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A Study to Evaluate the Conformis iTotal Identity Knee Replacement System

NCT04667559 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 22

Last updated 2023-10-25

No results posted yet for this study

Summary

This is a prospective multicenter study located in the United States. Subjects will be implanted with an iTotal Identity Knee Replacement System and followed for 10 years post implantation.

Conditions

  • Osteoarthritis, Knee

Interventions

DEVICE

Conformis iTotal Identity Knee Replacement System

The iTotal® Identity KRS is a tri-compartmental semi-constrained knee prosthesis composed of three components: a Femoral Component, a Tibial Component, and a Patellar Component.Using patient imaging, a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The treatment allows for the placement of a cemented metallic device designed from the patient's natural bone geometry. This process allows definition of the shape and size of the femoral and tibial components of the implant, as well as the disposable instrumentation.

Sponsors & Collaborators

  • Restor3D

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-12
Primary Completion
2022-12-14
Completion
2022-12-14
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04667559 on ClinicalTrials.gov