Multigen Plus CCK and AMF TT Cones Follow Up Study

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

Phase

N/A

Condition

Knee Replacement

Treatment

AMF TT cones

Multigen Plus CCK

Clinical Study ID

NCT05314491
K-24
  • Ages > 18
  • All Genders

Study Summary

This study is aimed to provide a clinical and radiographic evaluation of 68 condylar-constrained Total Knee Arthroplasty (TKA) using a single type of prosthesis (Multigen Plus CCK configuration), alone or involving the AMF TT cones, in patients with joint instability or inadequate ligament function, both in complex primary and revision procedures.

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 Multigen Plus system as per Indication For Use. The decision toimplant a Multigen Plus CCK 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.

  • Subjects able to comply with the Study 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 CCK, asreported in the current Instruction For Use.

  • Any clinically significant pathology based on the medical history that theInvestigator 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: 68
Treatment Group(s): 2
Primary Treatment: AMF TT cones
Phase:
Study Start date:
June 21, 2022
Estimated Completion Date:
July 31, 2026

Study Description

This is a post-market, multicentric, prospective, open label study. It is a post-marketing clinical study because the investigational devices are registered, CE marked, and used according to the intended use.

The assignment of any subject involved in the study is determined preoperatively by the aetiology evaluated by the Investigator and falls within the current practice. The decision to use this specific prosthesis design is decided by the Investigators independently and clearly separated from the decision to include the subject in the study.

Baseline measurements (pre-operative clinical assessment and radiographic analysis at discharge) serves as internal control for the assessment of post-operative data.

The study will be carried out in 3 sites in Europe for a total number of 68 study subjects, in whom the decision to implant the Multigen Plus CCK system, alone or in combination with the AMF TT cones, has been taken prior to, and independently from, the decision to include the subject in the study.

The enrolment is competitive until the required recruitment target is met.

The expected number of visits for each study subject is 6, and includes:

  • a pre-operative visit (before the subject receives the Multigen Plus CCK system alone or involving the AMF TT cones).

  • the intra-operative visit (that is the same day of the surgery).

  • the discharge visit (after the surgery according to the clinical practice).

  • the following follow-up visits: at 3 months, 12 months, and 24 months after the surgery.

All eligible subjects who agree to participate in the study will be recruited and monitored throughout the duration of the study. For each visit and for each single study subject, radiographic and clinical data will be assessed up to the 24-month follow-up visit according to the standard of care of the site, when applicable. Also, Adverse Events and Serious Adverse Events will be collected and assessed.

Connect with a study center

  • Hospital Senhora da Oliveira in Guimarães

    Guimarães,
    Portugal

    Active - Recruiting

  • Saints Cyril and Methodius Hospital

    Bratislava,
    Slovakia

    Active - Recruiting

  • Royal Devon and Exeter Hospital

    Exeter,
    United Kingdom

    Active - Recruiting

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