4 listed)
- Pregnancy
- Patient age <18 and > 75 years
- BMI ≥ 40
- High risk patients ASA > III
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| univation® XF ProAlso: Unicompartmental knee arthroplastyPrimary medial unicompartmental knee arthroplasty | Device | univation® XF Pro |
Primary outcome
Functional patient-reported outcome
Time frame: 5 years post-op
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rolf Haaker, Prof. Dr. principal investigator
St. Vincenz Hospital Brakel
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gonarthritis and Degenerative Disease, run by Aesculap AG at 4 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Petra Wain (+49746195, info@aesculap.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional patient-reported outcome (time frame: 5 years post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.