PMCF Study of MPS-Flex Knee System in TKA

  • STATUS
    Recruiting
  • End date
    Dec 31, 2032
  • participants needed
    250
  • sponsor
    Zimmer Biomet
Updated on 2 August 2021

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).

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.

Details
Condition Repair of knee joint, Knee Replacement, total knee replacement, total knee arthroplasty, knee replacements, knee arthroplasty
Clinical Study IdentifierNCT04427722
SponsorZimmer Biomet
Last Modified on2 August 2021

Eligibility

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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