Comparing Clinical Outcome of 2 Different Total Knee Prostheses: Nexgen LPS-Flex and AGC

Hvidovre University Hospital1 site in 1 country100 target enrollmentJanuary 2004

ConditionsOsteoarthritis, Knee

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Osteoarthritis, Knee
Sponsor: Hvidovre University Hospital
Enrollment: 100
Locations: 1
Primary Endpoint: ROM
Last Updated: 20 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A randomized blinded study is conducted comparing 2 different knee prostheses. Range of motion (ROM), pain, feel of prosthesis, satisfaction and ability to do daily activities are registered at intervals up to one year postop, where patients are informed on which prosthesis they received.

We want to:

determine whether an increased ROM is achieved with a high-flex knee compared to a standard knee
and if so, does it matter

Detailed Description

100 patients operated on with unilateral TKR are included and randomized to either prostheses. Patients operated on with bilateral simultaneous TKR receive one of each prostheses but are blinded to which prosthesis is on which side. They have gait analyses performed preop and at intervals up to one year.

Registry

clinicaltrials.gov

Start Date

January 2004

End Date

January 2010

Last Updated

20 years ago

Study Type

Interventional

Study Design

Parallel