NexGen Gender Fixed Bearing Knee Versus NexGen Legacy Knee Posterior Stabilized (LPS) - Flex Fixed Bearing Knee: A Study Comparing Two Different Knee Prostheses
|ClinicalTrials.gov Identifier: NCT00901329|
Recruitment Status : Unknown
Verified May 2009 by Hvidovre University Hospital.
Recruitment status was: Enrolling by invitation
First Posted : May 13, 2009
Last Update Posted : May 13, 2009
|Condition or disease||Intervention/treatment||Phase|
|Total Knee Arthroplasty||Device: NexGen Gender Fixed Bearing Knee prosthesis Device: NexGen LPS-Flex Fixed Bearing Knee prosthesis||Not Applicable|
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).
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.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||NEXGEN Gender Fixed Bearing Knee Versus NEXGEN LPS-Flex Fixed Bearing Knee - a Prospective Randomized Study Comparing Two Different Knee Prostheses|
|Study Start Date :||May 2007|
|Estimated Primary Completion Date :||December 2009|
|Estimated Study Completion Date :||December 2010|
|Experimental: 1: Gender prosthesis||
Device: NexGen Gender Fixed Bearing Knee prosthesis
new female prosthesis
|Active Comparator: 2: LPS flex prosthesis||
Device: NexGen LPS-Flex Fixed Bearing Knee prosthesis
standard knee prosthesis
- 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) [ Time Frame: 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00901329
|Hvidovre University Hospital|
|Hvidovre, Copenhagen, Denmark, 2650|
|orthopedic department, section of arthroplasty, Hvidovre University Hospital|
|Copenhagen, Hvidovre, Denmark, 2650|