Total Knee ArthroplastyNCT05314491
Multigen Plus CCK and AMF TT Cones Follow Up Study
An observational study of Total Knee Arthroplasty and Revision Total Knee Arthroplasty, run by Limacorporate S.p.a at 3 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty, Revision Total Knee Arthroplasty
- What is being tested?
- Multigen Plus CCK and AMF TT cones
- Type of treatment
- Medical device
- How many people
- 68 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 21 Jun 2022to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The subject population for this study includes adult subjects in whom the decision to perform a Total Knee Arthroplasty with Multigen Plus CCK system, alone or involving the AMF TT cones, must be taken prior to, and independently from, the decision to include the subject into the study.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Francesca Citossi, CIS Manager Europe & APAC contact
3 sites in 3 countries
Portugal1 site, 1 recruiting
- Recruiting
Hospital Senhora da Oliveira in Guimarães
Guimarães
Ms Daniela Batista, Daniela Batista <daniela.batista@blueclinical.pt>
Carlos Vilela
Slovakia1 site, 1 recruiting
- Recruiting
Saints Cyril and Methodius Hospital
Bratislava
Boris Šteňo, steno@pe.unb.sk
Boris Šteňo
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Devon and Exeter Hospital
Exeter
Sadie Heddon, sadie.heddon@nhs.net
Jonathan Phillips
About this study
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.
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.
Read the detailed description
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.
- Being tested
- Multigen Plus CCK, AMF TT cones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multigen Plus CCKDevice
Total Knee Arthroplasty
AMF TT conesDevice
To fill a proximal tibia or distal femur defect
| Study group | Role | What they receive |
|---|---|---|
| Multigen Plus CCK | Not described Receives: Device: Multigen Plus CCK | |
| Multigen Plus CCK in combination with AMF TT cones | Not described Receives: Device: Multigen Plus CCK; Device: AMF TT cones |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Society Score (KSS)
Functional changes in the Knee Society Score (KSS) from pre-operative (baseline) to 2 years after the surgery.
Measured: Month 24
Secondary outcomes (5)
KOOS-ADL (Function in Daily Living subdomain)
Functional changes in the KOOS-ADL (Function in Daily Living subdomain) at 2 years after the surgery.
Measured: Month 24
VISUAL ANALOGUE SCALE (VAS) PAIN
Changes in the VAS Pain score from pre-operative (baseline) to 2 years after the surgery. Scale is from 0 to 10, where 0 means NO PAIN and 10 VERY SEVERE PAIN.
Measured: Month 24
Kaplan-Meier analysis
Survival rate of the implant (Kaplan-Meier estimate) at 2 years after the surgery.
Measured: Month 24
Radiographic assessment
Radiographic implant evaluation and stability assessment at 2 years after the surgery.
Measured: Month 24
Safety evaluation
Incidence, type, and severity of all the Device Deficiency (DD), Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs), and Serious Adverse Device Effects (SADEs) occurred at each follow-up
Measured: Intra-operatively, Month 3, Month 12, and Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start21 Jun 2022
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Limacorporate S.p.a
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314491
- Sponsor's protocol ID
- K-24
- Status last verified
- Mar 2025
- First submitted
- 30 Mar 2022
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05314491
- Acronym / sponsor ID
- K-24
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Limacorporate S.p.aIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 6 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multigen Plus CCK | – | Device: Multigen Plus CCK |
| Multigen Plus CCK in combination with AMF TT cones | – | Device: Multigen Plus CCK, Device: AMF TT cones |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subject population for this study includes adult subjects in whom the decision to perform a Total Knee Arthroplasty with Multigen Plus CCK system, alone or involving the AMF TT cones, must be taken prior to, and independently from, the decision to include the subject into the study.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multigen Plus CCKTotal Knee Arthroplasty | Device | Multigen Plus CCK, Multigen Plus CCK in combination with AMF TT cones |
| AMF TT conesTo fill a proximal tibia or distal femur defect | Device | Multigen Plus CCK in combination with AMF TT cones |
Primary outcome
Knee Society Score (KSS)
Time frame: Month 24
Functional changes in the Knee Society Score (KSS) from pre-operative (baseline) to 2 years after the surgery.
5 secondary outcomes
KOOS-ADL (Function in Daily Living subdomain)
Time frame: Month 24
VISUAL ANALOGUE SCALE (VAS) PAIN
Time frame: Month 24
Kaplan-Meier analysis
Time frame: Month 24
Radiographic assessment
Time frame: Month 24
Safety evaluation
Time frame: Intra-operatively, Month 3, Month 12, and Month 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francesca Citossi, CIS Manager Europe & APAC contact
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Knee Arthroplasty and Revision Total Knee Arthroplasty, run by Limacorporate S.p.a at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Portugal, Slovakia, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesca Citossi, CIS Manager Europe & APAC (+39 335 1640260, francesca.citossi@limacorporate.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Society Score (KSS) (time frame: Month 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.