NexGen Gender Fixed Bearing Knee Versus NexGen Legacy Knee Posterior Stabilized (LPS) - Flex Fixed Bearing Knee: A Study Comparing Two Different Knee Prostheses
Summary
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).
Description
The present study compares the Gender prosthesis against the LPS-flex in a bilateral study, where patients are given two different prostheses: Gender on one side and LPS-flex on the other side. Patients are blinded to which prosthesis is selected for which side. The potential advantages of the Gender prosthesis include: less post-op pain due to better sizing (less overhang), less post-op patellofemoral pain and less compromised extensor mechanism and better patella tracking (due to less overstuffing of the patellofemoral joint).
Design:
The study is prospective, randomized, comparative and blinded. 24 female patients scheduled for simultaneous bilateral total knee arthroplasty are included (48 knees).
Power calculations cannot be performed as to how many patients are needed since no previous studies have been conducted.
All patients are included and operated by consultant Henrik Husted.
Methods:
Patients are randomized to which side is operated with which prosthesis (LPS-flex or Gender); the operations are performed using standard instrumentation and standard approaches.
At the operation the weight of the cut bone from the anterior femur is noted for each side. Before discharge radiographs including skyline views are performed to evaluate patella tracking (and are repeated at the final out-patient check 1 year post-op).
Gait analyses are performed before operation and 1 year post-op. All other procedures are standard procedures already implemented in the department.
Patients follow an accelerated track (ANORAK, 1,2) with an intended LOS of 4 days for bilaterally operated knee-arthroplasties, all patients are discharged directly to their homes.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Total Knee Arthroplasty
Intervention
NexGen Gender Fixed Bearing Knee prosthesis, NexGen LPS-Flex Fixed Bearing Knee prosthesis
Location
Hvidovre University Hospital
Hvidovre
Copenhagen
Denmark
2650
Status
Enrolling by invitation
Source
Hvidovre University Hospital
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00901329
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Knee Prosthesis
Replacement for a knee joint.
Tooth Preparation, Prosthodontic
The selected form given to a natural tooth when it is reduced by instrumentation to receive a prosthesis (e.g., artificial crown or a retainer for a fixed or removable prosthesis). The selection of the form is guided by clinical circumstances and physical properties of the materials that make up the prosthesis. (Boucher's Clinical Dental Terminology, 4th ed, p239)
Weight-bearing
The physical state of supporting an applied load. This often refers to the weight-bearing bones or joints that support the body's weight, especially those in the spine, hip, knee, and foot.
Gender Identity
A person's concept of self as being male and masculine or female and feminine, or ambivalent, based in part on physical characteristics, parental responses, and psychological and social pressures. It is the internal experience of gender role.
Dental Abutments
Natural teeth or teeth roots used as anchorage for a fixed or removable denture or other prosthesis (such as an implant) serving the same purpose.
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