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Sponsored by: |
Hvidovre University Hospital |
Information provided by: | Hvidovre University Hospital |
ClinicalTrials.gov Identifier: | NCT00294528 |
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:
Condition | Intervention | Phase |
Osteoarthritis, Knee |
Device: Nexgen LPS-flex and AGC |
Phase IV |
MedlinePlus related topics: | Osteoarthritis |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Comparing Clinical Outcome of 2 Different Total Knee Prostheses: Nexgen LPS-Flex and AGC |
Estimated Enrollment: | 100 |
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Henrik Husted, consultant | +45 36326037 | henrik.husted@hh.hosp.dk |
Contact: Kristian Stahl-Otte, consultant | +45 36326037 |
Denmark, Hvidovre | |||||
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 |
Hvidovre University Hospital |
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 |
Study ID Numbers: | 1 |
First Received: | February 21, 2006 |
Last Updated: | February 21, 2006 |
ClinicalTrials.gov Identifier: | NCT00294528 |
Health Authority: | Denmark: Scientific Board of Health |
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