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

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ClinicalTrials.gov Identifier: NCT00294528
Recruitment Status : Unknown
Verified October 2003 by Hvidovre University Hospital.
Recruitment status was:  Recruiting
First Posted : February 22, 2006
Last Update Posted : February 22, 2006
Sponsor:
Information provided by:
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

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Device: Nexgen LPS-flex and AGC Phase 4

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 Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Comparing Clinical Outcome of 2 Different Total Knee Prostheses: Nexgen LPS-Flex and AGC
Study Start Date : January 2004
Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. ROM
  2. Pain
  3. Satisfaction
  4. Feel of prosthesis
  5. Gait analysis


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00294528


Contacts
Contact: Henrik Husted, consultant +45 36326037 henrik.husted@hh.hosp.dk
Contact: Kristian Stahl-Otte, consultant +45 36326037

Locations
Denmark
orthopedic department, section of arthroplasty, Hvidovre University Hospital Recruiting
Copenhagen, Hvidovre, Denmark, 2650
Contact: Henrik Husted, consultant    +45 36326037    henrik.husted@hh.hosp.dk   
Principal Investigator: henrik husted, consultant         
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
Principal Investigator: Henrik Husted, consultant head of arthroplasty section
Principal Investigator: Kristian Stahl Otte, consultant arthroplasty section
Principal Investigator: Gitte Holm, RN Head nurse of arthroplasty section
Principal Investigator: Helle Krogshøj Hansen, RN nurse

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00294528     History of Changes
Other Study ID Numbers: 1
First Posted: February 22, 2006    Key Record Dates
Last Update Posted: February 22, 2006
Last Verified: October 2003

Keywords provided by Hvidovre University Hospital:
osteoarthritis, knee
total knee arthroplasty
range of motion
satisfaction

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases