Multigen Plus H Study and AMF TT Cones

Limacorporate

Status: Enrolling

Conditions: Arthroplasty, Replacement, Knee

Treatments: Device: Revision Total Knee Arthroplasty

Study type: Observational

Funder types: NETWORK; Industry

Identifiers

NCT04884542

K-23

Details and patient eligibility

About

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.

Enrollment: 43 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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

• 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 H, as reported in the current Instruction For Use.
• Any clinically significant 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.