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Robotic Arm Assisted Total Knee Arthroplasty

NCT02058069 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2017-04-18

Study results available
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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.

Conditions

Interventions

DEVICE

Robotic Arm Assisted Total Knee Arthroplasty

The total knee implant system used for this study was the Kinetis implant system (MAKO Surgical Corp.).

Sponsors & Collaborators

  • MAKO Surgical Corp.

    lead INDUSTRY

Principal Investigators

  • Kenneth Gustke, MD · Florida Orthopedic Institute, Tampa General Hospital

  • Thomas Coon, MD · Coon Joint Replacement Institute, St. Helena Hospital

  • Stefan Kreuzer, MD · Memorial Bone and Joint Research Foundation, Memorial Hermann Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02058069 on ClinicalTrials.gov