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NCT02058069 · ClinicalTrials.gov registry record · NA
Robotic Arm Assisted Total Knee Arthroplasty
A NA study of Rheumatoid Arthritis and Osteoarthritis, sponsored by MAKO Surgical.
- Completed
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 3
- Study locations
NCT02058069: Completed NA study of Rheumatoid Arthritis and Osteoarthritis, sponsored by MAKO Surgical.
NCT02058069 is a NA study of Rheumatoid Arthritis and Osteoarthritis that has completed, run by MAKO Surgical. The registered enrollment target is 100 participants, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (98% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02058069, a NA study of Rheumatoid Arthritis and Osteoarthritis, has completed, sponsored by MAKO Surgical.
- COMPLETED
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 3
- Study locations
Study Summary
The Investigation will be conducted as a single-submission, multi-center study with approval from and in compliance of the Western Institutional Review Board (WIRB). The overall objective of this Investigation is to assess the safety and effectiveness of the Robotic Arm Interactive Orthopedic System (RIO) Total Knee Arthroplasty Application. Specifically, the study objectives are classified as follows: * Primary Objective: Surgeon assessment of standardized TKA complications both intra-operatively and at short term follow up. * Secondary Objective: Radiographic assessment of post-operative limb alignment. * Supporting Objective: Patient assessment of post-operative function and satisfaction.
Primary Outcome
Surgeon assessment of standardized TKA complications (Healey et al. CORR 2012) both intra-operatively and at short term follow up. The nine complications relating to soft tissue damage for primary TKA that were assessed as part of this study were as follows: Blood loss, Vascular injury, MCL injury, Periprosthetic fracture, Extensor mechanism disruption, Patellofemoral dislocation, Tibiofemoral dislocation, Neurological impairment, Instability.
Conditions Studied
Interventions
- DEVICE Robotic Arm Assisted Total Knee Arthroplasty
Study Locations (3)
California
- Coon Joint Replacement Institue; St. Helena Hospital - St. Helena
Florida
- Florida Orthopedic Institute - Tampa
Texas
- Memorial Bone and Joint Research Foundation; Memorial Hermann Memorial City Medical Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2014-02 |
| Est. Completion | 2015-01 |
| Phase | NA |
What the finished NCT02058069 record still lists
NCT02058069 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (98% lower).
The record links to 3 conditions, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 1 intervention - of which Robotic Arm Assisted Total Knee Arthroplasty is the first listed.
NCT02058069 reports a single indexed study location in California, Florida, Texas.
Frequently Asked Questions
What is clinical trial NCT02058069 about?
NCT02058069 is a clinical study titled "Robotic Arm Assisted Total Knee Arthroplasty". The Investigation will be conducted as a single-submission, multi-center study with approval from and in compliance of the Western Institutional Review Board (WIRB). The overall objective of this Investigation is to assess the safety and effectiveness of the Robotic Arm Interactive Orthopedic Syste...
What is the current status of trial NCT02058069?
This trial is currently completed. It is a NA study. The enrollment target is 100 participants. The study started on 2014-02. Estimated completion is 2015-01.
What conditions does trial NCT02058069 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis, Osteoarthritis, Post Traumatic Arthritis.
What interventions are being tested in trial NCT02058069?
The interventions under investigation include: Robotic Arm Assisted Total Knee Arthroplasty (DEVICE).
Who is sponsoring clinical trial NCT02058069?
This trial is sponsored by MAKO Surgical, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02058069 being conducted?
This trial has 3 study locations across California, Florida, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02058069's enrollment target sits among peer trials
100 117th of 197 higher than 78 of 197 other Rheumatoid Arthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rheumatoid Arthritis 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.
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