Clinical trial NCT03519269: Navio Robotic Versus Conventional Total Knee Arthroplasty
Official title: Conventional vs. Robotic-Assisted Total Knee Arthroplasty: A Prospective, Randomized Trial of Clinical, Functional, and Radiographic Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: total knee replacement
robotic surgery
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Smith & Nephew, Inc.
First posted: 2018-05-08
Enrollment: 86
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Total Knee Arthroplasty (TKA) is a widespread orthopaedic procedure for restoring functionality and minimizing pain due to end stage osteoarthritis. Conventional TKA, well-accepted as the standard of care, is performed with manual instrumentation guided by intramedullary or extramedullary alignment rods, as well as rotational guides that are not patient-specific. Despite continued improvement in manual instrumentation, postoperative malalignment is still reported in a significant number of patients when these manual instruments are used. Robotic-assisted TKA was developed specifically to improve surgical accuracy, and has been shown to significantly improve accuracy of alignment and joint-line restoration. However, these improvements came at the cost of higher complication rates and were not shown to translate into meaningful clinical outcomes with these first-generation systems. Newer-generation robotic technology offers several advantages over earlier versions including the potential to dynamically assess soft tissues over a range of motion and the ability to use haptic control in bone preparation. Modern robotic-assisted knee surgery has also demonstrated superior outcomes over conventional instrumentation in unicompartmental knee arthroplasty (UKA). This newer-generation of robotic technology, which has quickly become the standard-of-care for many knee surgeons who perform UKA, has recently been approved by the United States Food and Drug Administration (FDA) for use in TKA. Prior to consideration of widespread adoption of this newer technology in patients undergoing TKA, well-designed clinical trials are necessary to study its efficacy in this population. The proposed study evaluates the efficacy of robotic-assistance in patients between 40 and 85 years old with end-stage knee osteoarthritis or degenerative joint disease undergoing TKA. It is designed as a prospective, randomized trial where patients are blinded to their treatment arm. Patients will be randomized to conventional vs. robotically-assisted techniques in the operating room and, other than the surgical technique, will receive the same perioperative care and identical implants. The investigators aim to measure utility of robotic-assisted TKA through a range of early and short-term clinical, functional, and radiographic outcome measures.

Eligibility criteria: 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

Primary outcomes:
measure: Score on Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: Up to 2 years
measure: Score on the Timed Up and Go Test (TUG)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Score on Short-Form 12 Health Questionnaire (SF-12)
timeFrame: Up to 2 years
measure: Score on New Knee Society Scores (2011 KSS)
timeFrame: Up to 2 years
measure: Score on Global Rating Score of Knee Function (GRS)
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Herbert John Cooper, MD
role: PRINCIPAL_INVESTIGATOR
References: