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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 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

200

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Belgien
    • Oost-Vlaanderen
      • Ieper, Oost-Vlaanderen, Belgien, 8900

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Jan Yperman Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

8. december 2025

Primær færdiggørelse (Anslået)

31. december 2029

Studieafslutning (Anslået)

31. december 2029

Datoer for studieregistrering

Først indsendt

11. juni 2026

Først indsendt, der opfyldte QC-kriterier

25. juni 2026

Først opslået (Faktiske)

1. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • FiMO JYZ2025-10

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Betingelser

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Placeringer

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