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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 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.

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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.

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

FieldValue
Enrollment Target 100 participants
Start Date 2014-02
Est. Completion 2015-01
Phase NA

Sponsor

MAKO Surgical

1 total trials

What the Registry Record Tells You About NCT02058069

The ClinicalTrials.gov registry entry for NCT02058069 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (98% lower). The listed sponsor is MAKO Surgical, which has 1 total studies on file at ClinicalTrials.gov.

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 3 study locations spanning 3 distinct geographic areas - top geographies include 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.

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