Multigen Plus H Study

May 7, 2021 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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

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 Backup

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The subject population for this study includes adult subjects in whom the decision to perform a revision Total Knee Arthroplasty with Multigen Plus H system 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 revision Total Knee Arthroplasty with Multigen Plus H system as per Indication For Use. The decision to implant the Multigen Plus H system must be taken prior to, and independently from, the decision to enrol the subject. This decision should be made in accordance with routine standard of care at the study site.
  • Subject is able to comply with the protocol

Exclusion Criteria:

  • Age < 18 years old
  • Subjects with any Multigen Plus system contraindication for use as reported in the current Instruction For Use
  • Any clinically significant pathology based on the medical history that the Investigator feels may affect the study evaluation
  • Female subjects who are pregnant, nursing, or planning a pregnancy

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

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

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

Limacorporate S.p.a

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 (Anticipated)

July 1, 2021

Primary Completion (Anticipated)

July 1, 2025

Study Completion (Anticipated)

July 1, 2025

Study Registration Dates

First Submitted

May 7, 2021

First Submitted That Met QC Criteria

May 7, 2021

First Posted (Actual)

May 13, 2021

Study Record Updates

Last Update Posted (Actual)

May 13, 2021

Last Update Submitted That Met QC Criteria

May 7, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Other Study ID 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

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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