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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 uppdaterad 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.

Studieöversikt

Status

Rekrytering

Betingelser

Medial gonartros

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

200

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

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

Studieorter

Belgien
- Oost-Vlaanderen
  - Ieper, Oost-Vlaanderen, Belgien, 8900
    - Rekrytering
    - Orthopedic department
    - Kontakt:
      
      Francois Hardeman, MD
      
      Telefonnummer: 057 35 73 70
      
      E-post: francois.hardeman@yperman.net

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

Vuxen
Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Antal grupper/kohorter

Kohorter och interventioner

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

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
OKS Tidsram: 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.

Sekundära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
AMI Tidsram: 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 Tidsram: Peroperatively	Operative time	Peroperatively
Complications Tidsram: Within 2 years postoperatively	Postoperative complications	Within 2 years postoperatively
Revision or reoperation Tidsram: Within 2 years postoperatively	Revision or reoperation	Within 2 years postoperatively
c-FCA Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Jan Yperman Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

8 december 2025

Primärt slutförande (Beräknad)

31 december 2029

Avslutad studie (Beräknad)

31 december 2029

Studieregistreringsdatum

Först inskickad

11 juni 2026

Först inskickad som uppfyllde QC-kriterierna

25 juni 2026

Första postat (Faktisk)

1 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)