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NCT02494544 · ClinicalTrials.gov registry record · NA
A Multicenter Study to Evaluate Functional Outcome After Knee Replacement
A NA study, sponsored by Restor3D.
- Terminated
- Registry status
- NA
- Development phase
- 215
- Enrollment target
NCT02494544: Clinical Trial NA study, sponsored by Restor3D.
NCT02494544 is a NA study that was terminated before completion, run by Restor3D. The registered enrollment target is 215 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02494544, a NA study, was terminated before completion, sponsored by Restor3D.
- TERMINATED
- Registry status
- NA
- Development phase
- 215 participants
- Enrollment target
Study Summary
Patients will be consecutively enrolled by implant. Implant groups will be those who have undergone surgery with either a ConforMIS iTotal® CR TKA or an Off-the- Shelf (OTS) system. The patient will conduct functional testing and answer questionnaires. The results will compare the ConforMIS iTotal with an Off the Shelf Knee replacement.
Primary Outcome
Comparing the functional testing differences between iTotal and off the shelf. "Total Functional Activities Score" - a subscale within the Knee Society Score (KSS) with its individual subscale score. The Total Functional Activities Score subscale interprets the functional knee health of each patient via a series of tests such as walking/standing (30 points), standard activities (30 points), advanced activities (25 points), and sports/recreational activities (15 points). Deductions to score are m
Interventions
- DEVICE Off the Shelf Total Knee Replacement
- DEVICE ConforMIS iTotal Knee Replacement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 215 participants |
| Start Date | 2015-07-01 |
| Est. Completion | 2022-11-16 |
| Phase | NA |
Why NCT02494544 stopped before completion
NCT02494544 is an interventional study that assigns participants to a tested intervention. The registered 215 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Off the Shelf Total Knee Replacement is the first listed.
NCT02494544 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02494544 about?
NCT02494544 is a clinical study titled "A Multicenter Study to Evaluate Functional Outcome After Knee Replacement". Patients will be consecutively enrolled by implant. Implant groups will be those who have undergone surgery with either a ConforMIS iTotal® CR TKA or an Off-the- Shelf (OTS) system. The patient will conduct functional testing and answer questionnaires. The results will compare the ConforMIS iTotal...
What is the current status of trial NCT02494544?
This trial is currently terminated. It is a NA study. The enrollment target is 215 participants. The study started on 2015-07-01. Estimated completion is 2022-11-16.
What interventions are being tested in trial NCT02494544?
The interventions under investigation include: Off the Shelf Total Knee Replacement (DEVICE), ConforMIS iTotal Knee Replacement (DEVICE).
Who is sponsoring clinical trial NCT02494544?
This trial is sponsored by Restor3D, which has 20 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02494544's enrollment target sits among peer trials
215 487th of 2000 higher than 1,514 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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