Osteoarthritis
Conditions
Keywords
Primary PCL-retaining Total Knee Arthroplasty, Intraoperative Sensors, Ligament Balancing, Clinical Outcomes
Brief summary
The primary objectives of this study are to understand the effects of soft-tissue balancing on Gait, function and rehabilitation potential after sensor-assisted Total Knee Arthroplasty and correlate Intra-operative subjective feel with OrthoSensor Outputs Secondary objectives are to quantify and observe: * Pain medication use * Swelling * Muscle strength and girth * Gait efficiency * Patient satisfaction * Activity levels, functional return (i.e., back to work, resume normal activities) * Patient perception of a balanced knee
Interventions
DEVICESensor-assisted TKR (Verasense)
Verasense is a single use, disposable device embedded with microelectronics into a standard tibial trial to provide dynamic, intraoperative feedback regarding limb alignment, tibiofemoral position and quantitative pressure at peak contact points in the medial and lateral compartments during total knee replacement surgery. Utilizing sensor-derived data, the surgeon can now evaluate intercompartmental loading throughout the range of motion, and correct for soft-tissue abnormalities while receiving real-time feedback regarding joint balance.
PROCEDUREControl - Without the use of Verasense
Patients in this cohort will undergo manual total knee replacement without the use of Verasense
Sponsors
Orthosensor, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject must be a candidate for a primary PCL retaining total knee arthroplasty * Subject must be diagnosed with one or more of the following conditions: osteoarthritis, avascular necrosis, rheumatoid or other inflammatory arthritis, post-traumatic arthritis * Subject is between the age of 45 - 80 years * Subject is likely to be available for all study visits * Subject is able and willing to sign the informed consent and follow study procedures
Exclusion criteria
* Prior total knee arthroplasty, ligament insufficiencies, prior surgeries such as ACL or PCL reconstructions, posterolateral reconstructions, osteotomies, tibia plateau fractures * Range of Motion less than 90 degrees, flexion contracture of more than 20 degrees
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rehabilitation Potential | 6 Months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Society Pain and Functional Scoring (KSS) | 6 month | The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as excellent, good, fair, or poor, a higher value represents a better outcome. |
| Forgotten Joint Score (FJS) | 6 month | The FJS is based on the patients' ability to forget about a joint as a result of the treatment. The FJS assessment is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities. |
| 3D Gait Analysis velocity | 6 Month | 3D gait analysis relates to the range of motion of a joint and the movement velocity. The mean gait speed analysis is considered higher than 1 m/s. |
Countries
United States
Outcome results
None listed