Comparing Clinical Outcome of 2 Different Total Knee Prostheses: Nexgen LPS-Flex Versus AGC
Recruitment status was: Recruiting
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
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Comparing Clinical Outcome of 2 Different Total Knee Prostheses: Nexgen LPS-Flex and AGC|
- Feel of prosthesis
- Gait analysis
|Study Start Date:||January 2004|
|Estimated Study Completion Date:||January 2010|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00294528
|orthopedic department, section of arthroplasty, Hvidovre University Hospital|
|Copenhagen, Hvidovre, Denmark, 2650|
|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|