Osteoarthritis, Knee Clinical Trial
Official title:
Conventional vs. Robotic-Assisted Total Knee Arthroplasty: A Prospective, Randomized Trial of Clinical, Functional, and Radiographic Outcomes
NCT number | NCT03519269 |
Other study ID # | AAAR6537 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 17, 2019 |
Est. completion date | December 2025 |
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.
Status | Recruiting |
Enrollment | 86 |
Est. completion date | December 2025 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 85 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Columbia University Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University | Smith & Nephew, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Score on Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | The WOMAC is a 24-item questionnaire with 3 subscales measuring pain, stiffness, and physical function. Scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. | Up to 2 years | |
Primary | Score on the Timed Up and Go Test (TUG) | The TUG measures the time (in seconds) it takes a patient to rise from an armed chair, walk 3 meters, turn, and return to sitting in the same chair. The time taken to complete the task is strongly correlated to level of functional mobility, (i.e., the more time taken, the more dependent in activities of daily living). Risk for Falls: high risk (>13.5 seconds), none/low/moderate (<13.5 seconds). | Up to 2 years | |
Secondary | Score on Short-Form 12 Health Questionnaire (SF-12) | The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. Questions were combined, scored, and weighted to create two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | Up to 2 years | |
Secondary | Score on New Knee Society Scores (2011 KSS) | The 2011 KSS is a physician- and patient-derived scoring system that has been validated and demonstrated to be a responsive method for assessing objective and subjective outcomes after TKA. This scale comprises four separate subscales: (a) objective knee score (seven items: 100 points); (b) patient satisfaction score (five items: 40 points); (c) patient expectations score (three items: 15 points); and (d) functional activity score (19 items: 100 points). Score 80-100: Excellent; Score 70-79: Good; Score 60-69: Fair; Score below 60: Poor | Up to 2 years | |
Secondary | Score on Global Rating Score of Knee Function (GRS) | Participants will be asked to rate their perception of knee functional ability on a scale of 0 to 100%. A score of 0 represents a complete disability and a score of 100 represents a level of knee function prior to the patient having any symptoms. | Up to 2 years |
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