MaioRegen Prime for Knee Cartilage Damage
(OSTEOCONFIRM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called MaioRegen Prime, a regenerative therapy for individuals with serious cartilage damage in their knees. Researchers aim to determine if MaioRegen Prime is more effective and safer than the current standard treatment, which involves cleaning out damaged tissue. The study seeks participants with knee joint damage that hasn't improved after at least six weeks of physical therapy. Participants must be willing to follow a rehabilitation plan and attend follow-up visits. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatment options.
What prior data suggests that the MaioRegen Prime device is safe for treating knee cartilage damage?
A previous study found that patients who received MaioRegen Prime implants generally tolerated the treatment well, with no serious side effects directly linked to the implant. Some patients might experience mild discomfort or swelling after the procedure, but these effects are common with many knee treatments and usually resolve on their own.
MaioRegen Prime is a medical device under investigation for knee cartilage damage, and all medical treatments carry some risks. However, current research suggests that this treatment is safe for most participants.12345Why do researchers think this study treatment might be promising?
MaioRegen Prime is unique because it uses a specially designed implant to repair knee cartilage damage, offering a regenerative approach rather than just symptomatic relief. Unlike the standard treatment options like debridement, which simply cleans out damaged tissue, MaioRegen Prime aims to promote natural cartilage regrowth. Researchers are excited about this treatment because it has the potential to restore knee function more effectively and sustainably than current surgical methods.
What evidence suggests that the MaioRegen Prime device is effective for knee cartilage damage?
Studies have shown that MaioRegen Prime, which participants in this trial may receive, can greatly improve knee function for individuals with bone and cartilage damage in their knees. Research indicates that 92% of patients treated with this method report good-to-excellent results. Specifically, one year after treatment, 80% of patients had normal or nearly normal knee function. Long-term evidence also suggests positive outcomes, with improvements lasting up to 10 years. This treatment appears promising for aiding recovery from deep knee damage.678910
Are You a Good Fit for This Trial?
This trial is for adults aged 18-60 with significant knee cartilage and bone damage (deep osteochondral lesions) who haven't improved after at least 6 weeks of physical therapy. Participants must have a BMI of 35 or less, up to three treatable lesions in specific parts of the knee, and be able to follow rehab instructions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo either MaioRegen Prime implant or debridement surgery
Post-operative Follow-up
Participants are monitored through clinical, subjective, and objective assessments at specified intervals
Long-term Follow-up
Annual follow-up visits post-24 months to monitor long-term outcomes
What Are the Treatments Tested in This Trial?
Interventions
- MaioRegen Prime
Trial Overview
The study compares two treatments for deep knee cartilage and bone injuries: an implant called MaioRegen Prime versus standard care involving cleaning out damaged tissue (debridement). Patients are assessed using both clinical exams and their own reports on symptoms.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Medical Device: MaioRegen Prime implant
Debridement
Find a Clinic Near You
Who Is Running the Clinical Trial?
Fin-Ceramica Faenza Spa
Lead Sponsor
Citations
MaioRegen Prime Osteochondral Scaffold Specs | PDF
Supporting clinical evidence comes from studies showing significant improvement in knee function scores up to 10 years post-surgery.
2.
researchgate.net
researchgate.net/publication/26627822_Treatment_of_osteochondral_defects_of_the_knee(PDF) Treatment of osteochondral defects of the knee
Recent clinical data indicate that functional outcome … good-to-excellent results were achieved in 92% of the patients treated on 61 patients ...
3.
springermedicine.com
springermedicine.com/magnetic-resonance-imaging/magnetic-resonance-imaging/autologous-minced-cartilage-repair-for-chondral-and-osteochondra/25968774Autologous minced cartilage repair for chondral and ...
NAS knee function improved from a median of 7 (range: 2–10) to 3 (0–7) after five years, respectively. Satisfactory Lysholm (76.5 ± 12.5), IKDC ...
ORS 2024 Annual Meeting Paper No. 1603
The knee that increasing defect size led to a significant increase in contact pressures on the MFC and LFC, with the highest pressures observed near the 3 mm ...
MaioRegen Prime Study for the Treatment of… (NCT07332182)
The present study aims to compare the efficacy and the safety of MaioRegen Prime to Debridement (SSOC) in patients with deep osteochondral lesions of the knee ...
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