NCT04814082

Prospective Functional, Gait, and Outcome Comparison Study of Medial Pivot Versus Single Radius Design for Total Knee Arthroplasty

Prospective Functional, Gait, and Outcome Comparison Study of Medial Pivot

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: LifeBridge Health · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Patients with degenerative joint disease can effectively be treated with a primary total knee replacement to reduce pain and improve function in their daily lives. Theoretically, achievement of normal knee motion using a medial pivot design in total knee replacements can be recreated in comparison to single radius designs, which could lead to an improvement in post-surgical outcomes and satisfaction with the procedure. The aim of this study is to compare two types of implant designs (medial pivot and single radius) in a total knee replacement using clinical outcomes, patient reported outcomes, and overall function assessed by a specialized gait laboratory.

Detailed description

This is a single center, cohort study in 100 adult subjects undergoing primary total knee arthroplasty that will receive one of the two total knee device systems. Primary total knee replacement is an effective treatment for relieving pain and improving function for patients with degenerative joint disease. Recently, design of knee implants in a total knee replacement have received increased interest, particularly the medial pivot designs. Single-radius implants are designed to minimize instability throughout the functional range of movement. Medial pivot total knee designs theoretically recreate more normal knee motion when compared to single radius designs. Both implant designs are commonly used for total knee replacements. Outcomes of TKA are evaluated by multiple methods including implant/device survivorship, radiographic assessments, clinical examinations, and patient reported outcome measures (PROMS). Laboratory based gait analysis performed at a specialized research facility is not commonly conducted in patients with positive outcomes post-surgery as this is associated with high cost. There is currently not enough research comparing these two designs directly. Research is required to determine which design may provide better clinical outcomes and satisfaction with the procedure. In addition to your normal standard clinical care, there will be scheduled pre-operative, operative, 6-week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visits.

Conditions

• Osteoarthritis, Knee
• Knee Osteoarthritis
• Osteoarthritis Knees Both
• Osteoarthritis Knee Left
• Osteoarthritis Knee Right
• Knee Pain Chronic
• Knee Disease
• Arthropathy of Knee Joint

Interventions

Type	Name	Description
DEVICE	MicroPort Evolution Medial-Pivot Knee System (Cruciate-substituting)	Medial Pivot Knee System
DEVICE	Stryker Triathlon Tritanium Knee System (Condylar Stabilizing)	Single Radius Design Total Knee System

Timeline

• Start date: 2021-02-01
• Primary completion: 2030-07-01
• Completion: 2030-07-01
• First posted: 2021-03-24
• Last updated: 2025-01-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study