Do We Need High-Flexing Total Knee Arthroplasty to Improve the Survivorship and to Decrease the Incidence of Osteolysis?

Ewha Womans University111 enrolled

Overview

The purpose of this study is to determine if there are any clinical or ROM differences in total knee arthroplasty with standard NexGen LPS prosthesis and NexGen LPS-Flex prosthesis.

We therefore hypothesized: (1) the survival of the NexGen LPS-Flex prosthesis is better than standard NexGen LPS prosthesis; (2) knee function and range of motion after clinical assessment will be better in the NexGen LPS-Flex group; and (3) the incidence of osteolysis will be lower in the NexGen LPS-Flex prosthesis than standard NexGTne LPS prosthesis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

111

Conditions

Osteoarthritis

Interventions

legacy posterior stabilized high-flexion (NexGen LPS-Flex)DEVICE

NexGen legacy posterior stabilized high-flexion (NexGen LPS-Flex) total knee system

legacy posterior stabilized standard (NexGen LPS)DEVICE

NexGen legacy posterior stabilized standard (NexGen LPS) total knee system

Eligibility

Sex: ALLMin age: 48 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * End-stage osteoarthritis of the knee joint requiring total knee arthroplasty with bilateral disease Exclusion Criteria: * Inflammatory disease * patient with other Lower extremity disease which may affect functional outcome * Neurologic disease effecting patients lower extremity * Revision surgery * Patient not medically cleared for bilateral surgery

Locations (1)

Ewha Womans University Mokdong Hosptial

Seoul, South Korea

Outcomes

Primary Outcomes

Improvement in Knee Society Knee Score

change in knee score will be compared with initial score, until mean follow up of 10.3 year

Time frame: 10 years

Secondary Outcomes

Improvement in the range of motion

change in the range of motion of knee joint will be compared with the initial value, until mean follow up of 10.3 years

Time frame: 10 years

Data from ClinicalTrials.gov

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