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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00294528
• Other study ID #: 1
• Status: Recruiting
• Phase: Phase 4
• First received: February 21, 2006
• Last updated: February 21, 2006
• Start date: January 2004
• Est. completion date: January 2010

Study information

• Verified date: October 2003
• Source: Hvidovre University Hospital
• Contact: Henrik Husted, consultant
• Phone: +45 36326037
• Email: henrik.husted[@]hh.hosp.dk
• Is FDA regulated: No
• Health authority: Denmark: Scientific Board of Health
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Nexgen LPS-flex and AGC

Locations

Country	Name	City	State
Denmark	orthopedic department, section of arthroplasty, Hvidovre University Hospital	Copenhagen	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ROM
Primary	Pain
Primary	Satisfaction
Primary	Feel of prosthesis
Primary	Gait analysis