Status:
COMPLETED
A Study to Compare the NexGen LPS and LPS-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 obtained by using a NexGen LPS versus a NexGen LPS-Flex knee implant. Specifically, it is predicted that an incr...
Detailed Description
This study will compare the clinical results of the NexGen LPS femoral component with the higher flexion potential of the NexGen LPS-Flex femoral component in all patients with degenerative joint dise...
Eligibility Criteria
Inclusion
- Age, 21-80 years
- Sex, Males and females will be included
- BMI less than or equal to 39 and calf-thigh less than or equal to 90 degrees
- Stable health, the patient would be able to undergo surgery and participate in the follow-up program based on physical examination and medical history.
- Patient is willing and able to cooperate in follow-up therapy.
- Patient exhibits preoperative radiographic evidence of joint degeneration consistent with TKA that cannot be treated in non-operative fashion.
- Patient has stable and functional 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 90 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 :
June 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
331 Patients enrolled
Trial Details
Trial ID
NCT00763386
Start Date
June 1 2001
End Date
March 1 2010
Last Update
June 4 2012
Active Locations (15)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
VA Medical Center
Decatur, Georgia, United States, 30033
3
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62794
4
Joint Replacement Surgeons of Indiana
Indianapolis, Indiana, United States, 46260