NCT03072459CompletedNot Applicable
A Retrospective Study of the Navio™ Robotic-assisted Surgical System
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Smith & Nephew, Inc.
- Enrollment
- 128
- Locations
- 5
- Primary Endpoint
- Evaluate the Navio™ System for Revisions at 2+ Years Post-surgical Implantation Survivorship
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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
- Evaluation of Efficacy Based on Veterans RAND 12 (VR-12) Assessments(Preoperative (Baseline) and 6, 12, 18, 24, 30, and 36 months postoperatively)
- Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings(24 months postoperatively)
- Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings(12 months postoperatively)
- Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings(18 months postoperatively)
- Preoperative Evaluation of Efficacy Based on Radiographic Findings(Preoperative (Baseline))
- Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings(6 months postoperatively)
- Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments(Preoperative (Baseline) and 6, 12, 18, 24, 30, and 36 months postoperatively)
- Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings(30 months postoperatively)
- Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings(36 months postoperatively)
Investigators
Study Sites (5)
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