Total Knee Arthroplasty Clinical Trial
Official title:
NEXGEN Gender Fixed Bearing Knee Versus NEXGEN LPS-Flex Fixed Bearing Knee - a Prospective Randomized Study Comparing Two Different Knee Prostheses
The purpose of this trial is to study potential differences between two prostheses, including: "feel of prosthesis" (i.e., how natural does the prosthesis feel), range of motion (ROM), pain perception for each prosthesis, satisfaction, patella tracking and quantification of the removed bone anterior on the femur (weight).
Status | Enrolling by invitation |
Enrollment | 24 |
Est. completion date | December 2010 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - female patients scheduled for simultaneous bilateral total knee arthroplasty (TKA) are included - bilateral knee disease necessitating bilateral TKA Exclusion Criteria: - male sex |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | orthopedic department, section of arthroplasty, Hvidovre University Hospital | Copenhagen | Hvidovre |
Denmark | Hvidovre University Hospital | Hvidovre | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Hvidovre University Hospital | Zimmer, Inc. |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | follow-up at 6 weeks, 3 months, 6 months and one year. - knee-score and function score - feel of prosthesis (VAS 0-10) - ROM (max passive and active ROM is measured using a goniometer) - pain (VAS 0-10) - satisfaction (VAS 0-10) | 1 year | Yes |
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