A Study to Compare the NexGen CR and CR-Flex Knee Implants

June 12, 2012 updated by: Zimmer Biomet

Prospective Randomized Multicenter Study of NexGen CR-Flex Knee

The purpose of this study is to test for significant differences in functional outcomes, specifically pre-operative ROM and post-operative ROM obtained by using a NexGen CR versus a NexGen CR-Flex knee implant. Specifically, it is predicted that an increase in post-operative range of motion will be experienced by patients treated with the NexGen CR-Flex knee implant.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will compare the clinical results of the NexGen CR femoral component with the higher flexion potential of the NexGen CR-Flex femoral component in all patients with degenerative joint disease that require total knee arthroplasty. The primary variable of interest is post-operative range of motion achieved with the two devices, which are implanted with slightly different surgical techniques in patients who may also be subjected to different rehabilitation programs depending on the device they are assigned.

Study Type

Interventional

Enrollment (Actual)

189

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Delaware
      • Milford, Delaware, United States, 19963
        • Dickinson Medical Group, LLC
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Hospital
      • Rockford, Illinois, United States, 61107
        • Rockford Orthopedic Associates
    • Massachusetts
      • Worcester, Massachusetts, United States, 01605
        • University of Massachusetts Memorial Medical Center
    • Michigan
      • Grand Rapids, Michigan, United States, 49525
        • Orthopaedic Associates of Grand Rapids, PC
    • North Carolina
      • Pinehurst, North Carolina, United States, 28374
        • Pinehurst Surgical Center
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Slocum Orthopedics, PC
    • Pennsylvania
      • Clairton, Pennsylvania, United States, 15025
        • The Orthopedic Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age, 21-80 years
  • Sex, Male and Females will be included
  • BMI less than or equal to 39
  • Stable Health, the patient would be able to undergo surgery and participate in a follow-up program based on physical examination and medical history.
  • Patient is willing and able to cooperate in follow-up therapy.
  • Patient exhibits pre-operative radiographic evidenced of joint degeneration consistent with TKA that cannot be treated in non-operative fashion.
  • Patient has stable and functional posterior cruciate and collateral ligaments.
  • Patient has potential to perform higher than average range of motion activities.
  • Operative side range of motion flexion greater than or equal to 120 degrees.
  • Severe knee pain and disability due to degenerative joint disease.
  • Patient or patient's legal representative has signed the Informed Consent form.

Exclusion Criteria:

  • Previous history of infection in the affected joint.
  • Previously failed knee endoprosthesis of any kind.
  • Charcot joint disease or other severe neurosensory deficits.
  • Previous patellectomy
  • Patient is skeletally immature.
  • Grossly insufficient femoral or tibial bone stock.
  • Patient is pregnant.
  • Varus or valgus deformity greater than 20 degrees.
  • Fixed flexion deformity greater than 15 degrees.
  • Previous high tibial osteotomy.
  • Previous femoral osteotomy.
  • Patient is a poor compliance risk, currently treated for ethanol or drug abuse, physical or mental handicap, etc.
  • Loss of musculature or absence of musculoligamentous supporting structures required for adequate soft tissue balance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Study arm will consist of patients that are treated with the NexGen CR-Flex Fixed Bearing Knee.
Device: NexGen CR-Flex Fixed Bearing Knee
NexGen CR-Flex Fixed Bearing femoral component
Other Names:
  • CR-Flex Knee
Active Comparator: 2
Study arm will consist of patients that are treated with the NexGen CR Knee.
Device: NexGen CR Knee
NexGen Complete Knee Solution Cruciate Retaining femoral component
Other Names:
  • CR Knee

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Range of Motion (ROM)
Time Frame: 24 Months
The subject will have the operative joint's range of motion/movement assessed through a series of exercises and bends. The assessor will measure how far the joint bends/moves in each direction by degrees. The measurements are taken at each visit interval and recorded.
24 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Return to Function (RtF) Via Knee Scoiety Score (Modified)
Time Frame: 24 Months

Scores were calculated from responses on a modified Knee Society Score by the enrolled subjects for the stated visit intervals.

Grading for the Knee Society Score is based on a scale from 0-100 and results are estabalished follows: 80-100 = Excellent; 70-79 = Good; 60-69 = Fair; and Below 60 = Poor.
24 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zimmer Biomet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

September 26, 2008

First Submitted That Met QC Criteria

September 29, 2008

First Posted (Estimate)

September 30, 2008

Study Record Updates

Last Update Posted (Estimate)

July 16, 2012

Last Update Submitted That Met QC Criteria

June 12, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-300

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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