Prospective Multicenter Post Approval Study of the LPS-Flex Mobile Bearing Knee (NCT00854295) | Clinical Trial Compass
CompletedNot Applicable
Prospective Multicenter Post Approval Study of the LPS-Flex Mobile Bearing Knee
United States266 participantsStarted 2009-04
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Group 2 - Total Knee Society Score (KSS)
Timeframe: Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year
2
Group 2 - Number of Subjects With Absence of Radiolucency/Bone Loss
Timeframe: 5 year
3
Group 2 - Number of Subjects With Absence of Implant Revision
Timeframe: 5 year
4
Group 2 - Number of Subjects With Absence of Severe Knee-Related Complication
Timeframe: 5 year
5
Group 1 - Total Knee Society Score (KSS)
Timeframe: 4 year, 5 year, 6 year, 8 year, and 10 year
6
Group 1 - Number of Subjects With Absence of Radiolucency/Bone Loss
Timeframe: 10 year
7
Group 1 - Number of Subjects With Absence of Implant Revision