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NCT02251522 · ClinicalTrials.gov registry record
A Single Time-Point Study to Evaluate the ConforMIS iTotal® (CR) Knee Versus Off-the-Shelf
A clinical trial of Osteoarthritis, sponsored by Restor3D.
- Completed
- Registry status
- 873
- Enrollment target
- 16
- Study locations
NCT02251522: Completed study of Osteoarthritis, sponsored by Restor3D.
NCT02251522 is a study of Osteoarthritis that has completed, run by Restor3D. The registered enrollment target is 873 participants, roughly in line with the 811-participant average among 135 other Osteoarthritis trials with a reported enrollment target. The trial reports 16 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02251522, a study of Osteoarthritis, has completed, sponsored by Restor3D.
- COMPLETED
- Registry status
- 873 participants
- Enrollment target
- 16
- Study locations
Study Summary
It has been noted that patients "dramatically overestimate their functional ability early after surgery." Despite use of assistive devices increasing and functional testing scores decreasing post-surgery, the patient reported outcome scores fail to show worsening. Outcome questionnaires will be administered and functional testing will be conducted on all patients to capture these changes.
Primary Outcome
The study primary endpoint is to compare functional testing time between patients implanted with the iTotal implant verses the off-the-shelf implants
Conditions Studied
Interventions
- DEVICE ConforMIS Total Knee Replacement System
- DEVICE Off-the-Shelf Knee Replacement System
Study Locations (16)
Other
- Vitos Orthopädische Klinik Kassel - Kassel
- MedArtes - Neutraubling
- Elblandkliniken Stiftung - Radebeul
- Sportklinik Stuttgart - Stuttgart
Florida
- Institute for Orthopaedic Surgery & Sports Medicine - Fort Myers
- Baptist Health South Florida - Miami
- Coastal Orthopaedic & Sports Medicine Ctr - Port Saint Lucie
Michigan
- Great Lakes Bone & Joint Center - Battle Creek
- Lederman-Kwartowitz Center for Orthopedics and Sports Medicine - West Bloomfield
Colorado
- Denver-Vail Orthopedics - Parker
Maryland
- Bethesda Orthopedic - Bethesda
Massachusetts
- Excel Orthopaedic Specialists - Woburn
Nevada
- Orthopaedic Institute of Henderson - Henderson
New York
- St. Lawrence Health System - Potsdam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 873 participants |
| Start Date | 2014-10 |
| Est. Completion | 2016-12 |
What the finished NCT02251522 record still lists
NCT02251522 is an observational study that tracks outcomes without assigning an intervention. The registered 873 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 811-participant average among 135 other Osteoarthritis trials with a reported enrollment target.
The record links to 1 condition, with Osteoarthritis appearing as the primary indexed condition, and to 2 interventions - of which ConforMIS Total Knee Replacement System is the first listed.
NCT02251522 lists 16 locations in 10 states (Other, Florida, Michigan).
Frequently Asked Questions
What is clinical trial NCT02251522 about?
NCT02251522 is a clinical study titled "A Single Time-Point Study to Evaluate the ConforMIS iTotal® (CR) Knee Versus Off-the-Shelf". It has been noted that patients "dramatically overestimate their functional ability early after surgery." Despite use of assistive devices increasing and functional testing scores decreasing post-surgery, the patient reported outcome scores fail to show worsening. Outcome questionnaires will be admi...
What is the current status of trial NCT02251522?
This trial is currently completed. The enrollment target is 873 participants. The study started on 2014-10. Estimated completion is 2016-12.
What conditions does trial NCT02251522 study?
This clinical trial studies the following conditions: Osteoarthritis.
What interventions are being tested in trial NCT02251522?
The interventions under investigation include: ConforMIS Total Knee Replacement System (DEVICE), Off-the-Shelf Knee Replacement System (DEVICE).
Who is sponsoring clinical trial NCT02251522?
This trial is sponsored by Restor3D, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02251522 being conducted?
This trial has 16 study locations across Colorado, Florida, Maryland, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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 NCT02251522's enrollment target sits among peer trials
873 17th of 135 higher than 119 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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