N/A
Completed N=122
Navio With Total Knee Arthroplasty
Total Knee Arthroplasty · Arthroplasty of Knee
Source: ClinicalTrials.gov NCT03317834 ↗
Enrolled (actual)
122
Serious AEs
21.3%
Results posted
Oct 2024
Primary outcomePrimary: Count of Participants With Post-operative Mechanical Alignment — 106; 9 Participants
Summary
The purpose of this study is to demonstrate superior accuracy with the Navio ™ Robotic-assisted Surgical System in achieving desired post-operative mechanical alignment, compared to TKA procedures using standard instruments. An additional study purpose is to document clinical and patient-reported outcomes in subjects receiving TKA with the Navio ™ system.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Count of Participants With Post-operative Mechanical Alignment |
106; 9 | — |
| SECONDARY Count of Participants With Implant Survival |
117; 5 | — |
| SECONDARY Knee Society Score 2011 |
14.21; 8.42; 9.78; 9.39; 9.97; 42.13 | — |
| SECONDARY Quality of Life EQ-5D-5L |
73.44; 75.01; 78.44; 81.82; 84.18 | — |
| SECONDARY Forgotten Joint Score (FJS) |
11.84; 17.31; 51.45; 66.31; 78.56 | — |
| SECONDARY Hospital Length of Stay |
2.04 | — |
| SECONDARY Operative Time |
90.48 | — |
| SECONDARY Radiographic Assessment - Anteroposterior (AP) Angle |
65.39; 71.77; 70.10; 73.41; 72.89; 62.34 | — |
| SECONDARY Radiographic Assessment - Lateral Angle |
6.12; 2.68; 2.41; 3.10; 3.31; 80.18 | — |
| SECONDARY Radiographic Assessment - Count of Participant Displacements |
62; 24 | — |
| SECONDARY Radiographic Assessment - Displacement Measurement |
3.95 | — |
Eligibility Criteria
Inclusion Criteria
- Subject requires primary total knee arthroplasty with the Journey II BCS or Cruciate-Retraining (CR) Systems due to degenerative joint disease (primary diagnosis of osteoarthritis, post-traumatic arthritis, avascular necrosis, rheumatoid arthritis.
- Subject was considered skeletally mature at the time of cone implantation (at least 18 years or older.)
- Subject agrees to consent to and to follow the study visit schedule (as defined in the study protocol and informed consent form) by signing the IRB/EC approved informed consent form.
- Subject plans to be available through two (2) years postoperative follow-up.
Exclusion Criteria
- Subject has BMI ≥ 40.
- Subject has condition(s) that may interfere with the TKA survival or outcome (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease, or an active, local infection).
- Subject is deemed by investigator to require a constrained or deep dish tibial insert.
- Subject has inadequate bone stock to support the device (severe osteopenia, history of severe osteoporosis or severe osteopenia).
- Subject has mental or neurologic condition(s) that may pre-empt the ability or willingness to restrict activities.
- Subject is 80 years of age or older.
- Subject is a prisoner or impending incarceration.
Data sourced from ClinicalTrials.gov (NCT03317834). 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. Informational only — not medical advice.