Clinical trial NCT04427722: PMCF Study of MPS-Flex® Knee System in TKA
Official title: A Multi-Centre Post Market Clinical Follow-Up Study of MPS-Flex® Total Knee Joint Prostheses in Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Total Knee Arthroplasty
Keywords: Total Knee Arthroplasty
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2020-06-11
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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:

  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

Primary outcomes:
measure: Implant survivorship based on revision
timeFrame: 10 years
Secondary outcomes:
measure: Functional outcome based on Knee Society Score
timeFrame: 10 years
measure: Quality of life based on EQ-5D questionnaire
timeFrame: 10 years
measure: Safety assessment
timeFrame: 10 years
Other outcomes:
Locations:
city: Handan
country: China
facility: Jizhong Erengy Fengfeng Hospital
state: Hebei
Study officials:
affiliation: Jizhong Erengy Fengfeng Hospital
name: Zhenzhong Guo, Professor
role: PRINCIPAL_INVESTIGATOR
References: