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NexGen Gender Fixed Bearing Knee Versus NexGen Legacy Knee Posterior Stabilized (LPS) - Flex Fixed Bearing Knee: A Study Comparing Two Different Knee Prostheses

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2009 by Hvidovre University Hospital.
Recruitment status was:  Enrolling by invitation
Zimmer Biomet
Information provided by:
Hvidovre University Hospital Identifier:
First received: May 12, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
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).

Condition Intervention
Total Knee Arthroplasty
Device: NexGen Gender Fixed Bearing Knee prosthesis
Device: NexGen LPS-Flex Fixed Bearing Knee prosthesis

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: NEXGEN Gender Fixed Bearing Knee Versus NEXGEN LPS-Flex Fixed Bearing Knee - a Prospective Randomized Study Comparing Two Different Knee Prostheses

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • 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 ]

Enrollment: 24
Study Start Date: May 2007
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed 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).


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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • female patients scheduled for simultaneous bilateral total knee arthroplasty (TKA) are included
  • bilateral knee disease necessitating bilateral TKA

Exclusion Criteria:

  • male sex
  Contacts and Locations
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Please refer to this study by its identifier: NCT00901329

Hvidovre University Hospital
Hvidovre, Copenhagen, Denmark, 2650
orthopedic department, section of arthroplasty, Hvidovre University Hospital
Copenhagen, Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Zimmer Biomet
  More Information

Responsible Party: Henrik Husted, Orthopedic department, Hvidovre University Hospital, Denmark Identifier: NCT00901329     History of Changes
Other Study ID Numbers: HD2007-0123
Study First Received: May 12, 2009
Last Updated: May 12, 2009

Keywords provided by Hvidovre University Hospital:
functional outcome
gait processed this record on May 25, 2017