NCT04163445

Comparison of TKAs Using Force Plate Analysis

Comparison of Different TKAs Using Objective Dynamic Functional Analysis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Russell Nevins, M.D. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Knee Osteoarthritis
• Total Knee Arthroplasty
• Knee Injuries
• Knee Arthritis

Interventions

Type	Name	Description
DEVICE	MicroPort Orthopedics EVOLUTION Medial Pivot TKA	Subjects will have been implanted with the Microport Evolution Medial Pivot TKA
DEVICE	Depuy Synthes ATTUNE PCR TKA	Subjects will have been implanted with the Depuy Attune PCR TKA

Timeline

• Start date: 2020-11-11
• Primary completion: 2021-11-01
• Completion: 2022-11-01
• First posted: 2019-11-14
• Last updated: 2021-08-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study