Multigen Plus H Study and AMF TT Cones

Recruiting

• Conditions: Arthroplasty, Replacement, Knee

• Registration Number: NCT04884542
• Lead Sponsor: Limacorporate S.p.a

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-07
• Study First Submitted QC: 2021-05-07
• Study First Posted: 2021-05-13
• Study Start: 2022-01-19
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-10
• Primary Completion: 2027-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 43

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional Knee Society Score (KSS)	Month 24	Evaluation of the changes in the Functional Knee Society Score (KSS) after revision TKA

Secondary Outcome Measures

Name	Time	Method
Radiographic implant evaluation and stability assessment	Month 24	Evaluation of progressive Radiolucent Lines after revision TKA
KOOS-ADL (Function in Daily Living subdomain)	Month 24	Evaluation of the functional changes in the KOOS-ADL domain after revision TKA
Safety evaluation	Intra-operatively, Month 3, Month 12, and Month 24	Incidence, type, and severity of all the Adverse Events (AEs) occurred after revision TKA
VAS Pain score	Month 24	Evaluation of the changes in the VAS Pain score after revision TKA
Survivorship of the implant	Month 24	Kaplan-Meier estimate

Trial Locations

Locations (2)

AZ Jan Palfijn Gent; 🇧🇪 Gand, Belgium

Nemocnica Bory - Penta Hospital; 🇸🇰 Bratislava, Slovakia