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

25. juni 2026 oppdatert av: Lenka Stroobant, Jan Yperman Hospital

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

Studieoversikt

Status

Rekruttering

Forhold

Medial gonartrose

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

200

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Navn: Lenka Stroobant
Telefonnummer: +32496867115
E-post: lenka.stroobant@ugent.be

Studiesteder

Belgia
- Oost-Vlaanderen
  - Ieper, Oost-Vlaanderen, Belgia, 8900
    - Rekruttering
    - Orthopedic department
    - Ta kontakt med:
      
      Francois Hardeman, MD
      
      Telefonnummer: 057 35 73 70
      
      E-post: francois.hardeman@yperman.net

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Voksen
Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
Mobile UKP Mobile unicompartmental knee prosthesis
Fixed UKP Fixed unicompartmental knee prosthesis

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
OKS Tidsramme: Preoperatively, 6 weeks, 4 months, 12 months, and 24 months postoperatively.	Oxford Knee Score	Preoperatively, 6 weeks, 4 months, 12 months, and 24 months postoperatively.

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
AMI Tidsramme: Evaluate AMI (Arthrogenic Muscle Inhibition) preoperative, at 6 weeks and 4 months postoperative.	Arthrogenic Muscle Inhibition - DOI: 10.1002/ksa.12804 for grading	Evaluate AMI (Arthrogenic Muscle Inhibition) preoperative, at 6 weeks and 4 months postoperative.
Surgery time Tidsramme: Peroperatively	Operative time	Peroperatively
Complications Tidsramme: Within 2 years postoperatively	Postoperative complications	Within 2 years postoperatively
Revision or reoperation Tidsramme: Within 2 years postoperatively	Revision or reoperation	Within 2 years postoperatively
c-FCA Tidsramme: 6 weeks and 4 months postoperatively	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.	6 weeks and 4 months postoperatively
EQ-5D-5L Tidsramme: Preoperatively, 6 weeks, 4 months, 12 months, and 24 months postoperatively.	The 5-level EQ-5D version.	Preoperatively, 6 weeks, 4 months, 12 months, and 24 months postoperatively.
NRS Tidsramme: Preoperatively, one week, 6 weeks, 4 months, 12 months, and 24 months postoperatively.]	Numeric Rating Scale	Preoperatively, one week, 6 weeks, 4 months, 12 months, and 24 months postoperatively.]
KOOS-PS Tidsramme: Preoperatively, 6 weeks, 4 months, 12 months, and 24 months postoperatively.	Knee Injury and Osteoarthritis Outcome Score-Physical function Short form	Preoperatively, 6 weeks, 4 months, 12 months, and 24 months postoperatively.
c-TCA Tidsramme: 6 weeks and 4 months postoperatively	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.	6 weeks and 4 months postoperatively
s-FCA Tidsramme: 6 weeks and 4 months postoperatively	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.	6 weeks and 4 months postoperatively
s-FCA Tidsramme: 6 weeks and 4 months postoperatively	Sagittal Femoral Component Alignment - Flexion/extension is measured on a lateral radiograph, relative to the posterior femoral cortex. 0° is considered neutral.	6 weeks and 4 months postoperatively
RLL Tidsramme: 6 weeks and 4 months postoperatively	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.	6 weeks and 4 months postoperatively

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Jan Yperman Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

8. desember 2025

Primær fullføring (Antatt)

31. desember 2029

Studiet fullført (Antatt)

31. desember 2029

Datoer for studieregistrering

Først innsendt

11. juni 2026

Først innsendt som oppfylte QC-kriteriene

25. juni 2026

Først lagt ut (Faktiske)

1. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)