Assessing outcomes of knee replacement using Multigen Plus H and AMF TT Cones

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Tau changes after hip or knee replacement surgery

  Researchers will see if brain tau changes after hip or knee surgery and whether these changes relate to inflammation and thinking abilities.

  Recruiting Uppsala University Hospital · Uppsala · NCT07871487

• Ultrasound predictors of adductor canal block success after knee replacement

  This study tests whether ultrasound factors can predict how well an adductor canal block will relieve pain after total knee arthroplasty in adults.

  Recruiting Konya City Hospital · Konya, Konya · NCT07730216

• Rebound Pain After Knee Replacement: Does It Link to Long-Term Pain?

  This study tests whether rebound pain after a nerve block during knee replacement is linked to developing chronic pain later on.

  Recruiting Konya City Hospital · Konya, Meram · NCT07511985

• Comparing BiFeS and iPACK nerve blocks for pain after knee replacement

  This trial will test if adding the BiFeS nerve block to an adductor canal block controls pain and reduces opioid use more than adding the iPACK block in people having total knee replacement.

  Recruiting Amasya University · Amasya · NCT07360392

• Chlorhexidine antimicrobial incise drape for hip and knee replacement surgery

  This will test a chlorhexidine antimicrobial incise drape to see if it reduces contamination during primary hip or knee replacement surgery.

  Recruiting at 2 sites Solventum US LLC · Fishers, Indiana and 1 other locations · NCT07356323

• Different doses of corticosteroid in local knee injection for total knee replacement

  This will test whether adding different doses of Diprospan to the local pain injection given during primary unilateral total knee replacement reduces postoperative pain and improves early recovery.

  Recruiting First Affiliated Hospital of Fujian Medical University · Fuzhou, Fujian · NCT07337772

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.