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Prospective Comparative Study of Clinical Outcomes and Complications in Medial Knee Prostheses: Fixed Bearing Versus Mobile Bearing Design

Prospective Comparative Study of Clinical Outcomes and Complications in Medial Knee Prostheses: Fixed Bearing Versus Mobile Bearing Design

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07677722
Acronym
FiMo_UKP
Enrollment
200
Registered
2026-07-01
Start date
2025-12-08
Completion date
2029-12-31
Last updated
2026-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medial Gonarthrosis

Brief summary

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.

Interventions

None listed

Sponsors

Jan Yperman Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
OKSPreoperatively, 6 weeks, 4 months, 12 months, and 24 months postoperatively.Oxford Knee Score

Secondary

MeasureTime frameDescription
AMIEvaluate AMI (Arthrogenic Muscle Inhibition) preoperative, at 6 weeks and 4 months postoperative.Arthrogenic Muscle Inhibition - DOI: 10.1002/ksa.12804 for grading
Surgery timePeroperativelyOperative time
ComplicationsWithin 2 years postoperativelyPostoperative complications
Revision or reoperationWithin 2 years postoperativelyRevision or reoperation
c-FCA6 weeks and 4 months postoperativelyCoronal 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.
EQ-5D-5LPreoperatively, 6 weeks, 4 months, 12 months, and 24 months postoperatively.The 5-level EQ-5D version.
NRSPreoperatively, one week, 6 weeks, 4 months, 12 months, and 24 months postoperatively.]Numeric Rating Scale
KOOS-PSPreoperatively, 6 weeks, 4 months, 12 months, and 24 months postoperatively.Knee Injury and Osteoarthritis Outcome Score-Physical function Short form
c-TCA6 weeks and 4 months postoperativelyCoronal 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.
s-FCA6 weeks and 4 months postoperativelySagittal 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.
RLL6 weeks and 4 months postoperativelyRadiolucencies - 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.

Countries

Belgium

Contacts

CONTACTLenka Stroobant
lenka.stroobant@ugent.be+32496867115

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 2, 2026