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Recruiting NCT04884542

Multigen Plus H Study and AMF TT Cones

— Observational Arthroplasty, Replacement, Knee

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Revision Total Knee Arthroplasty.
Who it may be relevant to
Registry conditions: Arthroplasty, Replacement, Knee. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium, Slovakia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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.

Overview

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.

Interventions

  • Device Revision Total Knee Arthroplasty
    Total Knee Arthroplasty in case of failure of a previous operation.

Primary outcome measures

  • Functional Knee Society Score (KSS) [Time frame: Month 24]
Secondary outcome measures (5)
  • KOOS-ADL (Function in Daily Living subdomain) [Time frame: Month 24]
  • VAS Pain score [Time frame: Month 24]
  • Survivorship of the implant [Time frame: Month 24]
  • Radiographic implant evaluation and stability assessment [Time frame: Month 24]
  • Safety evaluation [Time frame: Intra-operatively, Month 3, Month 12, and Month 24]

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 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Belgium · 1 center
  • AZ Jan Palfijn Gent — Ghent
Slovakia · 1 center
  • Nemocnica Bory - Penta Hospital — Bratislava

Identifiers

NCT: NCT04884542 · K-23

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