Prospective Multicenter Post Approval Study of the LPS-Flex Mobile Bearing Knee

Zimmer Biomet266 enrolled

Overview

The purpose of the study is to assess the long-term performance of the NexGen LPS-Flex Mobile Bearing Knee in the treatment of patients with severe knee pain or degenerative knee disease.

The NexGen LPS-FLex Mobile Bearing Knee received FDA approval for commercial distribution in the US on December 10, 2007. The approval was in accordance with a "condition of approval" to perform a 10-year post approval study to evaluate the longer-term safety and effectiveness of the LPS-Flex Mobile Bearing Knee. The post approval study will consist of patients from the investigational device exemption study arm (Group 1) as well as patients who are eligible for a total knee replacement and have been chosen to receive the LPS-Flex Mobile Knee (Group 2). Group 1 will be followed from 4 years through a total of 10 years from the date of surgery. Group 2 will be followed from pre-op through a total of 5 years from the date of surgery.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

266

Conditions

Osteoarthritis Traumatic Arthritis Avascular Necrosis of the Femoral Condyle Moderate Varus Valgus Flexion Deformities

Interventions

NexGen LPS-Flex Mobile Bearing KneeDEVICE

Total Knee Replacement

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Osteoarthritis * Primary and secondary traumatic arthritis * Avascular necrosis of the femoral condyle * Moderate varus, valgus, or flexion deformities (i.e. valgus/varus deformity of less than or equal to 15 degrees, fixed flexion deformity of less than or equal to 10 degrees) Exclusion Criteria: * Previous history of infection in the affected joint and/or local/systemic infection that may 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 * A stable, painless arthrodesis in a satisfactory functional position * Severe instability secondary to the absence of collateral integrity * Total knee arthroplasty is contraindicated in patients who have rheumatoid arthritis (RA) and an ulcer of the skin or a history of recurrent breakdown of the skin because their risk of postoperative infection is greater. RA patient using steroids may also have increased risk of infection. Late infections in RA patients have been reported 24+ months postoperative. * Patient is a poor compliance risk, i.e., history of ethanol or drug abuse, or mental handicap that would compromise patient compliance with respect to rehabilitation or follow-up * Patient is not willing or able to give informed consent to participate in the follow-up program * Patient is not willing to return for all scheduled follow-up appointments as defined by this protocol.

Locations (3)

Phoenix Clinical Research

Tamarac, Florida, United States

Advanced Orthopaedics

Auburn Hills, Michigan, United States

Tennessee Orthopaedic Foundation for Education and Research

Knoxville, Tennessee, United States

Outcomes

Primary Outcomes

Group 2 - Total Knee Society Score (KSS)

Total Knee Society Score is used to assess pain and function which is scored from 0 to 200 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.

Time frame: Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year

Group 2 - Number of Subjects With Absence of Radiolucency/Bone Loss

Independent radiographic was performed on all required post-operative follow-up intervals and a detailed report was provided at the completion of the study. Each case was expected to have anteroposterio (A/P) and lateral radiographs obtained at all postoperative assessments. An independent review of the radiographs was assessed for progressive radiolucencies over time. Per the protocol, radiographic outcomes are defined as "An absence of subsidence of greater than or equal to 2 millimeters and an absence of both osteolysis and radiolucencies greater than or equal to 2 millimeters as determined by an independent radiographic reviewer."

Time frame: 5 year

Group 2 - Number of Subjects With Absence of Implant Revision

Revision is defined as "No intended, actual, or planned removal of any component of the knee system."

Time frame: 5 year

Group 2 - Number of Subjects With Absence of Severe Knee-Related Complication

All severe knee-related complications are determined by each study investigator. A severe adverse event is any undesirable experience associated with the use of the implant in a patient that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a birth defect. A knee-related complication is an adverse event that has been classified by the investigator to have a relation to the knee.

Time frame: 5 year

Group 1 - Total Knee Society Score (KSS)

Data from ClinicalTrials.gov

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