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NCT01717001 · ClinicalTrials.gov registry record

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

A clinical trial of Osteoarthritis, sponsored by Restor3D.

Completed
Registry status
66
Enrollment target
2
Study locations

NCT01717001 is a study of Osteoarthritis that has completed, run by Restor3D. The registered enrollment target is 66 participants, below the 817-participant average among 135 other Osteoarthritis trials with a reported enrollment target (92% lower). The trial reports 2 study locations across 1 state.

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The verdict

NCT01717001, a study of Osteoarthritis, has completed, sponsored by Restor3D.

COMPLETED
Registry status
66 participants
Enrollment target
2
Study locations

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 Studied

Study Locations (2)

Tennessee

  • University of Tennessee - Knoxville
  • Tennessee Orthopedic Alliance - Nashville

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2012-08
Est. Completion 2014-08

Sponsor

Restor3D

20 total trials

What the Registry Record Tells You About NCT01717001

The ClinicalTrials.gov registry entry for NCT01717001 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 817-participant average among 135 other Osteoarthritis trials with a reported enrollment target (92% lower). The listed sponsor is Restor3D, which has 20 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Osteoarthritis appearing as the primary indexed condition, and to 0 interventions.

NCT01717001 reports 2 study locations spanning 1 distinct geographic area - top geographies include Tennessee.

Frequently Asked Questions

What is clinical trial NCT01717001 about?

NCT01717001 is a clinical study titled "Comparison of Knee Kinematics for Subjects Implanted With Either a ConforMIS or Traditional Knee Implant". 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 invol...

What is the current status of trial NCT01717001?

This trial is currently completed. The enrollment target is 66 participants. The study started on 2012-08. Estimated completion is 2014-08.

What conditions does trial NCT01717001 study?

This clinical trial studies the following conditions: Osteoarthritis.

Who is sponsoring clinical trial NCT01717001?

This trial is sponsored by Restor3D, which has 20 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01717001 being conducted?

This trial has 2 study locations across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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