Evaluation of Multigen Plus CCK and AMF TT Cones in Knee Surgery
Official title: A Prospective, Post-marketing Study Evaluating Clinical and Radiographic Early Outcomes of Total Knee Arthroplasty With Multigen Plus CCK Alone or Involving the AMF TT Cones.
Run by Limacorporate S.p.a · NCT05314491 · Data updated 2026-11-12
This study is testing how well a new knee replacement device works for people with joint instability after surgery, comparing results with and without special support cones.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 68 (estimated) |
| Sponsor | Limacorporate S.p.a Industry-sponsored |
| Locations | 3 sites (Guimarães and 2 other locations) |
| Status | Recruiting |
| Started | June 21, 2022 |
| Main results expected | July 2026 |
| Study ends | July 2026 |
| Registry record updated | March 10, 2025 |
| Trial ID | NCT05314491 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who require Total Knee Arthroplasty with the Multigen Plus system due to joint instability or inadequate ligament function.
✕Probably not a fit
Patients under 18 years old or those with contraindications for the Multigen Plus system or AMF TT cones will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study evaluates the clinical and radiographic outcomes of 68 patients undergoing Total Knee Arthroplasty (TKA) using the Multigen Plus CCK prosthesis, with or without AMF TT cones, specifically for those with joint instability or inadequate ligament function. The study is multicentric and prospective, involving preoperative assessments and follow-up visits at 3 months, 12 months, and 2 years post-surgery. The decision to use the prosthesis is made independently by the investigators based on clinical practice, ensuring that the study's design does not influence surgical decisions.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes for patients undergoing knee arthroplasty, particularly those with complex cases.
How similar studies have gone: While this study builds on existing knowledge of knee arthroplasty, the specific use of the Multigen Plus CCK and AMF TT cones in this context is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
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
Study contacts
- Study coordinator: Francesca Citossi, CIS Manager Europe & APAC
- Email: francesca.citossi@limacorporate.com
- Phone: +39 335 1640260
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.