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Persona TKA With iASSIST Knee System and iASSIST Knee System

NCT03227692 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2020-07-02

Study results available
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Summary

The purpose of this study is to compare the accuracy of knee component alignment between patients operated with iASSIST Knee (Investigational group) versus patients operated without iASSIST Knee (Control group) using the same implant system.

Conditions

  • Osteoarthritis, Knee

Interventions

DEVICE

Persona Knee System

Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.

PROCEDURE

Total Knee Arthroplasty

Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.

DEVICE

iAssist Knee

Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • Toshihiro Ohdera, M.D. · Fukuoka Orthopaedic Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-18
Primary Completion
2019-11-14
Completion
2019-12-02
FDA Device
Yes

Countries

  • Japan

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 NCT03227692 on ClinicalTrials.gov