Actively Recruiting
Navio Robotic Versus Conventional Total Knee Arthroplasty
Led by Columbia University · Updated on 2025-09-08
86
Participants Needed
1
Research Sites
397 weeks
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
S
Smith & Nephew, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Total knee replacement surgery is a conventional approach to alleviating the pain and lack of function resulting from arthritis of the knee. While conventional knee replacement surgery is highly successful, incidences of improperly installed replacement parts are not uncommon. To improve outcomes, robotic-assisted total knee replacement surgery has recently become available, and has been shown to be extremely effective for partial knee replacement surgery. However, further research is needed to determine if this same technology can be equally effective for total knee replacement surgery. The present study will evaluate outcomes of robotic-assisted versus conventional total knee replacement surgery in patients between 40 and 85 years old with end stage arthritis of the knee. Other than surgical technique, patients will receive the same operative care and knee replacement implants. In addition to standard x-rays, subjects will be asked to complete several short-term clinical and functional tests and questionnaires to determine outcomes of their surgery.
CONDITIONS
Official Title
Navio Robotic Versus Conventional Total Knee Arthroplasty
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 40 and 85 years
- Body mass index (BMI) less than 40.0 kg/m^2
- End-stage knee osteoarthritis (Kellgren and Lawrence grade 4)
- Failure of at least 12 weeks of nonoperative treatment
- Ability to speak and understand English
You will not qualify if you...
- History of inflammatory arthritis in the same knee
- Previous open knee surgery on the same knee
- Prior osteotomy or fracture near the knee
- Knee deformity greater than 15 degrees from normal alignment
- Severe ligament instability on the inner or outer side of the knee
- Other musculoskeletal problems beyond one knee osteoarthritis that significantly limit function
- Unwillingness or inability to follow the study procedures and attend follow-up visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
Research Team
J
Jacqueline Lenahan, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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