Clinical trial NCT04163445: Comparison of TKAs Using Force Plate Analysis
Official title: Comparison of Different TKAs Using Objective Dynamic Functional Analysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Total Knee Arthroplasty
Knee Injuries
Knee Arthritis
Lead sponsor: Desert Orthopedic Center
Sponsor class: OTHER
Collaborators: name: MicroPort Orthopedics Inc.
First posted: 2019-11-14
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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 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.

Eligibility criteria: Inclusion Criteria:

* Subjects who have been appropriately designated for treatment with a primary total knee arthroplasty
* Subjects who are willing to participate and are willing to sign the Informed Consent/HIPPA documents.

Exclusion Criteria:

* Subjects who are unsuitable candidates for the two types of knee implants under investigation.
* Subjects with significant deformities or arthritis that might affect the procedural decision making, expected outcomes and functions are total knee arthroplasty.
* Subjects with significant comorbidities that might be at an increased risk of post-operative complications.
* Subjects who are unwilling to sign Informed Consent/HIPAA documents.
* Subjects who cannot perform the required activities after the surgery.

Primary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score
timeFrame: pre-operatively
measure: Knee Injury and Osteoarthritis Outcome Score
timeFrame: 6 weeks post-operatively
measure: Knee Injury and Osteoarthritis Outcome Score
timeFrame: 3 months post-operatively
measure: Force generated by operative extremity - walking
timeFrame: pre-operatively
measure: Force generated by operative extremity - walking
timeFrame: 6 weeks post-operatively
measure: Force generated by operative extremity - walking
timeFrame: 3 months post-operatively
measure: Force generated by operative extremity - standing from seated position
timeFrame: pre-operatively
measure: Force generated by operative extremity - standing from seated position
timeFrame: 6 weeks post-operatively
measure: Force generated by operative extremity - standing from seated position
timeFrame: 3 months post-operatively
measure: Force generated by operative extremity - squatting to a seated position
timeFrame: pre-operatively
measure: Force generated by operative extremity - squatting to a seated position
timeFrame: 6 weeks post-operatively
measure: Force generated by operative extremity - squatting to a seated position
timeFrame: 3 months post-operatively
measure: Force generated by operative extremity - walking up stairs
timeFrame: pre-operatively
measure: Force generated by operative extremity - walking up stairs
timeFrame: 6 weeks post-operatively
measure: Force generated by operative extremity - walking up stairs
timeFrame: 3 months post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Desert Orthopaedic Center
state: Nevada
Study officials:
affiliation: Desert Orthopedics
name: Russell Nevins
role: PRINCIPAL_INVESTIGATOR
References: