Status:
WITHDRAWN
LPS Flex Porous Femoral Components
Lead Sponsor:
Zimmer Biomet
Conditions:
Osteoarthritis
Rheumatoid Arthritis
Eligibility:
All Genders
18-75 years
Brief Summary
This is a prospective multicenter study of the LPS-Flex Porous Femoral Components when used in primary total knee arthroplasty. The purpose of the study is to obtain short-, mid-, and long-term clinic...
Detailed Description
Survival and outcome data on the NexGen LPS-Flex Porous Femoral Components will be done by an analysis of standard scoring system, radiographs and adverse event records. Survivorship will be evaluated...
Eligibility Criteria
Inclusion
- Patient 18-75 years of age, inclusive;
- Patient qualifies for a total knee arthroplasty based on physical exam and medical history including at least one of the following: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle;
- Post-Traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
- Moderate valgus, varus, or flexion deformities;
- Patient has undergone a study related informed consent process;
- Patient is willing and able to provide written consent;
- Patient is willing and able to cooperate in the required post-operative therapy;
- Patient is willing and able to complete scheduled follow-up evaluations.
Exclusion
- Patient has previous history of infection in the affected joint and/or a local or systemic infection that could affect the prosthetic joint;
- Insufficient bone stock on femoral or tibial surfaces;
- Skeletal immaturity;
- Neuropathic arthropathy;
- Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb;
- Stable, painless arthrodesis in a satisfactory functional position;
- Severe instability secondary to the absence of collateral ligament integrity;
- Patient has rheumatoid arthritis and an ulcer of the skin or a history of recurrent breakdown of the skin because of their risk of postoperative infection is greater;
- Patient has a known sensitivity or allergy to one or more of the implanted materials;
- Patient is pregnant or considered a member of a protected population (e.g., prisoner, mental incompetence, unable to understand what clinical trial participation entails, etc.)
Key Trial Info
Start Date :
May 20 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01462240
Start Date
May 20 2008
End Date
March 1 2012
Last Update
August 24 2021
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