LPS Flex Porous Femoral Components
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Osteoarthritis Rheumatoid Arthritis Traumatic Arthritis Poly Arthritis Collagen Disorders Avascular Necrosis of Femoral Condyle |
Device: LPS Flex Porous Femoral Components |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Prospective Multicenter Post-market Study of the Zimmer NexGen LPS-Flex Porous Femoral Components |
- Survivorship [ Time Frame: 10 Years ] [ Designated as safety issue: No ]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.
- Pain and Functional Performance [ Time Frame: 10 years ] [ Designated as safety issue: No ]Measured by comparing the overall pain and function performances (based on Knee Society Scoring System), survivorship, subject quality of life and radiographic parameters.
| Estimated Enrollment: | 300 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | December 2024 |
| Estimated Primary Completion Date: | June 2024 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1 - LPS-Flex Pororus Femoral Components
Patients suffering from severe knee pain and disability.
|
Device: LPS Flex Porous Femoral Components
Porous femoral components in total knee arthroplasty
|
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 by monitoring the frequency and incidence of adverse events, serious adverse events, adverse device effects, serious adverse device effects, and unanticipated adverse device effects. Outcomes will be measured by comparing the overall pain and function performances (based on the Knee Society Scoring System), survivorship, subject quality of life and radiographic parameters of study subjects receiving the LPS-Flex Porous Femoral Components.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Each investigator will screen from this patient populatin patients suffering from severe knee pain and disability who meet the inclusion/exclusion criteria for study participation.
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.)
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Zimmer, Inc. |
| ClinicalTrials.gov Identifier: | NCT01462240 History of Changes |
| Other Study ID Numbers: | CMU2010-27K |
| Study First Received: | October 24, 2011 |
| Last Updated: | March 21, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Zimmer, Inc.:
|
arthritis |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Collagen Diseases Necrosis Osteonecrosis Osteoarthritis Joint Diseases |
Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes Bone Diseases |
ClinicalTrials.gov processed this record on May 19, 2013