Multigen Plus H Study

Arthroplasty, Replacement, Knee Clinical Trial

Official title:

A Prospective, Post-marketing Study Evaluating Clinical and Radiographic Early Outcomes of Revision Total Knee Arthroplasty With Multigen Plus H.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04884542
• Other study ID #: K-23
• Status: Not yet recruiting
• Start date: July 2021
• Est. completion date: July 2025

Study information

• Verified date: May 2021
• Source: Limacorporate S.p.a
• Contact: Federica Azzimonti
• Phone: +39 377 5450940
• Email: federica.azzimonti[@]limacorporate.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 43
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee

Intervention

Device:
• Revision Total Knee Arthroplasty
Total Knee Arthroplasty in case of failure of a previous operation.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Limacorporate S.p.a

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Knee Society Score (KSS)	Evaluation of the changes in the Functional Knee Society Score (KSS) after revision TKA	Month 24
Secondary	KOOS-ADL (Function in Daily Living subdomain)	Evaluation of the functional changes in the KOOS-ADL domain after revision TKA	Month 24
Secondary	VAS Pain score	Evaluation of the changes in the VAS Pain score after revision TKA	Month 24
Secondary	Survivorship of the implant	Kaplan-Meier estimate	Month 24
Secondary	Radiographic implant evaluation and stability assessment	Evaluation of progressive Radiolucent Lines after revision TKA	Month 24
Secondary	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