We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.

Tracking Information
First Submitted Date March 2, 2017
First Posted Date March 7, 2017
Results First Submitted Date July 1, 2019
Results First Posted Date May 2, 2022
Last Update Posted Date May 25, 2022
Actual Study Start Date July 10, 2017
Actual Primary Completion Date November 29, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 28, 2022)
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.
Original Primary Outcome Measures
 (submitted: March 2, 2017)
revision rate at two years [ Time Frame: 2 years ]
revision of knee replacement
Change History
Current Secondary Outcome Measures
 (submitted: February 28, 2022)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Retrospective Study of the Navio Robotic-assisted Surgical System
Official Title A Retrospective Study of the Navio™ Robotic-assisted Surgical System
Brief Summary A retrospective, multi-center, cohort study with prospective follow-up and comparison to historical control
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population One hundred twenty-eight (128) subjects, including 10% inflation to allow for attrition
Condition
  • Surgical Robotics
  • Knee Replacement
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 2, 2017)
128
Original Estimated Enrollment Same as current
Actual Study Completion Date November 29, 2017
Actual Primary Completion Date November 29, 2017   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03072459
Other Study ID Numbers 16-NPFS-11
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Smith & Nephew, Inc.
Original Responsible Party Same as current
Current Study Sponsor Smith & Nephew, Inc.
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: Beate Hanson, MD, PhD Smith & Nephew, Inc.
PRS Account Smith & Nephew, Inc.
Verification Date December 2021