Evaluation of Multigen Plus CCK and AMF TT Cones in Knee Surgery

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 testing how well a new knee replacement device works for people with joint instability after surgery, comparing results with and without special support cones.

Quick facts

• Study type: Observational
• Enrollment: 68 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Limacorporate S.p.a (industry)
• Locations: 3 sites (Guimarães and 2 other locations)
• Trial ID: NCT05314491 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the clinical and radiographic outcomes of 68 patients undergoing Total Knee Arthroplasty (TKA) using the Multigen Plus CCK prosthesis, with or without AMF TT cones, specifically for those with joint instability or inadequate ligament function. The study is multicentric and prospective, involving preoperative assessments and follow-up visits at 3 months, 12 months, and 2 years post-surgery. The decision to use the prosthesis is made independently by the investigators based on clinical practice, ensuring that the study's design does not influence surgical decisions.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who require Total Knee Arthroplasty with the Multigen Plus system due to joint instability or inadequate ligament function.

Not a fit: Patients under 18 years old or those with contraindications for the Multigen Plus system or AMF TT cones will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve surgical outcomes for patients undergoing knee arthroplasty, particularly those with complex cases.

How similar studies have performed: While this study builds on existing knowledge of knee arthroplasty, the specific use of the Multigen Plus CCK and AMF TT cones in this context is relatively novel.

Eligibility criteria

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.

Where this trial is running

Guimarães and 2 other locations

• 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)

Study contacts

• Study coordinator: Francesca Citossi, CIS Manager Europe & APAC

Conditions: Total Knee Arthroplasty, Revision Total Knee Arthroplasty