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RecruitingNCT04884542Updated Mar 10, 2025

Multigen Plus H Study and AMF TT Cones

An observational study in Arthroplasty, Replacement, Knee, sponsored by Limacorporate S.p.a. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-10.

Sponsored by Limacorporate S.p.a (part of Enovis) · Observational

From the registry’s dates

  • Started Jan 2022; still recruiting 4 years 9 months later.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
43
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Arthroplasty, Replacement, Knee
03

In context

Lead sponsor

Limacorporate S.p.a is the lead sponsor of 31 studies on the registry; 12 are open to participants now.

First submitted before Limacorporate S.p.a became part of Enovis.

Browse Limacorporate S.p.a studies →All Enovis studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or female
  • Age ≥ 18 years old
  • Given written 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

Exclusion criteria

Exclusion Criteria:

  • Age \< 18 years old
  • Subjects with any Multigen Plus system 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 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
43 participants (estimated)
Patient registry
No

Interventions

  • DeviceRevision Total Knee Arthroplasty

    Total Knee Arthroplasty in case of failure of a previous operation.

06

What researchers measure

Primary outcomes

  1. Functional Knee Society Score (KSS)

    Evaluation of the changes in the Functional Knee Society Score (KSS) after revision TKA

    Time frame: Month 24

Secondary outcomes

  1. KOOS-ADL (Function in Daily Living subdomain)

    Evaluation of the functional changes in the KOOS-ADL domain after revision TKA

    Time frame: Month 24

  2. VAS Pain score

    Evaluation of the changes in the VAS Pain score after revision TKA

    Time frame: Month 24

  3. Survivorship of the implant

    Kaplan-Meier estimate

    Time frame: Month 24

  4. Radiographic implant evaluation and stability assessment

    Evaluation of progressive Radiolucent Lines after revision TKA

    Time frame: Month 24

  5. Safety evaluation

    Incidence, type, and severity of all the Adverse Events (AEs) occurred after revision TKA

    Time frame: Intra-operatively, Month 3, Month 12, and Month 24

07

Study locations

1 of 2 sites recruiting
  • AZ Jan Palfijn Gent
    Gand, 9000, Belgium
    Recruiting
    • Wouter Van den Broecke · Contactinfo@janpalfingent.be · 09 224 71 11
    • Wouter Van den Broecke · Principal investigator
  • Nemocnica Bory - Penta Hospital
    Bratislava, 625J+3P, Slovakia
    Not yet recruiting
    • Libor Necas · Contact+421 950105510
    • · Contactlibor.necas@unm.sk
    • Libor Necas · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2022 (actual). Primary completion is estimated for Jun 2027, 65 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 7, 2021
First posted
May 13, 2021
StartActual
Jan 19, 2022
Primary completionEst.
Jun 30, 2027
CompletionEst.
Jun 30, 2027
Last update
Mar 10, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04884542
Lead sponsor
Limacorporate S.p.a
Collaborators
North American Science Associates Ltd.
Responsible party
Sponsor
First posted
May 13, 2021
Start date
Jan 19, 2022
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Mar 10, 2025

Study contacts

Francesca Citossi
Contact
francesca.citossi@limacorporate.com
+39 335 164026
Magalì Mafucci
Contact
magali.mafucci@limacorporate.com
+39 3316082095

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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