Comparing Clinical Outcome of 2 Different Total Knee Prostheses: Nexgen LPS-Flex Versus AGC
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
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|
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|
|Intervention Model:||Parallel Assignment|
|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|
- Feel of prosthesis
- Gait analysis
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
|Contact: Henrik Husted, consultant||+45 firstname.lastname@example.org|
|Contact: Kristian Stahl-Otte, consultant||+45 36326037|
|orthopedic department, section of arthroplasty, Hvidovre University Hospital||Recruiting|
|Copenhagen, Hvidovre, Denmark, 2650|
|Contact: Henrik Husted, consultant +45 36326037 email@example.com|
|Principal Investigator: henrik husted, consultant|
|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|