LPS Flex Porous Femoral Components

Withdrawn

• Conditions: Rheumatoid Arthritis; Osteoarthritis; Collagen Disorders; Poly Arthritis; Traumatic Arthritis; Avascular Necrosis of Femoral Condyle
• Interventions: Device: LPS Flex Porous Femoral Components

• Registration Number: NCT01462240
• Lead Sponsor: Zimmer Biomet

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

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.

Study Timeline

• Study Start: 2008-05-20
• Study First Submitted: 2011-10-24
• Study First Submitted QC: 2011-10-28
• Study First Posted: 2011-10-31
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-20
• Last Update Posted: 2021-08-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1 - LPS Flex Pororus Femoral Components	LPS Flex Porous Femoral Components	Patients suffering from severe knee pain and disability.

Primary Outcome Measures

Name	Time	Method
Survivorship	10 Years	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.

Secondary Outcome Measures

Name	Time	Method
Pain and Functional Performance	10 years	Measured by comparing the overall pain and function performances (based on Knee Society Scoring System), survivorship, subject quality of life and radiographic parameters.