NCT06657248

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
78mo left

Started Mar 2026

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Mar 2026Oct 2032

First Submitted

Initial submission to the registry

October 23, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 24, 2024

Completed
1.4 years until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2032

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

1.6 years

First QC Date

October 23, 2024

Last Update Submit

February 25, 2026

Conditions

GonarthritisDegenerative Disease

Keywords

Degenerative medial unicompartmental GonarthrosisUnicompartmental knee arthroplastySafety and Performance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Implant survival [Kaplan-Meier]

    until 5 years postoperatively

  • Quality of Life [EQ-5D-5L] compared to baseline

    Preoperatively (baseline) and 3 months, 1 year, 2 years, 5 years postoperatively

  • Progress of Clinical Outcome [Forgotten Joint Score-12] over follow-up period

    3 months, 1 year, 2 years, 5 years postoperatively

  • Radiological assessment: axis alignment (long leg x-ray) over time

    at discharge (approx. 7-10 days postoperatively), 3 months, 1 year, 2 years, 5 years postoperatively

  • Radiological assessment: comparison of tibial slope over time

    at discharge (approx. 7-10 days postoperatively), 3 months, 1 year, 2 years, 5 years postoperatively

  • +3 more secondary outcomes

Study Arms (1)

univation® XF Pro

Primary medial unicompartmental knee arthroplasty treated with implantation of unicompartmental knee prosthesis univation® XF Pro

Device: univation® XF Pro

Interventions

univation® XF ProDEVICE

Primary medial unicompartmental knee arthroplasty

Also known as: Unicompartmental knee arthroplasty
univation® XF Pro

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients between 18 and 75 years of age with an indication for a primary medial unicompartmental knee endoprosthesis

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Oberlinklinik gGmbH

Potsdam, Brandenburg, 14482, Germany

Location

Lukas Krankenhaus

Bünde, North Rhine-Westphalia, 32257, Germany

Location

St. Vincenz Hospital Brakel

Brakel, 33034, Germany

Location

LMU Großhadern

München, 81377, Germany

Location

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Rolf Haaker, Prof. Dr.

    St. Vincenz Hospital Brakel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Petra Wain

CONTACT

+49746195info@aesculap.de

Stefan Maenz, Dr.

CONTACT

+49746195info@aesculap.de

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2024

First Posted

October 24, 2024

Study Start

March 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2032

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations

DE(4)