The purpose of this study is to evaluate performance of two modern total knee arthroplasty designs using patient reported outcomes and force exhibited during various activities of daily living.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
Subjects will have been implanted with the Microport Evolution Medial Pivot TKA
Subjects will have been implanted with the Depuy Attune PCR TKA
Desert Orthopaedic Center
Las Vegas, Nevada, United States
RECRUITINGKnee Injury and Osteoarthritis Outcome Score
KOOS Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms
Time frame: pre-operatively
Knee Injury and Osteoarthritis Outcome Score
KOOS Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms
Time frame: 6 weeks post-operatively
Knee Injury and Osteoarthritis Outcome Score
KOOS Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms
Time frame: 3 months post-operatively
Force generated by operative extremity - walking
Distribution of maximum force between implanted and non- implanted leg during walking
Time frame: pre-operatively
Force generated by operative extremity - walking
Distribution of maximum force between implanted and non- implanted leg during walking
Time frame: 6 weeks post-operatively
Force generated by operative extremity - walking
Distribution of maximum force between implanted and non- implanted leg during walking
Time frame: 3 months post-operatively
Force generated by operative extremity - standing from seated position
Distribution of maximum force between implanted and non- implanted leg during standing from a seated position in a chair
Time frame: pre-operatively
Force generated by operative extremity - standing from seated position
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Distribution of maximum force between implanted and non- implanted leg during standing from a seated position in a chair
Time frame: 6 weeks post-operatively
Force generated by operative extremity - standing from seated position
Distribution of maximum force between implanted and non- implanted leg during standing from a seated position in a chair
Time frame: 3 months post-operatively
Force generated by operative extremity - squatting to a seated position
Distribution of maximum force between implanted and non- implanted leg during squatting to a seated position
Time frame: pre-operatively
Force generated by operative extremity - squatting to a seated position
Distribution of maximum force between implanted and non- implanted leg during squatting to a seated position
Time frame: 6 weeks post-operatively
Force generated by operative extremity - squatting to a seated position
Distribution of maximum force between implanted and non- implanted leg during squatting to a seated position
Time frame: 3 months post-operatively
Force generated by operative extremity - walking up stairs
Distribution of maximum force between implanted and non- implanted leg during walking up stairs
Time frame: pre-operatively
Force generated by operative extremity - walking up stairs
Distribution of maximum force between implanted and non- implanted leg during walking up stairs
Time frame: 6 weeks post-operatively
Force generated by operative extremity - walking up stairs
Distribution of maximum force between implanted and non- implanted leg during walking up stairs
Time frame: 3 months post-operatively