Overview

This trial is active, not recruiting.

Conditions osteoarthritis, traumatic arthritis, avascular necrosis of the femoral condyle, moderate varus, valgus, flexion deformities
Treatment nexgen lps-flex mobile bearing knee
Sponsor Zimmer, Inc.
Start date April 2009
End date December 2019
Trial size 400 participants
Trial identifier NCT00854295, 07-100

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Follow-up of existing IDE study subjects
nexgen lps-flex mobile bearing knee Mobile bearing knee
Total Knee Replacement
(Other)
Newly enrolled study subjects
nexgen lps-flex mobile bearing knee Mobile bearing knee
Total Knee Replacement

Primary Outcomes

Measure
Functional analysis (Knee Scores)
time frame: Group 1 - annual visits for 5 years; Group 2: Pre-op, 6 week, 6 month, and annual for a total of 5 years

Secondary Outcomes

Measure
Radiographic analysis
time frame: Group 1: annual visits for a total of 5 years; Group 2: Pre-op, 6 week, 6 month and annual for a total of 5 years

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

Official title Prospective Multicenter Post Approval Study of the LPS-Flex Mobile Bearing Knee
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 through a total of 10 years from the date of surgery. Group 2 will be followed through a total of 5 years from the date of surgery.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Zimmer, Inc..