CompletedNot Applicable

Multicenter Perspective Study: Clinical Evaluation of the Persona MC® With Preservation or Sacrifice of the PCL

Italy7 participantsStarted 2019-12-20

Plain-language summary

Prospective, multicenter study on the Total Knee Prosthesis available on the market "Persona Medial Congruent® knee". Primary endpoint -Evaluation of the survival of the implant after 5 years of follow-up Secondary endpoints * Evaluation of the survival of the implant at 10 years of follow up. * Evaluation of clinical and radiographic outcomes in Italian patients undergoing total knee replacement with the Persona Medial Congruent® implant with sacrifice or retention of the posterior cruciate ligament (PCL)

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis
. Collagen disorders and/or avascular necrosis of the femoral condyle
. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
. Moderate valgus, varus, or flexion deformities
. The salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Evaluate the safety based on implant survivorship at 5 years follow up

Timeframe: 72 months

Trial details

NCT IDNCT04244929

SponsorIstituto Ortopedico Rizzoli

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12-20

View on ClinicalTrials.gov More Prosthesis Survival trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis
. Collagen disorders and/or avascular necrosis of the femoral condyle
. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
. Moderate valgus, varus, or flexion deformities
. The salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee