Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsN/A

Multigen Plus CCK and AMF TT Cones Follow Up Study

Sponsor: Limacorporate S.p.a

NCT ID: NCT05314491

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Multigen Plus CCK (device), AMF TT cones (device)
How long the study runs
Study runs about 49 months (dates as stated)
About the drug or intervention
Multigen Plus CCK — device: Total Knee Arthroplasty · AMF TT cones — device: To fill a proximal tibia or distal femur defect
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
68
Started
2022-06-21
Last checked
2025-03

Plain English Summary

What is this study?

  • • Testing a new treatment for total knee arthroplasty
  • • Clinical study - 68 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with total knee arthroplasty

Where?

  • • Exeter - Royal Devon and Exeter Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Total Knee ArthroplastyRevision Total Knee Arthroplasty

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Male or female.
  • ✓Age ≥ 18 years old.
  • ✓Given written agreement to take part approved by the reference Ethics Committee (EC).
  • ✓Subjects able to comply with the Study Protocol.

Who cannot take part

  • ✗Age \< 18 years old.
  • ✗Any clinically significant pathology based on the medical history that the Investigator feels may affect the study...
  • ✗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...
See the full 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 Is This Study? (1 UK site)

Royal Devon and Exeter Hospital

Exeter, United Kingdom

Recruiting
Site contact (verified)
Jonathan PhillipsPrincipal Investigator

How to Get in Touch

Francesca Citossi, CIS Manager Europe & APAC

Sponsor contact

CONTACT

+39 335 1640260 francesca.citossi@limacorporate.com
Data sourced from ClinicalTrials.gov · Last verified: 2025-03