Total Knee Replacement
Conditions
Brief summary
As an intraoperative tool, a modern robotic total knee arthroplasty (TKA) system should be able to identify a patient's native femoral and tibial anatomy, as well as, assess ligament tension and gap balance. The surgeon in real time is then able to develop and execute a patient specific plan in terms of component size, alignment and rotation. In our institution we have begun to use, the OMNIBotics Knee system (Corin), which utilizes an active motorized knee spacer, BalanceBot, to objectively measure ligament tension and gap balance after the tibia has been cut and its alignment confirmed. This information is then processed through the OMNIbotics computer algorithm to appropriately size, align, and rotate the femur component to balance the flexion and extension gaps. The purpose of this study is to perform a randomized pilot study looking for an effect on early functional outcomes comparing robotic assisted TKA (RATKA) versus conventional TKA technique.
Interventions
PROCEDURETotal knee replacement using Omnibot Knee System
total knee replacement with robotic assistance
PROCEDUREConventional Total knee replacement
Conventional total knee replacement without robotic assistance
DEVICEOmnibot Robotic Knee System
utilizes an active motorized knee spacer to measure ligament tension and gap balance after the tibia has been cut during surgery
Sponsors
Rothman Institute Orthopaedics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* All unilateral primary knee arthroplasties performed by the investigator participating in this study will be eligible for inclusion * Diagnosis of primary osteoarthritis
Exclusion criteria
* Revision surgery * Bilateral knee surgery * Age \<18 or \>80 * BMI \>40 * Baseline lower extremity strength less than 5/5 * History of chronic narcotic use, defined as more than 5mg of oxycodone q4 hours * Functionally limiting spine disease * Other functionally limiting lower extremity disorder (i.e. symptomatic ipsilateral hip disease) * Patients who cannot perform the baseline functional tests * Allergy/contraindication to protocol medications * Post-traumatic arthritis * Inflammatory arthritis * Pregnancy * Prisoners * Patients receiving care as a result of a worker's compensable injury * General anesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| early functional outcomes #1 | 6 months | This will be measured by the timed-up-and-go test. |
| Early functional outcomes #2 | 6 months | This will be measured by the stair climbing test. |
Countries
United States
Outcome results
None listed