Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Retrospective Study of the Navio (NAVIO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03072459
Recruitment Status : Completed
First Posted : March 7, 2017
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc.

Brief Summary:
A retrospective, multi-center, cohort study with prospective follow-up and comparison to historical control

Condition or disease
Surgical Robotics Knee Replacement

Layout table for study information
Study Type : Observational
Actual Enrollment : 128 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: A Retrospective Study of the Navio◊ Robotic-assisted Surgical System
Actual Study Start Date : February 20, 2017
Actual Primary Completion Date : October 15, 2017
Actual Study Completion Date : March 31, 2018



Primary Outcome Measures :
  1. revision rate at two years [ Time Frame: 2 years ]
    revision of knee replacement



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
One hundred twenty-eight (128) subjects, including 10% inflation to allow for attrition
Criteria

Inclusion Criteria:

  1. Male or female subjects ≥ 18 years old (at the time of surgery) who have undergone Navio System-assisted UKR at least 2 years prior to enrollment. This includes UKR procedures with all Unicondylar Knee cemented implant designs.
  2. Subject had a primary diagnosis of unicompartmental, non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis, required correction of functional deformity, or required treatment of fractures that were unmanageable using other techniques.

Exclusion Criteria:

  1. Subject received the Navio System-assisted UKR on the index joint as a revision for a previously failed UKR.
  2. Subject, in the opinion of the Investigator, had advanced osteoarthritis or joint disease at the time of surgery and was better suited for Total Knee Arthroplasty (TKA).
  3. Subject, in the opinion of the Investigator, had a neuromuscular disorder that prohibited control of the index joint.
  4. Subject, in the opinion of the Investigator, was morbidly obese.
  5. Subject, in the opinion of the Investigator, was contraindicated for UKR.
  6. Subject (prospective subjects only), in the opinion of the Investigator, has an emotional or neurological condition including mental illness, mental retardation, drug or alcohol abuse.
  7. Subject (prospective subjects only) is a prisoner.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03072459


Locations
Layout table for location information
United States, Arizona
Hedley Orthopedics
Phoenix, Arizona, United States, 85016
United States, California
Santa Barbara Cottage Hospital
Santa Barbara, California, United States, 93105
United States, Michigan
Bronson Orthopedic Specialists
Battle Creek, Michigan, United States, 49015
United States, Ohio
OrthoNeuro New Albany
New Albany, Ohio, United States, 43054
United States, Pennsylvania
Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Smith & Nephew, Inc.
Layout table for additonal information
Responsible Party: Smith & Nephew, Inc.
ClinicalTrials.gov Identifier: NCT03072459    
Other Study ID Numbers: 16-NPFS-11
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No