Status:
SUSPENDED
PMCF Study of MPS-Flex® Knee System in TKA
Lead Sponsor:
Zimmer Biomet
Conditions:
Total Knee Arthroplasty
Eligibility:
All Genders
18-85 years
Brief Summary
The objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available MPS-Flex® Total Knee Joint Prostheses used in primary total knee arthroplasty (T...
Detailed Description
This is a retrospective and prospective, multi-centre, post-market clinical follow-up study involving orthopedic surgeons skilled in TKA and experienced implanting the devices included in this study. ...
Eligibility Criteria
Inclusion
- A patient must meet the following criteria to be eligible for participation:
- Age 18 to 75 years old, inclusive.
- Had a primary unilateral or bilateral (simultaneous or staged)TKA based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following:
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
- Collagen disorders and/or avascular necrosis of the femoral condyle.
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
- Moderate valgus, varus, or flexion deformities.
- Had received MPS-Flex® Total Knee Joint Prostheses per the approved indications for use for the TKA.
- Willing and able to provide written informed consent by signing and dating the EC approved informed consent form.
- Willing and able to complete scheduled study procedures and follow-up evaluations.
Exclusion
- A patient must not meet the following criteria to be eligible for participation:
- The patient is:
- A prisoner
- Mentally incompetent or unable to understand what participation in the study entails
- A known alcohol or drug abuser
- Anticipated to be non-compliant
- Meet any of the following contraindications of the product.
- Had previous infection in the operative knee joint, and/or has systemic inflection that could affect prosthesis
- Insufficient bone stock of tibia or tibia surface
- Skeleton immaturity
- Neuropathic arthropathy
- Osteoporosis, muscle structure or neuromuscular lesions which affects lower limb function
- The affected joint occurs fusion in the satisfactory functional position and form stable,
- A history of rheumatoid arthritis with skin ulcers or recurrent skin damage
- Has a diagnosed systemic disease that could affect his/her safety or the study outcome.
- Known sensitivity or allergic reaction to one or more of the implanted materials.
- Known local bone tumors and/or cysts in the operative knee
- Known to be pregnant
- Body Mass Index (BMI) ≥ 40
Key Trial Info
Start Date :
February 25 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT04427722
Start Date
February 25 2021
End Date
December 31 2024
Last Update
July 24 2024
Active Locations (1)
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1
Jizhong Erengy Fengfeng Hospital
Handan, Hebei, China