A Retrospective Study of the Navio Robotic-assisted Surgical System
Completed
Conditions studied: Surgical Robotics, Knee Replacement
In brief
A retrospective, multi-center, cohort study with prospective follow-up and comparison to historical control
Key facts
- Study ID
- NCT03072459
- Run by
- Smith & Nephew, Inc.
- People needed
- 128
- Starts
- 2017-07-10
- Expected to finish
- 2017-11-29
- Last updated by the study team
- 2022-05-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Hedley Orthopedics — Phoenix, Arizona, United States
- Santa Barbara Cottage Hospital — Santa Barbara, California, United States
- Bronson Orthopedic Specialists — Battle Creek, Michigan, United States
- OrthoNeuro New Albany — New Albany, Ohio, United States
- Rothman Institute — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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