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

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).

Study Overview

• Status: Suspended
• Conditions: Total Knee Arthroplasty
• Intervention / Treatment: Device: MPS-Flex Total Knee Joint Prostheses

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.

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• China
  • Hebei
    • Handan, Hebei, China
      • Jizhong Erengy Fengfeng Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population for primary statistical analysis will consist of patients who have already underwent their surgery with MPS-Flex® Total Knee Joint Prostheses for their primary TKA and satisfy eligibility criteria outlined in this section. In order to avoid potential selection bias, each investigator will offer study participation to each consecutive eligible patient presenting as a candidate for primary TKA using the MPS-Flex® Total Knee Joint Prostheses.

Description

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:

  1. Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
  2. Collagen disorders and/or avascular necrosis of the femoral condyle.
  3. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
  4. 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:

  1. A prisoner
  2. Mentally incompetent or unable to understand what participation in the study entails
  3. A known alcohol or drug abuser
  4. Anticipated to be non-compliant

• Meet any of the following contraindications of the product.

  1. Had previous infection in the operative knee joint, and/or has systemic inflection that could affect prosthesis
  2. Insufficient bone stock of tibia or tibia surface
  3. Skeleton immaturity
  4. Neuropathic arthropathy
  5. Osteoporosis, muscle structure or neuromuscular lesions which affects lower limb function
  6. The affected joint occurs fusion in the satisfactory functional position and form stable,
  7. 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant survivorship based on revision	Implant survival will be summarized using a Kaplan-Meier method.	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life based on EQ-5D questionnaire	EQ-5D is a standardized measure of health-related quality of life states consisting of 5 dimensions, namely mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D-5L version was used in the study. Each dimension has 5 responses recording 5 levels of severity (no problems/slight problems/moderate problems/severe problems or extreme problems). The responses to the EQ-5D dimensions are used to obtain a single EQ-5D index value where 1 represents full health and 0 represents death. The questionnaire also includes a vertical, visual analogue scale (EQ VAS) for the respondents to record their self-rated health where the 2 extreme ends of the scale are labelled as 'Best imaginable health state' and 'Worst imaginable health state' respectively.	10 years
Safety assessment	Summarize the category, incidence and frequency of adverse events	10 years
Functional outcome based on Knee Society Score	The Knee Society Scoring System combines an objective physician-derived component with a subjective patient-derived component that evaluates pain relief, functional abilities, satisfaction, and fulfillment of expectations. It consists of four subscales: (1) Objective Knee Score (seven items; 100 points), (2) Satisfaction Score (five items; 40 points), (3) Expectation Score (three items; 15 points), and (4) Functional Activity Score (19 items; 100 points).	10 years

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Principal Investigator: Zhenzhong Guo, Professor, Jizhong Erengy Fengfeng Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2021
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: June 9, 2020
• First Submitted That Met QC Criteria: June 9, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): July 24, 2024
• Last Update Submitted That Met QC Criteria: July 22, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Total Knee Arthroplasty
• Other Study ID Numbers: CSA2019-11K

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No