Comparison of High Flex and Standard Rotating Platform Total Knee Arthroplasty (TKA)

Anderson Orthopaedic Research Institute

Status

Completed

Conditions

Knee Osteoarthritis

Treatments

Device: Rotating Platform High-Flex Cruciate Substituting TKA

Device: Rotating Platform Cruciate Substituting TKA

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01176292

AORI2010-0104

Details and patient eligibility

About

The goal of this study is to determine if the rotating platform high flex design provides improved flexion compared to the standard rotating platform TKA.

Enrollment

142 patients

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 40 to 75 years old
Primary diagnosis of osteoarthritis of the knee
Patients who, in the investigator's opinion, are appropriate candidates for a cemented, rotating platform TKA.
Patients who, in the investigator's opinion, are capable of participation in a clinical trial and reliable enough to return for follow-up appointments.

Exclusion criteria

Pregnant or lactating female subjects
Patients with post-traumatic or inflammatory arthritis
Patients with a fixed flexion contracture of greater than 20 degrees
Patients with advanced hip, spine, or ankle disease
Patients with a BMI greater than 40, where knee flexion may be limited by soft tissues