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

Phase 4

• Conditions: Osteoarthritis, Knee

• Registration Number: NCT00294528
• Lead Sponsor: Hvidovre University Hospital

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.

Study Timeline

• Status Verified: 2003-10
• Study Start: 2004-01
• Study First Submitted: 2006-02-21
• Study First Submitted QC: 2006-02-21
• Last Update Submitted: 2006-02-21
• Study First Posted: 2006-02-22
• Last Update Posted: 2006-02-22
• Study Completion: 2010-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• age below 75 years and active
• preop ROM at least 120 degress flexion
• BMI below 30
• intact ligaments

Exclusion Criteria

• below 18 years
• unable to understand language or purpose

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
ROM
Pain
Satisfaction
Feel of prosthesis
Gait analysis

Trial Locations

Locations (1)

orthopedic department, section of arthroplasty, Hvidovre University Hospital; 🇩🇰 Copenhagen, Hvidovre, Denmark