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Multigen Plus CCK and AMF TT Cones Follow Up Study

ConditionsTotal Knee ArthroplastyRevision Total Knee Arthroplasty
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLimacorporate S.p.a

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

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 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.

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 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.

Trial population

The subject population for this study includes adult subjects in whom the decision to perform a Total Knee Arthroplasty with Multigen Plus CCK 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

  • Multigen Plus CCK

    Device

    Total Knee Arthroplasty

  • AMF TT cones

    Device

    To fill a proximal tibia or distal femur defect

Treatment groups

68 Participants
are divided into 2 treatment groups
Group A: Multigen Plus CCK1 intervention
Group B: Multigen Plus CCK in combination with AMF TT cones2 interventions

Trial outcomes

Primary outcomes

1

Knee Society Score (KSS)

Functional changes in the Knee Society Score (KSS) from pre-operative (baseline) to 2 years after the surgery.

Time frame
Month 24

Secondary outcomes

1

KOOS-ADL (Function in Daily Living subdomain)

Functional changes in the KOOS-ADL (Function in Daily Living subdomain) at 2 years after the surgery.

Time frame
Month 24
2

VISUAL ANALOGUE SCALE (VAS) PAIN

Changes in the VAS Pain score from pre-operative (baseline) to 2 years after the surgery. Scale is from 0 to 10, where 0 means NO PAIN and 10 VERY SEVERE PAIN.

Time frame
Month 24
3

Kaplan-Meier analysis

Survival rate of the implant (Kaplan-Meier estimate) at 2 years after the surgery.

Time frame
Month 24
4

Radiographic assessment

Radiographic implant evaluation and stability assessment at 2 years after the surgery.

Time frame
Month 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Limacorporate S.p.a

Lead sponsor

Source ClinicalTrials.gov
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