Rheumatoid Arthritis Clinical Trial
Official title:
Prospective Multicenter Post-market Study of the Zimmer NexGen LPS-Flex Porous Femoral Components
NCT number | NCT01462240 |
Other study ID # | CMU2010-27K |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | May 20, 2008 |
Est. completion date | March 2012 |
Verified date | August 2021 |
Source | Zimmer Biomet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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 clinical outcomes and implant survivorship data for the NexGen LPS-Flex Porous Femoral components.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 2012 |
Est. primary completion date | March 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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.) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Zimmer Biomet |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Survivorship | Based on frequency of adverse events, serious adverse events, adverse device effects, serious adverse device effects and unanticipated adverse device effects or removal of the device summarized using a Kaplan-Meier method and presented with rates (as percentages) and confidence intervals. | 10 Years | |
Secondary | Pain and Functional Performance | Measured by comparing the overall pain and function performances (based on Knee Society Scoring System), survivorship, subject quality of life and radiographic parameters. | 10 years |
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