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Completed

NCT Number: NCT03072459

A Retrospective Study of the Navio Robotic-assisted Surgical System

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

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Key information

Conditions

Surgical Robotics Knee Replacement

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hedley Orthopedics, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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

  • Subject received the Navio System-assisted UKR on the index joint as a revision for a previously failed UKR.
  • 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).
  • Subject, in the opinion of the Investigator, had a neuromuscular disorder that prohibited control of the index joint.
  • Subject, in the opinion of the Investigator, was morbidly obese.
  • Subject, in the opinion of the Investigator, was contraindicated for UKR.
  • 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.
  • Subject (prospective subjects only) is a prisoner.

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Smith & Nephew, Inc.

Industry

Registry information

Official study title

A Retrospective Study of the Navio™ Robotic-assisted Surgical System

Acronym: NAVIO

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 7, 2017
Registry last updated
May 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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