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

NCT ID: NCT00854295

Last Updated: 2023-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 266 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2021-06-30

Brief Summary

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.

Detailed Description

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Post-Approval Study Group (Group 2)

Subjects enrolled in a short-term study (5 years) consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by orthopedic surgeons experienced in primary total knee replacement. All Group 2 subjects, both unilateral and bilateral subjects, are in the same arm of the study. As part of the PAS study, these subjects were followed from Pre-operative to 5 years.

Group Type: EXPERIMENTAL

NexGen LPS-Flex Mobile Bearing Knee

Intervention Type: DEVICE

Total Knee Replacement

Investigational Device Exemption Group (Group 1)

Subjects who were implanted with either the LPS Flex Fixed Bearing Knee (control population) or the LPS Flex Mobile Bearing Knee device during the previous Investigational Device Exemption study. As part of the PAS study, these subjects were followed from 4 years to 10 years.

Group Type: EXPERIMENTAL

NexGen LPS-Flex Mobile Bearing Knee

Intervention Type: DEVICE

Total Knee Replacement

Interventions

NexGen LPS-Flex Mobile Bearing Knee

Total Knee Replacement

Intervention Type: DEVICE

Other Intervention Names

Mobile bearing knee

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erin Osborn

Role: STUDY_DIRECTOR

Zimmer Biomet

Locations

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

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

07-100

Identifier Type: -

Identifier Source: org_study_id