Navio Robotic Versus Conventional Total Knee Arthroplasty
Recruiting · NCT03519269 · Interventional (participants receive a specific treatment) · Lead sponsor: Columbia University
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- age between 40 and 85
- body mass index (BMI) less than 40.0 kg/m\^2
- end-stage knee osteoarthritis (Kellgren and Lawrence grade 4)
- failure of a minimum 12 weeks of nonoperative management
- English fluency
Exclusion criteria
- history of inflammatory arthropathy in the same knee
- history of prior open knee surgery in the same knee
- history of prior osteotomy or periarticular fracture
- deformity \> 15 degrees from a neutral mechanical axis
- gross ligamentous incompetence of the medial or lateral collateral ligaments
- musculoskeletal involvement beyond unilateral knee osteoarthritis significantly limiting their function
- unwillingness or inability to participate in the proposed study protocol and follow-up
Where it is running
1 location listed across 1 US state.
- Columbia University Medical Center - New York, New York, United States