NCT04427722

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).

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

February 25, 2021

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

July 24, 2024

Status Verified

July 1, 2024

Enrollment Period

3.5 years

First QC Date

June 9, 2020

Last Update Submit

July 22, 2024

Conditions

Total Knee Arthroplasty

Keywords

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Implant survivorship based on revision

    Implant survival will be summarized using a Kaplan-Meier method.

    10 years

Secondary Outcomes (3)

  • Functional outcome based on Knee Society Score

    10 years

  • Quality of life based on EQ-5D questionnaire

    10 years

  • Safety assessment

    10 years

Study Arms (1)

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

Interventions

MPS-Flex Total Knee Joint ProsthesesDEVICE

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.

MPS-Flex Total Knee Joint Prostheses

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jizhong Erengy Fengfeng Hospital

Handan, Hebei, China

Location

Study Officials

  • Zhenzhong Guo, Professor

    Jizhong Erengy Fengfeng Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2020

First Posted

June 11, 2020

Study Start

February 25, 2021

Primary Completion

August 31, 2024

Study Completion

December 31, 2024

Last Updated

July 24, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)