MOTO Post-marketing Surveillance Study

March 16, 2023 updated by: Medacta International SA

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Knokke-Heist, Belgium, 8300
        • AZ Zeno Campus Knokke-Heist
      • Liège, Belgium, 4000
        • Clinique Saint-Joseph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

150 patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MOTO medial
Patients suitable fulfilling the standard criteria for the implantation of unicondylar implant.
Device: MOTO Medial
MOTO medial unicompartmental knee system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prosthesis survival
Time Frame: 5 years
survivorship analysis according to Kaplan-Meier method at 5 years after surgery
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
New Knee Society Score (KSS)
Time Frame: preoperative, 3 months, 1, 3 and 5 years
Functionality and symptom of operated knee will be evaluated by New KSS score
preoperative, 3 months, 1, 3 and 5 years
Radiological analysis
Time Frame: preoperative, postoperative, 3 months, 1, 3 and 5 years
Postoperative stability and fixation of the device will be assessed by standard radiological exams
preoperative, postoperative, 3 months, 1, 3 and 5 years
Complication
Time Frame: up to 5 years
Intraoperative and postoperative complication will be collected during all duration of the study
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medacta International SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2019

Primary Completion (Actual)

March 16, 2023

Study Completion (Actual)

March 16, 2023

Study Registration Dates

First Submitted

August 26, 2019

First Submitted That Met QC Criteria

August 26, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Actual)

March 20, 2023

Last Update Submitted That Met QC Criteria

March 16, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P02.021.01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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