Assessing outcomes of knee replacement using Multigen Plus H and AMF TT Cones
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.
This study is testing how well a specific knee replacement system works for people who need a revision surgery and what their experiences are after the procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 43 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Limacorporate S.p.a Industry-sponsored |
| Locations | 2 sites (Ghent and 1 other locations) |
| Trial ID | NCT04884542 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the clinical, patient-reported, and radiographic outcomes following revision Total Knee Arthroplasty using the Multigen Plus H system and AMF TT Cones. Participants will be individuals who have already been determined to require this specific knee replacement procedure. The study will gather data on various outcomes to better understand the effectiveness and safety of these interventions in a real-world clinical setting.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are scheduled for a Total Knee Arthroplasty using the Multigen Plus H system.
Not a fit: Patients under 18 years old or those with contraindications for the Multigen Plus H system or AMF TT Cones will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the understanding of knee replacement outcomes, leading to enhanced patient care and surgical techniques.
How similar studies have performed: While this specific approach may not have been extensively tested, similar studies evaluating knee arthroplasty outcomes have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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 \&lt; 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.
Where this trial is running
Ghent and 1 other locations
- AZ Jan Palfijn Gent — Ghent, Belgium (Recruiting)
- Nemocnica Bory - Penta Hospital — Bratislava, Slovakia (Not_yet_recruiting)
Study contacts
- Study coordinator: Francesca Citossi
- Email: francesca.citossi@limacorporate.com
- Phone: +39 335 164026
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.