Multigen Plus H Study and AMF TT Cones

March 5, 2025 updated by: Limacorporate S.p.a

A Prospective, Post-marketing Study Evaluating Clinical and Radiographic Early Outcomes of Revision Total Knee Arthroplasty with Multigen Plus H Alone or Involving AMF TT Cones.

The aim of this study is to assess the clinical, patient-reported, and radiographic outcomes of a revision Total Knee Arthroplasty with Multigen Plus H and AMF TT Cones.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
      • Gand, Belgium, 9000
        • Recruiting
        • AZ Jan Palfijn Gent
        • Contact:
        • Contact:
          • Wouter Van den Broecke
  • Slovakia
      • Bratislava, Slovakia, 625J+3P
        • Not yet recruiting
        • Nemocnica Bory - Penta Hospital
        • Contact:
          • Libor Necas
          • Phone Number: +421 950105510
        • Contact:
        • Contact:
          • Libor Necas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The subject population for this study includes adult subjects in whom the decision to perform a Total Knee Arthroplasty with Multigen Plus H system, alone or involving the AMF TT cones, must be taken prior to, and independently from, the decision to include the subject into the study.

Description

Inclusion Criteria:

  • Male or female
  • Age ≥ 18 years old
  • Given written informed consent approved by the reference Ethics Committee (EC)
  • Subjects in whom a decision has already been made to perform a Total Knee Arthroplasty with the Multigen Plus H system as per Indication For Use. The decision to implant a Multigen Plus H system, alone or involving the AMF TT cones, must be taken prior to, and independently from, the decision to enrol the subject. This decision should be made in accordance with routine clinical practice at the study site concerned.
  • Subject is able to comply with the protocol

Exclusion Criteria:

  • Age < 18 years old
  • Subjects with any Multigen Plus system contraindication for use, or any AMF TT cones contraindication for use when used in combination with the Multigen Plus H, as reported in the current Instruction For Use.
  • Any clinically significant pathology based on the medical history or any medical intervention that the Investigator feels may affect the study evaluation
  • Female subjects who are pregnant, nursing, or planning a pregnancy
  • Previous knee replacement on the contralateral side within the last year and whose outcome is achieving an KSS < 70 points.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Functional Knee Society Score (KSS)
Time Frame: Month 24
Evaluation of the changes in the Functional Knee Society Score (KSS) after revision TKA
Month 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
KOOS-ADL (Function in Daily Living subdomain)
Time Frame: Month 24
Evaluation of the functional changes in the KOOS-ADL domain after revision TKA
Month 24
VAS Pain score
Time Frame: Month 24
Evaluation of the changes in the VAS Pain score after revision TKA
Month 24
Survivorship of the implant
Time Frame: Month 24
Kaplan-Meier estimate
Month 24
Radiographic implant evaluation and stability assessment
Time Frame: Month 24
Evaluation of progressive Radiolucent Lines after revision TKA
Month 24
Safety evaluation
Time Frame: Intra-operatively, Month 3, Month 12, and Month 24
Incidence, type, and severity of all the Adverse Events (AEs) occurred after revision TKA
Intra-operatively, Month 3, Month 12, and Month 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Limacorporate S.p.a

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
North American Science Associates Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 19, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 13, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • K-23

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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