Multigen Plus H Study and AMF TT Cones

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: Recruiting
• Conditions: Arthroplasty, Replacement, Knee
• Intervention / Treatment: Device: Revision Total Knee Arthroplasty

• Study Type: Observational
• Enrollment (Estimated): 43

Contacts and Locations

• Study Contact: Name: Francesca Citossi; Phone Number: +39 335 164026; Email: francesca.citossi@limacorporate.com
• Study Contact Backup: Name: Magalì Mafucci; Phone Number: +39 3316082095; Email: magali.mafucci@limacorporate.com

Study Locations

• Belgium
  • Gand, Belgium, 9000
    • Recruiting
    • AZ Jan Palfijn Gent
    • Contact: Wouter Van den Broecke; Phone Number: 09 224 71 11; Email: info@janpalfingent.be
    • 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: Email: libor.necas@unm.sk
    • Contact: Libor Necas

Participation Criteria

Eligibility Criteria

• 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

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)	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)	Evaluation of the functional changes in the KOOS-ADL domain after revision TKA	Month 24
VAS Pain score	Evaluation of the changes in the VAS Pain score after revision TKA	Month 24
Survivorship of the implant	Kaplan-Meier estimate	Month 24
Radiographic implant evaluation and stability assessment	Evaluation of progressive Radiolucent Lines after revision TKA	Month 24
Safety evaluation	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

• Sponsor: Limacorporate S.p.a
• Collaborators: North American Science Associates Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2022
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

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): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: March 1, 2025

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
• product manufactured in and exported from the U.S.: No