Multigen Plus CCK and AMF TT Cones Follow Up Study

NCT05314491 | Recruiting FDA Device

• 1 other identifier: K-24
• Study Type: observational
• Target: 68
• Locations: 3 countries
• Sites: 3

Brief 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 primary and revision procedures.

Conditions

Total Knee Arthroplasty; Revision Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Knee Society Score (KSS)

  Functional changes in the Knee Society Score (KSS) from pre-operative (baseline) to 2 years after the surgery.

  Month 24

Secondary Outcomes (5)

• KOOS-ADL (Function in Daily Living subdomain)

  Month 24

• VISUAL ANALOGUE SCALE (VAS) PAIN

  Month 24

• Kaplan-Meier analysis

  Month 24

• Radiographic assessment

  Month 24

• Safety evaluation

  Intra-operatively, Month 3, Month 12, and Month 24

Study Arms (2)

Multigen Plus CCK

Device: Multigen Plus CCK

Multigen Plus CCK in combination with AMF TT cones

Device: Multigen Plus CCK; Device: AMF TT cones

Interventions

Multigen Plus CCK DEVICE

Total Knee Arthroplasty

Multigen Plus CCK; Multigen Plus CCK in combination with AMF TT cones

AMF TT cones DEVICE

To fill a proximal tibia or distal femur defect

Multigen Plus CCK in combination with AMF TT cones

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Limacorporate S.p.a: lead

Study Sites (3)

Hospital Senhora da Oliveira in Guimarães

Guimarães, Portugal

RECRUITING

Saints Cyril and Methodius Hospital

Bratislava, Slovakia

RECRUITING

Royal Devon and Exeter Hospital

Exeter, United Kingdom

RECRUITING

Central Study Contacts

Francesca Citossi, CIS Manager Europe & APAC

CONTACT

+39 335 1640260; francesca.citossi@limacorporate.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 6, 2022
• Study Start: June 21, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); SL (1); PT (1)