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In Vivo Comparison of Knee Kinematics for Subjects Implanted With Either a ConforMIS or Traditional Knee Implant

NCT01882751 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 66

Last updated 2023-10-25

No results posted yet for this study

Summary

A better understanding of knee joint kinematics is important to explain the premature polyethylene wear failures within total knee arthroplasties (TKAs) and to help design a prosthesis that most closely approximates the normal knee. Previously, most experimental studies of knee kinematics have involved cadaveric, in vitro analyses, or have not tested the knee in a weight-bearing mode. Others have used exoskeletal linkages and skin markers that permit error due to undesired motions between markers and the underlying bone. More recently, fluoroscopy has been used to assess in vivo kinematics for subjects having a TKA.

ConforMIS has attempted to follow a clearly different path than the major orthopaedic companies. They have chosen to offer patients a personalized knee implant based off of each patient's femoral and tibial bone geometry. The hypothesis is that these subjects will experience a more normal-like kinematic pattern, eliminating paradoxical anterior sliding during weight-bearing knee flexion. Therefore, the objective for this study is to analyze the in vivo kinematics for 25 patients implanted with a personalized ConforMIS TKA and 25 patients implanted with a traditional TKA design to determine if there are any kinematic differences between these TKA designs.

Conditions

  • Complications; Arthroplasty

Interventions

DEVICE

Conformis CR Total Knee Replacement

iTotal CR by Conformis

DEVICE

Off the Shelf

A standard knee replacement not using ConforMIS' iFit technology

Sponsors & Collaborators

  • Restor3D

    lead INDUSTRY

Principal Investigators

  • Richard D Komistek, PhD · Univeristy of Tennessee

  • Harold Cates, MD · Tennessee Orthopaedic Clinics

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2017-07-31
Completion
2017-08-31
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 NCT01882751 on ClinicalTrials.gov