Multigen Plus H Study and AMF TT Cones

Last updated: March 5, 2025
Sponsor: Limacorporate S.p.a
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Revision Total Knee Arthroplasty

Clinical Study ID

NCT04884542
K-23
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 KneeArthroplasty with the Multigen Plus H system as per Indication For Use. The decisionto implant a Multigen Plus H system, alone or involving the AMF TT cones, must betaken prior to, and independently from, the decision to enrol the subject. Thisdecision should be made in accordance with routine clinical practice at the studysite concerned.

  • Subject is able to comply with the protocol

Exclusion

Exclusion Criteria:

  • Age < 18 years old

  • Subjects with any Multigen Plus system contraindication for use, or any AMF TT conescontraindication for use when used in combination with the Multigen Plus H, asreported in the current Instruction For Use.

  • Any clinically significant pathology based on the medical history or any medicalintervention 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 whoseoutcome is achieving an KSS < 70 points.

Study Design

Total Participants: 43
Treatment Group(s): 1
Primary Treatment: Revision Total Knee Arthroplasty
Phase:
Study Start date:
January 19, 2022
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • AZ Jan Palfijn Gent

    Gand, 9000
    Belgium

    Active - Recruiting

  • Nemocnica Bory - Penta Hospital

    Bratislava, 625J+3P
    Slovakia

    Site Not Available

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