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Clinical Trial 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


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00294528
Study type Interventional
Source Hvidovre University Hospital
Contact Henrik Husted, consultant
Phone +45 36326037
Email henrik.husted@hh.hosp.dk
Status Recruiting
Phase Phase 4
Start date January 2004
Completion date January 2010

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