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Completed

NCT Number: NCT00854295

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

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.

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Key information

Conditions

Osteoarthritis Arthritis Avascular Necrosis of the Femoral Condyle Bone Diseases Flexion Deformities Genu Valgum Joint Diseases Moderate Varus Musculoskeletal Diseases Necrosis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Traumatic Arthritis Valgus

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Phoenix Clinical Research, Tamarac, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NexGen LPS-Flex Mobile Bearing Knee

Device

Total Knee Replacement

Other names: Mobile bearing knee

Primary outcomes

  1. Group 2 - Total Knee Society Score (KSS)

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

    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.

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

    Time frame: 5 year

    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."

  3. Group 2 - Number of Subjects With Absence of Implant Revision

    Time frame: 5 year

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

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

    Time frame: 5 year

    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.

  5. Group 1 - Total Knee Society Score (KSS)

    Time frame: 4 year, 5 year, 6 year, 8 year, and 10 year

    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.

  6. Group 1 - Number of Subjects With Absence of Radiolucency/Bone Loss

    Time frame: 10 year

    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."

  7. Group 1 - Number of Subjects With Absence of Implant Revision

    Time frame: 10 year

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

  8. Group 1 - Number of Subjects With Absence of Severe Knee-Related Complication

    Time frame: 10 year

    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.

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Registry information

Important dates

Study start
2009
Primary completion
2020
Study completion
2021
First posted
Mar 3, 2009
Registry last updated
Feb 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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