Status:
COMPLETED
Prospective Multicenter Post Approval Study of the LPS-Flex Mobile Bearing Knee
Lead Sponsor:
Zimmer Biomet
Conditions:
Osteoarthritis
Traumatic Arthritis
Eligibility:
All Genders
Phase:
NA
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-...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
266 Patients enrolled
Trial Details
Trial ID
NCT00854295
Start Date
April 1 2009
End Date
June 1 2021
Last Update
February 14 2023
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Phoenix Clinical Research
Tamarac, Florida, United States, 33321
2
Advanced Orthopaedics
Auburn Hills, Michigan, United States, 48236-2776
3
Tennessee Orthopaedic Foundation for Education and Research
Knoxville, Tennessee, United States, 37923