Conventional vs. Robotic-Assisted Total Knee Arthroplasty: A Prospective, Randomized Trial of Clinical, Functional, and Radiographic Outcomes

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 85
Healthy Volunteers: t
View:

• 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

Locations
United States
New York
Columbia University Medical Center
RECRUITING
New York
Contact Information
Primary
Jacqueline Lenahan, BS
jl5092@cumc.columbia.edu
212-305-8193
Time Frame
Start Date: 2019-04-17
Estimated Completion Date: 2026-12
Participants
Target number of participants: 86
Treatments
No_intervention: Non robotics-assisted Surgical System
Conventional, non-robotics-assisted total knee surgical system
Experimental: Navio™ Robotics-assisted Surgical System
Navio™ Robotics-assisted Surgical System
Sponsors
Collaborators: Smith & Nephew, Inc.
Leads: Columbia University

This content was sourced from clinicaltrials.gov