NCT05314491

Multigen Plus CCK and AMF TT Cones Follow Up Study

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.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 68 (estimated)
• Sponsor: Limacorporate S.p.a · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Total Knee Arthroplasty
• Revision Total Knee Arthroplasty

Interventions

Type	Name	Description
DEVICE	Multigen Plus CCK	Total Knee Arthroplasty
DEVICE	AMF TT cones	To fill a proximal tibia or distal femur defect

Timeline

• Start date: 2022-06-21
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2022-04-06
• Last updated: 2025-03-10

Locations

3 sites across 3 countries: Portugal, Slovakia, United Kingdom

Regulatory

• FDA-regulated device study