MOTO Post-marketing Surveillance Study

Osteo Arthritis Knee Clinical Trial

Official title:

MOTO MEDIAL UNICOMPARTMENTAL KNEE ARTHROPLASTY: OPEN, PROSPECTIVE, MULTICENTRIC, OBSERVATIONAL STUDY

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04072055
• Other study ID #: P02.021.01
• Status: Terminated
• 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
• 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.

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee
• Osteonecrosis

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