Medial GonarthrosisFiMo_UKPNCT07677722
Prospective Comparative Study of Clinical Outcomes and Complications in Medial Knee Prostheses: Fixed Bearing Versus Mobile Bearing Design
An observational study of Medial Gonarthrosis, run by Jan Yperman Hospital at 1 site in Belgium.
Trial summary
This prospective study aims to systematically compare the clinical and radiological outcomes and complications of mobile versus fixed unicompartimental knee prostheses. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Medial Gonarthrosis
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Dec 2025to 31 Dec 2029
- How long will I take part?
- 2 Years
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients eligible for a unicompartmental medial knee prosthesis based on the eligibility criteria.
Who may be able to join
- Age between 50 and 80 years
- Indication for medial UKP
- Intact anterior cruciate ligament
- Good bone quality based on imaging
- ASA score ≤ 3
Who cannot join
- Inflammatory joint diseases
- Collateral ligament instability
- Simultaneous bilateral procedure
- BMI > 35
- History of fracture or osteotomy in the knee joint
- Neuromuscular diseases
- Oncological indications
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Orthopedic department
Ieper, Oost-Vlaanderen, 8900
Francois Hardeman, MD, 057 35 73 70, francois.hardeman@yperman.net
About this study
This prospective study aims to systematically compare the clinical and radiological outcomes and complications of mobile versus fixed unicompartimental knee prostheses.
Read the detailed description
In knee surgery, two dominant designs exist for the medial unicompartmental knee prosthesis (UKP): the fixed bearing (FB) and mobile bearing (MB) designs. The FB design is technically simpler to implant but has shown higher rates of early polyethylene wear in some studies. MB implants theoretically offer advantages in joint kinematics and load distribution but carry a risk of insert dislocation and periprosthetic fractures. An additional advantage of MB implants is the possibility of cementless implantation, potentially avoiding cement-related complications and reducing operative time.
- Conditions
- Medial Gonarthrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mobile UKP | Mobile unicompartmental knee prosthesis | |
| Fixed UKP | Fixed unicompartmental knee prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
OKS
Oxford Knee Score
Measured: Preoperatively, 6 weeks, 4 months, 12 months, and 24 months postoperatively.
Secondary outcomes (12)
AMI
Arthrogenic Muscle Inhibition - DOI: 10.1002/ksa.12804 for grading
Measured: Evaluate AMI (Arthrogenic Muscle Inhibition) preoperative, at 6 weeks and 4 months postoperative.
Surgery time
Operative time
Measured: Peroperatively
Complications
Postoperative complications
Measured: Within 2 years postoperatively
Revision or reoperation
Revision or reoperation
Measured: Within 2 years postoperatively
c-FCA
Coronal Femoral Component Alignment - Varus/valgus alignment for the femoral component is measured on the AP radiograph in relation to the anatomical axis of the tibia. 0° degrees is considered neutral.
Measured: 6 weeks and 4 months postoperatively
EQ-5D-5L
The 5-level EQ-5D version.
Measured: Preoperatively, 6 weeks, 4 months, 12 months, and 24 months postoperatively.
NRS
Numeric Rating Scale
Measured: Preoperatively, one week, 6 weeks, 4 months, 12 months, and 24 months postoperatively.]
KOOS-PS
Knee Injury and Osteoarthritis Outcome Score-Physical function Short form
Measured: Preoperatively, 6 weeks, 4 months, 12 months, and 24 months postoperatively.
c-TCA
Coronal Tibial Component Alignment - Varus/valgus alignment for the tibial component is measured on the AP radiograph in relation to the anatomical axis of the tibia. 0° is considered neutral.
Measured: 6 weeks and 4 months postoperatively
s-FCA
Sagittal Femoral Component Alignment - Flexion/extension is measured on a lateral radiograph, relative to the posterior tibial cortex. A posteroinferior slope of 7° is considered neutral.
Measured: 6 weeks and 4 months postoperatively
s-FCA
Sagittal Femoral Component Alignment - Flexion/extension is measured on a lateral radiograph, relative to the posterior femoral cortex. 0° is considered neutral.
