Comparison of TKAs Using Force Plate Analysis
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- 40
Summary
- Conditions
- Knee Arthritis
- Knee Injuries
- Knee Osteoarthritis
- Total Knee Arthroplasty
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Investigator, Outcomes Assessor)Masking Description: The patient will be randomized to one of 2 treatment arms using a random number generator. The care provider will not be blinded as he will be implanting the device and following the patients' progress in clinic postoperatively, including radiographs which will show the implants. He will be blinded, however, to the results of the KOOS score and the data derived from the force plate analysis. The research assistants performing those assessments will be blinded to which treatment arm the patient belongs to.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
48 patients with primary osteoarthritis of the knee who have been appropriately designated for treatment with a total knee arthroplasty (TKA) will be randomly assigned to one of two groups; one group (24 patients) will receive a Depuy Attune PCR knee implant, and one group (24 patients) will receive...
48 patients with primary osteoarthritis of the knee who have been appropriately designated for treatment with a total knee arthroplasty (TKA) will be randomly assigned to one of two groups; one group (24 patients) will receive a Depuy Attune PCR knee implant, and one group (24 patients) will receive a MicroPort Orthopedics Evolution Medial Pivot knee implant utilizing standard and modern techniques. These two implants are designed to recreate the kinematic motion of a native knee articulation using different biomechanical design philosophies. The patients will be monitored post-operatively using subjective and objective measures. Subjective patient reported outcomes will be analyzed using the Knee Injury and Osteoarthritis Outcome Score (KOOS), recorded preoperatively, as well as at 6 weeks, and 3 months postoperatively. Objective outcomes will be measured by having the patients perform four activities over force plates that will measure the amount of force a patient generates. The four activities will be: walking, standing from a seated position in a chair, squatting to a seated position, and walking up stairs. These objective measures will also be recorded preoperatively, 6 weeks, and 3 months postoperatively. The patient reported outcomes and the objective measures will then be compared between the two groups.
Tracking Information
- NCT #
- NCT04163445
- Collaborators
- MicroPort Orthopedics Inc.
- Investigators
- Principal Investigator: Russell Nevins Desert Orthopedics
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