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Recruiting Observational

Multigen Plus CCK and AMF TT Cones Follow Up Study

NCT05314491 · tracked via the Priya Life Science Portugal tracker
Phase
Observational
Started
2022-06-21
Last updated
2025-03-10

Condition(s) studied

Total Knee ArthroplastyRevision Total Knee Arthroplasty

Investigational drug(s) / intervention(s)

Multigen Plus CCKAMF TT cones

Multigen Plus CCK: Total Knee Arthroplasty

AMF TT cones: To fill a proximal tibia or distal femur defect

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 Multigen Plus system as per Indication For Use. The decision to implant a Multigen Plus CCK 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. * Subjects able to comply with the Study 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 CCK, 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. * Previous knee replacement on the contralateral side within the last year and whose outcome is achieving an KSS \< 70 points.

Primary outcome measure(s)

  • Knee Society Score (KSS) — Month 24
    Functional changes in the Knee Society Score (KSS) from pre-operative (baseline) to 2 years after the surgery.

Trial sites (3)

FacilityCityRegionStatus
Hospital Senhora da Oliveira in Guimarães Guimarães Portugal Recruiting
Saints Cyril and Methodius Hospital Bratislava Slovakia Recruiting
Royal Devon and Exeter Hospital Exeter United Kingdom Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05314491 on ClinicalTrials.gov ↗ ← All trials in Portugal