RECRUITING

Navio Robotic Versus Conventional Total Knee Arthroplasty

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-04-17
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03519269

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * age between 40 and 85
  2. * body mass index (BMI) less than 40.0 kg/m\^2
  3. * end-stage knee osteoarthritis (Kellgren and Lawrence grade 4)
  4. * failure of a minimum 12 weeks of nonoperative management
  5. * English fluency
  1. * history of inflammatory arthropathy in the same knee
  2. * history of prior open knee surgery in the same knee
  3. * history of prior osteotomy or periarticular fracture
  4. * deformity \> 15 degrees from a neutral mechanical axis
  5. * gross ligamentous incompetence of the medial or lateral collateral ligaments
  6. * musculoskeletal involvement beyond unilateral knee osteoarthritis significantly limiting their function
  7. * unwillingness or inability to participate in the proposed study protocol and follow-up

Contacts and Locations

Study Contact

Jacqueline Lenahan, BS
CONTACT
212-305-8193
jl5092@cumc.columbia.edu

Principal Investigator

Herbert John Cooper, MD
PRINCIPAL_INVESTIGATOR
Columbia University

Study Locations (Sites)

Columbia University Medical Center
New York, New York, 10032
United States

Collaborators and Investigators

Sponsor: Columbia University

  • Herbert John Cooper, MD, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-04-17
Study Completion Date2025-12

Study Record Updates

Study Start Date2019-04-17
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • total knee replacement
  • robotic surgery

Additional Relevant MeSH Terms

  • Osteoarthritis, Knee