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Clinical Trials in France / NCT03522025
Active, not recruiting Not applicable

GMK-UNI Anatomical UKA: Fixation of Cemented vs Cementless Designs

NCT03522025 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2019-02-15
Last updated
2025-09-25

Condition(s) studied

Osteoarthritis, Knee

Investigational drug(s) / intervention(s)

Unicompartmental Knee Arthroplasty (UKA)

Unicompartmental Knee Arthroplasty (UKA): Unicompartmental Knee Arthroplasty (UKA) is a less invasive treatment option compared to Total Knee Arthroplasty (TKA) for patients with primary anteromedial knee osteoarthritis.

Study summary

Unicompartmental knee arthroplasty (UKA) is the principal surgical alternative to the total knee arthroplasty (TKA) in patients with end-stage unicompartmental tibiofemoral osteoarthritis (OA) of the knee. The current comparative randomized study aims to evaluate the fixation of cemented and cementless designs of GMK-UNI unicompartmental knee prosthesis over a 5-year time period.

Eligibility

Sex
ALL
Min age
18 Years
Max age
95 Years
Healthy volunteers
No
Inclusion criteria: * Patients with end-stage unicompartmental tibiofemoral osteoarthritis (OA) of the knee that meet the indications for use according to Medacta implants included in this study (on-label use); * Those suffering from unilateral osteoarthritis or osteonecrosis of the medial compartment; * Frontal deformity \< 10° (evaluated on weight-bearing long-axis x-rays); * Flexion contracture \< 10°; * Intact ligaments; * Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery; * Patient's age over 18 years old; * Patient with BMI \< 40 kg/m2; * Patients must be willing to comply with the pre and post-operative evaluation schedule. Exclusion criteria: * Patients with one or more medical conditions identified as a contraindication defined by the labelling on any Medacta implants used in this study; * Any patient who cannot or will not provide informed consent for participation in the study; * Patients who need to undergo lateral unicompartmental knee arthroplasty; * Patients who need a revision surgery; * Patients who need a patella-femoral joint prosthesis; * Patients who had previously undergone high tibial osteotomy or ACL reconstruction; * Patients with BMI ≥ 40 kg/m2; * Patients unable to understand and take action; * Any case not described in the inclusion criteria; * Patients aged under 18 years;

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Clinique Saint Vincent de Paul Bourgoin France
Clinique du Mail La Rochelle France
Centre Orthéo, Espace Fauriel Saint-Etienne France
CHP Saint-Grégoire Saint-Grégoire France
Dr. Näder Helmy Solothurn Switzerland

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03522025 on ClinicalTrials.gov ↗ ← All trials in France