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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04072055
Other study ID # P02.021.01
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date September 25, 2019
Est. completion date March 16, 2023

Study information

Verified date March 2023
Source Medacta International SA
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The prospective, multicentric, observational study has the aims to monitor the performance of the MOTO medial unicompartmental knee system in the treatment of patients with knee disease requiring a UKA. 150 patients will be recruited in 18 months and will be reviewed until 5 years follow-up visit after surgery. The primary objective of the study is to evaluate the prosthesis survival at 5 years.


Recruitment information / eligibility

Status Terminated
Enrollment 150
Est. completion date March 16, 2023
Est. primary completion date March 16, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with unicompartmental tibiofemoral osteoarthritis (OA) of the knee that meet the indications for use of Medacta implant included in this study (on-label use); - Patients suffering from unilateral osteoarthritis or osteonecrosis of a single knee compartment; - Frontal deformity < 10° (evaluated on weight-bearing long-axis x-rays); - Flexion contracture < 10°; - Intact ligaments; - Patients willing and able to provide written informed consent for participation in the study; - Patient's age over 18 years old; - Patient with BMI < 40 kg/m2; - Patients willing to comply with the pre and post-operative evaluation schedule. Exclusion Criteria: - Patients with one or more medical conditions identified as a contraindication in 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 a revision surgery; - Patients who had previously undergone high tibial osteotomy or anterior cruciate ligament (ACL) reconstruction; - Patients with BMI = 40 kg/m2; - Patients unable to understand and take action; - Any case not described in the inclusion criteria.

Study Design


Intervention

Device:
MOTO Medial
MOTO medial unicompartmental knee system

Locations

Country Name City State
Belgium AZ Zeno Campus Knokke-Heist Knokke-Heist
Belgium Clinique Saint-Joseph Liège

Sponsors (1)

Lead Sponsor Collaborator
Medacta International SA

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prosthesis survival survivorship analysis according to Kaplan-Meier method at 5 years after surgery 5 years
Secondary New Knee Society Score (KSS) Functionality and symptom of operated knee will be evaluated by New KSS score preoperative, 3 months, 1, 3 and 5 years
Secondary Radiological analysis Postoperative stability and fixation of the device will be assessed by standard radiological exams preoperative, postoperative, 3 months, 1, 3 and 5 years
Secondary Complication Intraoperative and postoperative complication will be collected during all duration of the study up to 5 years
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