A Multi-Centre Post Market Clinical Follow-Up Study of MPS-Flex® Total Knee Joint Prostheses in Total Knee Arthroplasty
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Total Knee Arthroplasty
- Sponsor
- Zimmer Biomet
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Implant survivorship based on revision
- Status
- Suspended
- Last Updated
- last year
Overview
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 (TKA).
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. Patient demographic and operative information will be collected retrospectively. Postoperative clinical outcome, radiographic assessment and adverse events will be collected prospectively starting from the first year of postoperative follow up visit. All study subjects have undergone routine preoperative clinical evaluations prior to their THA, and implanted MPS-Flex® Total Knee Joint Prostheses in accordance to indications and intended use, and appropriate surgical technique(s) will be invited to participate in the study at their first year of postoperative follow up visit, and sign ICF.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •A patient must not meet the following criteria to be eligible for participation:
- •The patient is:
- •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
Outcomes
Primary Outcomes
Implant survivorship based on revision
Time Frame: 10 years
Implant survival will be summarized using a Kaplan-Meier method.
Secondary Outcomes
- Safety assessment(10 years)
- Functional outcome based on Knee Society Score(10 years)
- Quality of life based on EQ-5D questionnaire(10 years)