Multigen Plus CCK and AMF TT Cones Follow Up Study

June 15, 2023 updated by: Limacorporate S.p.a

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

68

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

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 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Multigen Plus CCK
Device: Multigen Plus CCK
Total Knee Arthroplasty
Multigen Plus CCK in combination with AMF TT cones
Device: Multigen Plus CCK
Total Knee Arthroplasty
Device: AMF TT cones
To fill a proximal tibia or distal femur defect

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Month 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
KOOS-ADL (Function in Daily Living subdomain)
Time Frame: Month 24
Functional changes in the KOOS-ADL (Function in Daily Living subdomain) at 2 years after the surgery.
Month 24
Kaplan-Meier analysis
Time Frame: Month 24
Survival rate of the implant (Kaplan-Meier estimate) at 2 years after the surgery.
Month 24
Radiographic assessment
Time Frame: Month 24
Radiographic implant evaluation and stability assessment at 2 years after the surgery.
Month 24
VISUAL ANALOGUE SCALE (VAS) PAIN
Time Frame: Month 24
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.
Month 24
Safety evaluation
Time Frame: Intra-operatively, Month 3, Month 12, and Month 24
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
Intra-operatively, Month 3, Month 12, and Month 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Limacorporate S.p.a

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2022

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

March 30, 2022

First Submitted That Met QC Criteria

March 30, 2022

First Posted (Actual)

April 6, 2022

Study Record Updates

Last Update Posted (Estimated)

June 16, 2023

Last Update Submitted That Met QC Criteria

June 15, 2023

Last Verified

July 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • K-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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