Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04884542

Multigen Plus H Study and 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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AZ Jan Palfijn Gent, Ghent, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Revision Total Knee Arthroplasty

Device

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

Primary outcomes

  1. Functional Knee Society Score (KSS)

    Time frame: Month 24

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

Secondary outcomes

  1. KOOS-ADL (Function in Daily Living subdomain)

    Time frame: Month 24

    Evaluation of the functional changes in the KOOS-ADL domain after revision TKA

  2. VAS Pain score

    Time frame: Month 24

    Evaluation of the changes in the VAS Pain score after revision TKA

  3. Survivorship of the implant

    Time frame: Month 24

    Kaplan-Meier estimate

  4. Radiographic implant evaluation and stability assessment

    Time frame: Month 24

    Evaluation of progressive Radiolucent Lines after revision TKA

  5. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Francesca Citossi

CONTACT

[email protected]

+39 335 164026

Magalì Mafucci

CONTACT

[email protected]

+39 3316082095

Sponsors and collaborators

Lead sponsor

Limacorporate S.p.a

Industry

Collaborators

  • North American Science Associates Ltd.

Registry information

Official study title

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.

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
May 13, 2021
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.