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Comparison of Knee Kinematics for Subjects Implanted With Either a ConforMIS or Traditional Knee Implant
NCT01717001 · View on ClinicalTrials.gov ↗
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
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2012-08 |
| Est. Completion | 2014-08 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01717001
The ClinicalTrials.gov registry entry for NCT01717001 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Restor3D, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Osteoarthritis appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01717001 reports 2 study locations spanning 1 distinct geographic area — top geographies include Tennessee. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT01717001?
This trial is sponsored by Restor3D, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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