Multigen Plus H Study and AMF TT Cones

NCT04884542 | Recruiting

• 1 other identifier: K-23
• Study Type: observational
• Target: 43
• Locations: 2 countries
• Sites: 2

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.

Conditions

Arthroplasty, Replacement, Knee

Outcome Measures

Primary Outcomes (1)

• Functional Knee Society Score (KSS)

  Evaluation of the changes in the Functional Knee Society Score (KSS) after revision TKA

  Month 24

Secondary Outcomes (5)

• KOOS-ADL (Function in Daily Living subdomain)

  Month 24

• VAS Pain score

  Month 24

• Survivorship of the implant

  Month 24

• Radiographic implant evaluation and stability assessment

  Month 24

• Safety evaluation

  Intra-operatively, Month 3, Month 12, and Month 24

Interventions

Revision Total Knee Arthroplasty DEVICE

Total Knee Arthroplasty in case of failure of a previous operation.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Limacorporate S.p.a: lead
• North American Science Associates Ltd.: collaborator

Study Sites (2)

AZ Jan Palfijn Gent

Ghent, 9000, Belgium

RECRUITING

Nemocnica Bory - Penta Hospital

Bratislava, 625J+3P, Slovakia

NOT YET RECRUITING

Central Study Contacts

Francesca Citossi

CONTACT

+39 335 164026; francesca.citossi@limacorporate.com

Magalì Mafucci

CONTACT

+39 3316082095; magali.mafucci@limacorporate.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 13, 2021
• Study Start: January 19, 2022
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); SL (1)