Actively Recruiting
Multigen Plus CCK and AMF TT Cones Follow Up Study
Led by Limacorporate S.p.a · Updated on 2025-03-10
68
Participants Needed
3
Research Sites
210 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Multigen Plus CCK and AMF TT Cones Follow Up Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Hospital Senhora da Oliveira in Guimarães
Guimarães, Portugal
Actively Recruiting
2
Saints Cyril and Methodius Hospital
Bratislava, Slovakia
Actively Recruiting
3
Royal Devon and Exeter Hospital
Exeter, United Kingdom
Actively Recruiting
Research Team
F
Francesca Citossi, CIS Manager Europe & APAC
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here