A Retrospective Study of the Navio Robotic-assisted Surgical System (NAVIO)
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| ClinicalTrials.gov Identifier: NCT03072459 |
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Recruitment Status :
Completed
First Posted : March 7, 2017
Results First Posted : May 2, 2022
Last Update Posted : May 25, 2022
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| Condition or disease |
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| Surgical Robotics Knee Replacement |
| 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 |
- 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.
- 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.
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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 |
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.
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
| 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 | |
| Study Director: | Beate Hanson, MD, PhD | Smith & Nephew, Inc. |
Documents provided by Smith & Nephew, Inc.:
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |