NCT01551472

Post Market Study of the 3DKnee™ With E-plus Insert

Prospective Multicenter Open Label Study Examining the Mid- and Long-term Safety and Efficacy of the 3DKnee™ System With Vitamin E UHMWPE Tibial Inserts (3DKnee™ With E-plus Insert)

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 175 (actual)
• Sponsor: Encore Medical, L.P. · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the use and efficacy of the 3DKnee™ System using Vitamin E UHMWPE tibial inserts for total knee replacement surgery.

Detailed description

Total knee replacement surgery is widely accepted as effective treatment for degenerative joint disease (DJD), osteoarthritis and rheumatoid arthritis. Relief of patient pain and return of mobility are the primary goals that can be accomplished by this surgery. Currently available prosthetic designs accomplish these goals and the surgery has been defined as one of the most successful operations available to improve the quality of life for patients with DJD. This study will evaluate subjects who are candidates for a total knee replacement and meet the indications for use criteria for the 3DKnee™ System with vitamin E UHMWPE tibial inserts (VE).

Conditions

• Degenerative Joint Disease
• Osteoarthritis
• Traumatic Arthritis

Interventions

Type	Name	Description
DEVICE	3DKnee™ System with Vitamin E UHMWPE Tibial Inserts	This device is part of a total knee replacement system utilized in treating patients who are candidates for primary cemented total knee arthroplasty or revision arthroplasty where bone loss is minimal and the collateral ligaments are intact. It is intended to aid the surgeon in relieving the patient of knee pain and restoring knee joint function.

Timeline

• Start date: 2012-04-01
• Primary completion: 2022-01-01
• Completion: 2022-01-01
• First posted: 2012-03-12
• Last updated: 2022-03-31

Locations

6 sites across 1 country: United States