Multigen Plus H Study and AMF TT Cones
ConditionArthroplasty, Replacement, Knee
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLimacorporate S.p.a
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
The subject population for this study includes adult subjects in whom the decision to perform a Total Knee Arthroplasty with Multigen Plus H 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Revision Total Knee Arthroplasty
DeviceTotal Knee Arthroplasty in case of failure of a previous operation.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Functional Knee Society Score (KSS)
Evaluation of the changes in the Functional Knee Society Score (KSS) after revision TKA
Time frame
Month 24Secondary outcomes
1
KOOS-ADL (Function in Daily Living subdomain)
Evaluation of the functional changes in the KOOS-ADL domain after revision TKA
Time frame
Month 242
VAS Pain score
Evaluation of the changes in the VAS Pain score after revision TKA
Time frame
Month 243
Survivorship of the implant
Kaplan-Meier estimate
Time frame
Month 244
Radiographic implant evaluation and stability assessment
Evaluation of progressive Radiolucent Lines after revision TKA
Time frame
Month 24Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Limacorporate S.p.a
Lead sponsor
North American Science Associates Ltd.
Collaborator
Source ClinicalTrials.gov