Clinical trial NCT03522025: GMK-UNI Anatomical UKA: Fixation of Cemented Vs Cementless Designs
Official title: A Prospective, Multicenter, Randomised Study to Evaluate the Fixation of Cemented and Cementless Design of GMK-UNI Anatomical Knee Prosthesis.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: Medacta International SA
Sponsor class: INDUSTRY
First posted: 2018-05-11
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed description: The Primary objective is to compare the quality of fixation of cemented and cementless designs of GMK-UNI unicompartmental knee replacement at 2 years of follow-up.

The Secondary objectives include the evaluation of the patient improvement (subjective and objective) using the new Knee Society Score (KSS); the patient's anterior pain following UKA and any eventual patella-femoral disorder; Implant survival rate using the Kaplan Meier analysis; Post-op radiological findings and Adverse Events.

The Primary outcome aims to compare the occurrence of radiolucency's lines (both partial and complete) between the two study groups. Secondary outcomes include New KSS, OKS, Kaplan Meier analysis and stability and fixation of UNI prosthesis.

All patients who meet the inclusion criteria to take part in the current clinical study will be invited to participate before the surgery.

Subjects will be randomized during the screening; half of them will receive the cemented GMK-UNI anatomical UKA and the other half the cementless GMK-UNI anatomical UKA.

Clinical data will be recorded on CRF at those time-points:

* Before the surgery
* During the surgery
* After the surgery at 3 months, 1, 2, 3 and 5 years.

Eligibility criteria: 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 outcomes:
measure: Comparing the occurrence of radiolucency's lines
timeFrame: 5 yrs
Secondary outcomes:
measure: Anterior Knee Pian Scale (Kujala score)
timeFrame: pre-op; 3months;1,2,3,5 yrs
measure: Implant survival rate using Kaplan Meier analysis
timeFrame: 5 yrs
measure: Recording of adverse events
timeFrame: Throughout the study
measure: Oxford Knee Score
timeFrame: Pre-op;3month;1,2,3,5yrs
measure: New Knee Society Score
timeFrame: Pre-op:3months;1,2,3,5 yrs
measure: Stability and fixation of unicompartmental prosthesis
timeFrame: 5 yrs
Other outcomes:
Locations:
city: Bourgoin-Jallieu
country: France
facility: Clinique Saint Vincent de Paul
city: La Rochelle
country: France
facility: Clinique du Mail
city: Saint Etienne
country: France
facility: Centre Orthéo, Espace Fauriel
city: Saint-Grégoire
country: France
facility: CHP Saint-Grégoire
city: Solothurn
country: Switzerland
facility: Dr. Näder Helmy
Study officials:
References: