Back to resultsProspective Multicenter Post Approval Study of the LPS-Flex Mobile Bearing Knee
Primary Purpose
Osteoarthritis, Traumatic Arthritis, Avascular Necrosis of the Femoral Condyle
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NexGen LPS-Flex Mobile Bearing Knee
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring arthritis, osteoarthritis, degenerative knee disease, avascular necrosis, total knee replacement, TKA
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.
Sites / Locations
- Phoenix Clinical Research
- Advanced Orthopaedics
- Tennessee Orthopaedic Foundation for Education and Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Post-Approval Study Group (Group 2)
Investigational Device Exemption Group (Group 1)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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."
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."
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.
Group 1 - 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.
Group 1 - 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."
Group 1 - 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."
Group 1 - 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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00854295
Brief Title
Prospective Multicenter Post Approval Study of the LPS-Flex Mobile Bearing Knee
Official Title
Prospective Multicenter Post Approval Study of the LPS-Flex Mobile Bearing Knee
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
April 2009 (Actual)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
June 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet
4. Oversight
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Traumatic Arthritis, Avascular Necrosis of the Femoral Condyle, Moderate Varus, Valgus, Flexion Deformities
Keywords
arthritis, osteoarthritis, degenerative knee disease, avascular necrosis, total knee replacement, TKA
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
266 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Post-Approval Study Group (Group 2)
Arm Type
Experimental
Arm Description
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.
Arm Title
Investigational Device Exemption Group (Group 1)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
NexGen LPS-Flex Mobile Bearing Knee
Other Intervention Name(s)
Mobile bearing knee
Intervention Description
Total Knee Replacement
Primary Outcome Measure Information:
Title
Group 2 - Total Knee Society Score (KSS)
Description
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
Title
Group 2 - Number of Subjects With Absence of Radiolucency/Bone Loss
Description
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
Title
Group 2 - Number of Subjects With Absence of Implant Revision
Description
Revision is defined as "No intended, actual, or planned removal of any component of the knee system."
Time Frame
5 year
Title
Group 2 - Number of Subjects With Absence of Severe Knee-Related Complication
Description
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
Title
Group 1 - Total Knee Society Score (KSS)
Description
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
4 year, 5 year, 6 year, 8 year, and 10 year
Title
Group 1 - Number of Subjects With Absence of Radiolucency/Bone Loss
Description
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
10 year
Title
Group 1 - Number of Subjects With Absence of Implant Revision
Description
Revision is defined as "No intended, actual, or planned removal of any component of the knee system."
Time Frame
10 year
Title
Group 1 - Number of Subjects With Absence of Severe Knee-Related Complication
Description
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
10 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin Osborn
Organizational Affiliation
Zimmer Biomet
Official's Role
Study Director
Facility Information:
Facility Name
Phoenix Clinical Research
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Advanced Orthopaedics
City
Auburn Hills
State/Province
Michigan
ZIP/Postal Code
48236-2776
Country
United States
Facility Name
Tennessee Orthopaedic Foundation for Education and Research
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37923
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Prospective Multicenter Post Approval Study of the LPS-Flex Mobile Bearing Knee
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