Arthroplasty, Replacement, KneeNCT04884542
Multigen Plus H Study and AMF TT Cones
An observational study of Arthroplasty, Replacement, Knee, run by Limacorporate S.p.a at 2 sites in 2 countries.
Trial summary
The aim of this study is to assess the clinical, patient-reported, and radiographic outcomes of a revision Total Knee Arthroplasty with Multigen Plus H and AMF TT Cones. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- Revision Total Knee Arthroplasty
- Type of treatment
- Medical device
- How many people
- 43 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 19 Jan 2022to 30 Jun 2027
- 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 H 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 the Multigen Plus H system as per Indication For Use. The decision to implant a Multigen Plus H 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.
- Subject is able to comply with the 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 H, as reported in the current Instruction For Use.
- Any clinically significant pathology based on the medical history or any medical intervention 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
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Belgium1 site, 1 recruiting
- Recruiting
AZ Jan Palfijn Gent
Ghent, 9000
Wouter Van den Broecke, 09 224 71 11, info@janpalfingent.be
Wouter Van den Broecke
Slovakia1 site, 1 recruiting
- Not yet recruiting
Nemocnica Bory - Penta Hospital
Bratislava, 625J+3P
Libor Necas, +421 950105510
libor.necas@unm.sk
About this study
Official title: A Prospective, Post-marketing Study Evaluating Clinical and Radiographic Early Outcomes of Revision Total Knee Arthroplasty With Multigen Plus H Alone or Involving AMF TT Cones.
The aim of this study is to assess the clinical, patient-reported, and radiographic outcomes of a revision Total Knee Arthroplasty with Multigen Plus H and AMF TT Cones.
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- Revision Total Knee Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revision Total Knee ArthroplastyDevice
Total Knee Arthroplasty in case of failure of a previous operation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Knee Society Score (KSS)
Evaluation of the changes in the Functional Knee Society Score (KSS) after revision TKA
Measured: Month 24
Secondary outcomes (5)
KOOS-ADL (Function in Daily Living subdomain)
Evaluation of the functional changes in the KOOS-ADL domain after revision TKA
Measured: Month 24
VAS Pain score
Evaluation of the changes in the VAS Pain score after revision TKA
Measured: Month 24
Survivorship of the implant
Kaplan-Meier estimate
Measured: Month 24
Radiographic implant evaluation and stability assessment
Evaluation of progressive Radiolucent Lines after revision TKA
Measured: Month 24
Safety evaluation
Incidence, type, and severity of all the Adverse Events (AEs) occurred after revision TKA
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 posted13 May 2021
- Study start19 Jan 2022
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, KneeStudies 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
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Limacorporate S.p.a
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- North American Science Associates Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04884542
- Sponsor's protocol ID
- K-23
- Status last verified
- Mar 2025
- First submitted
- 7 May 2021
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- 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 Revision Total Knee Arthroplasty With Multigen Plus H Alone or Involving AMF TT Cones.
- ClinicalTrials.gov ID
- NCT04884542
- Acronym / sponsor ID
- K-23
- Conditions
- Arthroplasty, Replacement, Knee
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Limacorporate S.p.aIndustry (pharma, biotech, devices)
- Collaborators
- North American Science Associates Ltd.
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 13 May 2021 (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.
The aim of this study is to assess the clinical, patient-reported, and radiographic outcomes of a revision Total Knee Arthroplasty with Multigen Plus H and AMF TT Cones.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
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 H 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 the Multigen Plus H system as per Indication For Use. The decision to implant a Multigen Plus H 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.
- Subject is able to comply with the protocol
Key exclusion criteria (5 listed)
- Age \&lt; 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 H, as reported in the current Instruction For Use.
- Any clinically significant pathology based on the medical history or any medical intervention 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 |
|---|---|---|
| Revision Total Knee ArthroplastyTotal Knee Arthroplasty in case of failure of a previous operation. | Device | – |
Primary outcome
Functional Knee Society Score (KSS)
Time frame: Month 24
Evaluation of the changes in the Functional Knee Society Score (KSS) after revision TKA
5 secondary outcomes
KOOS-ADL (Function in Daily Living subdomain)
Time frame: Month 24
VAS Pain score
Time frame: Month 24
Survivorship of the implant
Time frame: Month 24
Radiographic implant evaluation and stability 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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasty, Replacement, Knee, run by Limacorporate S.p.a at 2 sites in 2 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 2 sites in Belgium, Slovakia. 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 (+39 335 164026, francesca.citossi@limacorporate.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional 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.