N/A
N=128
A Retrospective Study of the Navio Robotic-assisted Surgical System
Surgical Robotics · Knee Replacement
Bottom Line
View on ClinicalTrials.gov: NCT03072459 ↗Enrolled (actual)
128
Serious AEs
1.6%
Results posted
May 2022
Primary outcome: Primary: Evaluate the Navio™ System for Revisions at 2+ Years Post-surgical Implantation Survivorship — 0; 0; 1; 0 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Smith & Nephew, Inc.
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluate the Navio™ System for Revisions at 2+ Years Post-surgical Implantation Survivorship |
0; 0; 1; 0; 0; 0 | — |
| SECONDARY Evaluation of Efficacy Based on Knee Society Score (KSS) Assessments |
48.6; 51.6; 49.3; 49.9; 61.9; 63.8 | — |
| SECONDARY Evaluation of Efficacy Based on Veterans RAND 12 (VR-12) Assessments |
11.2; 15.0; 15.0; 14.9; 14.6; 15.0 | — |
| SECONDARY Preoperative Evaluation of Efficacy Based on Radiographic Findings |
0; 0; 0; 128; 0; 0 | — |
| SECONDARY Postoperative 6-Month Evaluation of Efficacy Based on Radiographic Findings |
0; 25; 3; 99; 0; 25 | — |
| SECONDARY Postoperative 12-Month Evaluation of Efficacy Based on Radiographic Findings |
1; 24; 3; 30; 0; 25 | — |
| SECONDARY Postoperative 18-Month Evaluation of Efficacy Based on Radiographic Findings |
0; 27; 0; 14; 1; 26 | — |
| SECONDARY Postoperative 24-Month Evaluation of Efficacy Based on Radiographic Findings |
1; 22; 5; 33; 0; 24 | — |
| SECONDARY Postoperative 30-Month Evaluation of Efficacy Based on Radiographic Findings |
0; 29; 1; 26; 0; 29 | — |
| SECONDARY Postoperative 36-Month Evaluation of Efficacy Based on Radiographic Findings |
0; 13; 0; 10; 0; 13 | — |
Summary
A retrospective, multi-center, cohort study with prospective follow-up and comparison to historical control
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03072459). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.