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Clinical Trials/NCT04884542
NCT04884542RecruitingNot Applicable

A Prospective, Post-marketing Study Evaluating Clinical and Radiographic Early Outcomes of Revision Total Knee Arthroplasty with Multigen Plus H Alone or Involving AMF TT Cones.

Limacorporate S.p.a2 sites in 2 countries43 target enrollmentStarted: January 19, 2022Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
43
Locations
2
Primary Endpoint
Functional Knee Society Score (KSS)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Functional Knee Society Score (KSS)

Time Frame: Month 24

Evaluation of the changes in the Functional Knee Society Score (KSS) after revision TKA

Secondary Outcomes

  • Radiographic implant evaluation and stability assessment(Month 24)
  • KOOS-ADL (Function in Daily Living subdomain)(Month 24)
  • Safety evaluation(Intra-operatively, Month 3, Month 12, and Month 24)
  • VAS Pain score(Month 24)
  • Survivorship of the implant(Month 24)

Investigators

Sponsor
Limacorporate S.p.a
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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