Status:
TERMINATED
MOTO Post-marketing Surveillance Study
Lead Sponsor:
Medacta International SA
Conditions:
Osteonecrosis
Osteo Arthritis Knee
Eligibility:
All Genders
18+ years
Brief 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 UK...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 25 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 16 2023
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04072055
Start Date
September 25 2019
End Date
March 16 2023
Last Update
March 20 2023
Active Locations (2)
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1
AZ Zeno Campus Knokke-Heist
Knokke-Heist, Belgium, 8300
2
Clinique Saint-Joseph
Liège, Belgium, 4000