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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: Completed study of Osteoarthritis, sponsored by Restor3D.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Comparison of amount of flexion achieved by the knee between the two arms

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
Restor3D

20 total trials

What the finished NCT01717001 record still lists

NCT01717001 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 817-participant average among 135 other Osteoarthritis trials with a reported enrollment target (92% lower).

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

NCT01717001 reports a single indexed study location in 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.

Similar trials for Osteoarthritis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01717001's enrollment target sits among peer trials

66 107th of 135 higher than 29 of 135 other Osteoarthritis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Osteoarthritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01717001, the US trial registry maintained by the National Library of Medicine. NCT01717001 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.