NCT05314491 Multigen Plus CCK and AMF TT Cones Follow Up Study
| NCT ID | NCT05314491 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Limacorporate S.p.a |
| Condition | Total Knee Arthroplasty |
| Study Type | OBSERVATIONAL |
| Enrollment | 68 participants |
| Start Date | 2022-06-21 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 68 participants in total. It began in 2022-06-21 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Francesca Citossi, CIS Manager Europe & APAC
✉ francesca.citossi@limacorporate.com📞 +39 335 1640260
Frequently Asked Questions
Who can join the NCT05314491 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Total Knee Arthroplasty. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05314491 currently recruiting?
Yes, NCT05314491 is actively recruiting participants. Contact the research team at francesca.citossi@limacorporate.com for enrollment information.
Where is the NCT05314491 trial being conducted?
This trial is being conducted at Guimarães, Portugal, Bratislava, Slovakia, Exeter, United Kingdom.
Who is sponsoring the NCT05314491 clinical trial?
NCT05314491 is sponsored by Limacorporate S.p.a. The trial plans to enroll 68 participants.