Measured: 6 weeks and 4 months postoperatively
RLL
Radiolucencies - Radiolucencies after UKR are divided into two types:
physiological and pathological. The former are < 2 mm thick, well defined, and accompanied by a parallel radiodense line, whereas the latter are > 2 mm thick, ill defined, and lacking accompanying radiodense lines. The pattern observed should be recorded as well as their location, which is divided into six zones on the AP view of the tibial component and six zones on the lateral view of the femoral component. Evaluation based on the zones of the Knee Society.
Measured: 6 weeks and 4 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start8 Dec 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medial GonarthrosisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Jan Yperman Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lenka Stroobant, Jan Yperman Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07677722
- Sponsor's protocol ID
- FiMO JYZ2025-10
- Acronym
- FiMo_UKP
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparative Study of Clinical Outcomes and Complications in Medial Knee Prostheses: Fixed Bearing Versus Mobile Bearing Design
- ClinicalTrials.gov ID
- NCT07677722
- Acronym / sponsor ID
- FiMo_UKP / FiMO JYZ2025-10
- Conditions
- Medial Gonarthrosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jan Yperman HospitalUniversity, hospital or other
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 1 Jul 2026 (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.
This prospective study aims to systematically compare the clinical and radiological outcomes and complications of mobile versus fixed unicompartimental knee prostheses.
Detailed description
In knee surgery, two dominant designs exist for the medial unicompartmental knee prosthesis (UKP): the fixed bearing (FB) and mobile bearing (MB) designs. The FB design is technically simpler to implant but has shown higher rates of early polyethylene wear in some studies. MB implants theoretically offer advantages in joint kinematics and load distribution but carry a risk of insert dislocation and periprosthetic fractures. An additional advantage of MB implants is the possibility of cementless implantation, potentially avoiding cement-related complications and reducing operative time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile UKP | – | –Mobile unicompartmental knee prosthesis |
| Fixed UKP | – | –Fixed unicompartmental knee prosthesis |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients eligible for a unicompartmental medial knee prosthesis based on the eligibility criteria.
Key inclusion criteria (5 listed)
- Age between 50 and 80 years
- Indication for medial UKP
- Intact anterior cruciate ligament
- Good bone quality based on imaging
- ASA score ≤ 3
Key exclusion criteria (7 listed)
- Inflammatory joint diseases
- Collateral ligament instability
- Simultaneous bilateral procedure
- BMI > 35
- History of fracture or osteotomy in the knee joint
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
OKS
Time frame: Preoperatively, 6 weeks, 4 months, 12 months, and 24 months postoperatively.
Oxford Knee Score
12 secondary outcomes
AMI
Time frame: Evaluate AMI (Arthrogenic Muscle Inhibition) preoperative, at 6 weeks and 4 months postoperative.
Surgery time
Time frame: Peroperatively
Complications
Time frame: Within 2 years postoperatively
Revision or reoperation
Time frame: Within 2 years postoperatively
c-FCA
Time frame: 6 weeks and 4 months postoperatively
EQ-5D-5L
Time frame: Preoperatively, 6 weeks, 4 months, 12 months, and 24 months postoperatively.
NRS
Time frame: Preoperatively, one week, 6 weeks, 4 months, 12 months, and 24 months postoperatively.]
KOOS-PS
Time frame: Preoperatively, 6 weeks, 4 months, 12 months, and 24 months postoperatively.
c-TCA
Time frame: 6 weeks and 4 months postoperatively
s-FCA
Time frame: 6 weeks and 4 months postoperatively
s-FCA
Time frame: 6 weeks and 4 months postoperatively
RLL
Time frame: 6 weeks and 4 months 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 1 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medial Gonarthrosis, run by Jan Yperman Hospital at 1 site in Belgium.
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 5 inclusion and 7 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 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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 Lenka Stroobant (+32496867115, lenka.stroobant@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OKS (time frame: Preoperatively, 6 weeks, 4 months, 12 months, and 24 months postoperatively.). 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 1 Jul 2026.