Status:
RECRUITING
Multigen Plus H Study and AMF TT Cones
Lead Sponsor:
Limacorporate S.p.a
Collaborating Sponsors:
North American Science Associates Ltd.
Conditions:
Arthroplasty, Replacement, Knee
Eligibility:
All Genders
18+ years
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 19 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT04884542
Start Date
January 19 2022
End Date
June 30 2027
Last Update
March 10 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
AZ Jan Palfijn Gent
Ghent, Belgium, 9000
2
Nemocnica Bory - Penta Hospital
Bratislava, Slovakia, 625J+3P