Surgical RoboticsNAVIONCT03072459
A Retrospective Study of the Navio Robotic-assisted Surgical System
An observational study of Surgical Robotics and Knee Replacement, run by Smith & Nephew, Inc. at 5 sites in United States.
Trial summary
A retrospective, multi-center, cohort study with prospective follow-up and comparison to historical control Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Robotics, Knee Replacement
- How many people
- 128 participants
- Where
- 5 sitesUnited States
- Study dates
- 10 Jul 2017to 29 Nov 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: One hundred twenty-eight (128) subjects, including 10% inflation to allow for attrition
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Bronson Orthopedic Specialists
Battle Creek, Michigan, 49015
OrthoNeuro New Albany
New Albany, Ohio, 43054
Rothman Institute
Philadelphia, Pennsylvania, 19107
Hedley Orthopedics
Phoenix, Arizona, 85016
Santa Barbara Cottage Hospital
Santa Barbara, California, 93105
About this study
Official title: 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
Read the 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.
- Conditions
- Surgical Robotics, Knee Replacement
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the Navio™ System for Revisions at 2+ Years Post-surgical Implantation Survivorship
Analysis of the absence of device revision (overall survivorship) outcomes assessed from Baseline through 120 weeks post-surgical implantation.
Measured: Preoperative (Baseline) and 24, 48, 72, 96, and 120 weeks postoperatively
Secondary outcomes (9)
Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments
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.
Measured: Preoperative (Baseline) and 6, 12, 18, 24, 30, and 36 months postoperatively
Evaluation of Efficacy Based on Veterans RAND 12 (VR-12) Assessments
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.
Measured: Preoperative (Baseline) and 6, 12, 18, 24, 30, and 36 months postoperatively
Preoperative Evaluation of Efficacy Based on Radiographic Findings
Changes in radiographic findings (anterior-posterior [AP] and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.
Measured: Preoperative (Baseline)
Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings
Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.
Measured: 6 months postoperatively
Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings
Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.
Measured: 12 months postoperatively
Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings
Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.
Measured: 18 months postoperatively
Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings
Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.
Measured: 24 months postoperatively
Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings
Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.
Measured: 30 months postoperatively
Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings
Changes in radiographic findings (AP and lateral x-rays) from Baseline to 3 years postoperatively were collected for the SAF population.
Measured: 36 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study start10 Jul 2017
- Primary completion29 Nov 2017
- Study completion29 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Surgical RoboticsStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Beate Hanson, MD, PhD, Study director, Smith & Nephew, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03072459
- Sponsor's protocol ID
- 16-NPFS-11
- Acronym
- NAVIO
- Status last verified
- Dec 2021
- First submitted
- 2 Mar 2017
- Last updated
- 25 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study of the Navio™ Robotic-assisted Surgical System
- ClinicalTrials.gov ID
- NCT03072459
- Acronym / sponsor ID
- NAVIO / 16-NPFS-11
- Conditions
- Surgical Robotics, Knee Replacement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 29 Nov 2017 (actual)
- Study completion
- 29 Nov 2017 (actual)
- First posted
- 7 Mar 2017 (actual)
- Results
- Posted 2 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- One hundred twenty-eight (128) subjects, including 10% inflation to allow for attrition
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
9 secondary outcomes
Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments
Time frame: Preoperative (Baseline) and 6, 12, 18, 24, 30, and 36 months postoperatively
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
Preoperative Evaluation of Efficacy Based on Radiographic Findings
Time frame: Preoperative (Baseline)
Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings
Time frame: 6 months postoperatively
Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings
Time frame: 12 months postoperatively
Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings
Time frame: 18 months postoperatively
Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings
Time frame: 24 months postoperatively
Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings
Time frame: 30 months postoperatively
Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings
Time frame: 36 months postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beate Hanson, MD, PhD study director
Smith & Nephew, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Robotics and Knee Replacement, run by Smith & Nephew, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.