Multigen Plus CCK and AMF TT Cones Follow Up Study
Recruiting
Observational Study
Total Knee ArthroplastyRevision Total Knee Arthroplasty
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
68 (estimated)
Sponsor
Limacorporate S.p.a · Industry
Who this trial is looking for
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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.
Trial Locations
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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…
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.
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