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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Zimmer, Inc.
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00901329
First received: May 12, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

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).

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00901329

Locations
Denmark
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, Inc.
  More Information

No publications provided

Responsible Party: Henrik Husted, Orthopedic department, Hvidovre University Hospital, Denmark
ClinicalTrials.gov Identifier: NCT00901329     History of Changes
Other Study ID Numbers: HD2007-0123
Study First Received: May 12, 2009
Last Updated: May 12, 2009
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Hvidovre University Hospital:
TKA
functional outcome
pain
ROM
gait

ClinicalTrials.gov processed this record on August 27, 2014