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Clinical Trial Details — Status: Withdrawn

Administrative data

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Status Withdrawn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

Study information

Verified date August 2021
Source Zimmer Biomet
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 clinical outcomes and implant survivorship data for the NexGen LPS-Flex Porous Femoral components.


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.


Recruitment information / eligibility

Status Withdrawn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.)

Study Design


Intervention

Device:
LPS Flex Porous Femoral Components
Porous femoral components in total knee arthroplasty

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Zimmer Biomet

Outcome

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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