Status:
COMPLETED
A Study to Compare the NexGen CR and CR-Flex Knee Implants
Lead Sponsor:
Zimmer Biomet
Conditions:
Total Knee Arthroplasty
Osteoarthritis
Eligibility:
All Genders
21-80 years
Phase:
NA
Brief Summary
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 kne...
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 diseas...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
189 Patients enrolled
Trial Details
Trial ID
NCT00761956
Start Date
September 1 2004
End Date
December 1 2010
Last Update
July 16 2012
Active Locations (8)
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1
Dickinson Medical Group, LLC
Milford, Delaware, United States, 19963
2
University of Chicago Hospital
Chicago, Illinois, United States, 60637
3
Rockford Orthopedic Associates
Rockford, Illinois, United States, 61107
4
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01605