NCT07677722

Brief Summary

This prospective study aims to systematically compare the clinical and radiological outcomes and complications of mobile versus fixed unicompartimental knee prostheses.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
41mo left

Started Dec 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
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 Progress17%
Dec 2025Dec 2029

Study Start

First participant enrolled

December 8, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 1, 2026

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

July 1, 2026

Status Verified

June 1, 2026

Enrollment Period

4.1 years

First QC Date

June 11, 2026

Last Update Submit

June 25, 2026

Conditions

Medial Gonarthrosis

Outcome Measures

Primary Outcomes (1)

  • OKS

    Oxford Knee Score

    Preoperatively, 6 weeks, 4 months, 12 months, and 24 months postoperatively.

Secondary Outcomes (12)

  • AMI

    Evaluate AMI (Arthrogenic Muscle Inhibition) preoperative, at 6 weeks and 4 months postoperative.

  • Surgery time

    Peroperatively

  • Complications

    Within 2 years postoperatively

  • Revision or reoperation

    Within 2 years postoperatively

  • c-FCA

    6 weeks and 4 months postoperatively

  • +7 more secondary outcomes

Study Arms (2)

Mobile UKP

Mobile unicompartmental knee prosthesis

Fixed UKP

Fixed unicompartmental knee prosthesis

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients eligible for a unicompartmental medial knee prosthesis based on the eligibility criteria.

You may qualify if:

  • Age between 50 and 80 years
  • Indication for medial UKP
  • Intact anterior cruciate ligament
  • Good bone quality based on imaging
  • ASA score ≤ 3

You may not qualify if:

  • Inflammatory joint diseases
  • Collateral ligament instability
  • Simultaneous bilateral procedure
  • BMI \> 35
  • History of fracture or osteotomy in the knee joint
  • Neuromuscular diseases
  • Oncological indications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopedic department

Ieper, Oost-Vlaanderen, 8900, Belgium

RECRUITING

Central Study Contacts

Lenka Stroobant

CONTACT

+32496867115lenka.stroobant@ugent.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD-PhD

Study Record Dates

First Submitted

June 11, 2026

First Posted

July 1, 2026

Study Start

December 8, 2025

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

July 1, 2026

Record last verified: 2026-06

Locations

BE(1)