Navio Robotic Versus Conventional Total Knee Arthroplasty
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 40 - 85 |
| Updated: | 1/16/2019 |
| Start Date: | July 2019 |
| End Date: | December 31, 2022 |
| Contact: | Emma Jennings, BS |
| Email: | ej2290@cumc.columbia.edu |
| Phone: | 212-305-8193 |
Conventional vs. Robotic-Assisted Total Knee Arthroplasty: A Prospective, Randomized Trial of Clinical, Functional, and Radiographic Outcomes
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.
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.
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.
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.
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
We found this trial at
1
site
630 W 168th St
New York, New York
New York, New York
212-305-2862
Principal Investigator: Herbert John Cooper, MD
Phone: 212-305-6959
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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