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
Qualifiers
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 design
Treatments tested in this trial
- Revision Total Knee Arthroplasty
Treatment groups
No treatment groups listed
Sponsors and collaborators
Limacorporate S.p.a
Lead sponsor
North American Science Associates Ltd.
Collaborator
Source ClinicalTrials.gov