Prospective Multicenter Post Approval Study of the LPS-Flex Mobile Bearing Knee
Completed · Not applicable
Conditions studied: Osteoarthritis, Traumatic Arthritis, Avascular Necrosis of the Femoral Condyle, Moderate Varus, Valgus, Flexion Deformities
In brief
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.
Key facts
- Study ID
- NCT00854295
- Run by
- Zimmer Biomet
- People needed
- 266
- Starts
- 2009-04-01
- Expected to finish
- 2021-06-01
- Last updated by the study team
- 2023-02-14
Who can join
Age: any. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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