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A Retrospective Study of the Navio Robotic-assisted Surgical System (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
Results First Posted : May 2, 2022
Last Update Posted : May 25, 2022
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

Detailed Description:
Subjects who had previously received the Navio robotic-assisted surgical system for unilateral knee replacement (UKR) were assessed to determine the 2-year safety and effectiveness of the Navio system.

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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 : July 10, 2017
Actual Primary Completion Date : November 29, 2017
Actual Study Completion Date : November 29, 2017



Primary Outcome Measures :
  1. Evaluate the Navio™ System for Revisions at 2+ Years Post-surgical Implantation Survivorship [ Time Frame: Preoperative (Baseline) and 24, 48, 72, 96, and 120 weeks postoperatively ]
    Analysis of the absence of device revision (overall survivorship) outcomes assessed from Baseline through 120 weeks post-surgical implantation.


Secondary Outcome Measures :
  1. Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments [ Time Frame: Preoperative (Baseline) and 6, 12, 18, 24, 30, and 36 months postoperatively ]

    Analysis of KSS from preoperatively (Baseline) up to 36 months postoperatively in 6-months increments to evaluate objective observation, patient satisfaction, and function.

    Objective knee indicators: Range 0-100 points; Patient Satisfaction: Range 0-40 points; and Functional Activities: Range 0-100 points.

    Higher scores indicated a better outcome.


  2. Evaluation of Efficacy Based on Veterans RAND 12 (VR-12) Assessments [ Time Frame: Preoperative (Baseline) and 6, 12, 18, 24, 30, and 36 months postoperatively ]

    Analysis of VR-12 scores preoperatively (Baseline) through 36 months postoperatively in 6 months increments. These scores encompass the individual domains of physical component score (PCS), mental component score (MCS) as well as the sub-domain scores within the PCS (physical functioning, role physical, bodily pain, and general health) and those within the MCS (vitality, social functioning, role emotional, and mental health).

    Domain Scores:

    Physical Component Score (PCS): Range 1 to 20 Mental Component Score (MCS): Range 1 to 25

    Sub-domain Scores:

    Physical Functioning: Range 1 to 6 Role Physical: Range 1 to 4 Bodily Pain: Range 1 to 6 General Health: Range 1 to 6 Vitality: Range 1 to 6 Social Functioning: Range 1 to 6 Role Emotional: Range 1 to 4 Mental Health: Range 1 to 10

    Transformation of raw scale scores (range 0-100) = {(actual raw score - lowest possible raw score)/possible raw score range} x100

    A higher score indicates a better outcome.


  3. Preoperative Evaluation of Efficacy Based on Radiographic Findings [ Time Frame: Preoperative (Baseline) ]
    Changes in radiographic findings (anterior-posterior [AP] and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.

  4. Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings [ Time Frame: 6 months postoperatively ]
    Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.

  5. Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings [ Time Frame: 12 months postoperatively ]
    Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.

  6. Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings [ Time Frame: 18 months postoperatively ]
    Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.

  7. Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings [ Time Frame: 24 months postoperatively ]
    Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.

  8. Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings [ Time Frame: 30 months postoperatively ]
    Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.

  9. Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings [ Time Frame: 36 months postoperatively ]
    Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.



Information from the National Library of Medicine

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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
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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.
Investigators
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Study Director: Beate Hanson, MD, PhD Smith & Nephew, Inc.
  Study Documents (Full-Text)

Documents provided by Smith & Nephew, Inc.:
Study Protocol  [PDF] June 5, 2017
Statistical Analysis Plan  [PDF] January 29, 2018

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Responsible Party: Smith & Nephew, Inc.
ClinicalTrials.gov Identifier: NCT03072459    
Other Study ID Numbers: 16-NPFS-11
First Posted: March 7, 2017    Key Record Dates
Results First Posted: May 2, 2022
Last Update Posted: May 25, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No