NCT04427722

PMCF Study of MPS-Flex® Knee System in TKA

A Multi-Centre Post Market Clinical Follow-Up Study of MPS-Flex® Total Knee Joint Prostheses in Total Knee Arthroplasty

• Status: Suspended
• Phase: —
• Study type: Observational
• Enrollment: 250 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Total Knee Arthroplasty

Interventions

Type	Name	Description
DEVICE	MPS-Flex Total Knee Joint Prostheses	Patients who have received MPS-Flex Total Knee Joint Prostheses for their primary TKA and meet the Patient Selection Criteria outlined in the study protocol.

Timeline

• Start date: 2021-02-25
• Primary completion: 2024-08-31
• Completion: 2024-12-31
• First posted: 2020-06-11
• Last updated: 2024-07-24

Locations

1 site across 1 country: China