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NCT01882751 · ClinicalTrials.gov registry record
In Vivo Comparison of Knee Kinematics for Subjects Implanted With Either a ConforMIS or Traditional Knee Implant
A clinical trial, sponsored by Restor3D.
- Completed
- Registry status
- 66
- Enrollment target
NCT01882751 is a clinical trial that has completed, run by Restor3D. The registered enrollment target is 66 participants.
The verdict
NCT01882751 has completed, sponsored by Restor3D.
- COMPLETED
- Registry status
- 66 participants
- Enrollment target
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.
Interventions
- DEVICE Conformis CR Total Knee Replacement
- DEVICE Off the Shelf
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2013-06 |
| Est. Completion | 2017-08 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01882751
The ClinicalTrials.gov registry entry for NCT01882751 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. The listed sponsor is Restor3D, which has 20 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Conformis CR Total Knee Replacement is the first listed.
NCT01882751 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01882751 about?
NCT01882751 is a clinical study titled "In Vivo 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 NCT01882751?
This trial is currently completed. The enrollment target is 66 participants. The study started on 2013-06. Estimated completion is 2017-08.
What interventions are being tested in trial NCT01882751?
The interventions under investigation include: Conformis CR Total Knee Replacement (DEVICE), Off the Shelf (DEVICE).
Who is sponsoring clinical trial NCT01882751?
This trial is sponsored by Restor3D, which has 20 total clinical trials registered on ClinicalTrials.gov.
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