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NCT03354195 · ClinicalTrials.gov registry record · NA
MAKO-Uni-Knee Arthroplasty Clinical Outcomes and Function
A NA study of Clinical Outcomes, sponsored by Foundation for Orthopaedic Research and Education.
- Completed
- Registry status
- NA
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT03354195: Completed NA study of Clinical Outcomes, sponsored by Foundation for Orthopaedic Research and Education.
NCT03354195 is a NA study of Clinical Outcomes that has completed, run by Foundation for Orthopaedic Research and Education. The registered enrollment target is 14 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03354195, a NA study of Clinical Outcomes, has completed, sponsored by Foundation for Orthopaedic Research and Education.
- COMPLETED
- Registry status
- NA
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study Summary
This study represents a single-surgeon/institution, non-randomized, consecutive series, prospective and comparative cohort design. The Principal Investigator is anticipating 100 study patients in the INTACT group and 35 patients in the Anterior Cruciate Ligament-Deficient group.The schedule of events lists the imaging procedures and questionnaires to be completed at each visit. Subjects will be consented and enrolled within 28 days prior to surgery and participate in follow-up visits for two years following their Unicompartmental Knee Arthroplasty. A 3-year enrollment duration is anticipated to enroll a minimum and consecutive series of 25 patients in the experimental Anterior Cruciate Ligament-deficient group. Over the same enrollment duration, 100+ patients with intact Anterior Cruciate Ligaments are expected to be in the control group and undergo Unicompartmental Knee Arthroplasty. The enrollment duration (3 years) and total study duration (5 years) are based on patient volume estimates provided by the Principal Investigator.
Primary Outcome
Knee Society Score (KSS) and Knee Injury and Osteoarthritis Outcome Score (KOOS)
Conditions Studied
Interventions
- PROCEDURE Unicompartmental knee arthroplasty with the Mako Robotic Arm-assisted system.
Study Locations (1)
Florida
- Florida Orthopaedic Institute - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2018-07-01 |
| Est. Completion | 2020-01-30 |
| Phase | NA |
What the finished NCT03354195 record still lists
NCT03354195 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Clinical Outcomes appearing as the primary indexed condition, and to 1 intervention - of which Unicompartmental knee arthroplasty with the Mako Robotic Arm-assisted system. is the first listed.
NCT03354195 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT03354195 about?
NCT03354195 is a clinical study titled "MAKO-Uni-Knee Arthroplasty Clinical Outcomes and Function". This study represents a single-surgeon/institution, non-randomized, consecutive series, prospective and comparative cohort design. The Principal Investigator is anticipating 100 study patients in the INTACT group and 35 patients in the Anterior Cruciate Ligament-Deficient group.The schedule of event...
What is the current status of trial NCT03354195?
This trial is currently completed. It is a NA study. The enrollment target is 14 participants. The study started on 2018-07-01. Estimated completion is 2020-01-30.
What conditions does trial NCT03354195 study?
This clinical trial studies the following conditions: Clinical Outcomes.
What interventions are being tested in trial NCT03354195?
The interventions under investigation include: Unicompartmental knee arthroplasty with the Mako Robotic Arm-assisted system. (PROCEDURE).
Who is sponsoring clinical trial NCT03354195?
This trial is sponsored by Foundation for Orthopaedic Research and Education, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03354195 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03354195's enrollment target sits among peer trials
14 1909th of 2000 higher than 90 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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