Osteochondral Lesions of the Knee Joint study: SSOC
Official title MaioRegen Prime Study for the Treatment of Deep Osteochondral Lesion of the Knee
ClinicalTrials.gov ID: NCT07332182
What this study is testing
- What it's testing
- This study wants to find out if a new treatment called MaioRegen Prime is safer and more effective than standard surgery for deep knee cartilage injuries.
- Who it's for
- The study is looking for people with deep injuries to the cartilage in their knee joint.
- What's involved
- Participants will receive either the new gel treatment or standard surgery to clean out the damaged area. Doctors will check how well the knee is healing using physical exams and patient reports.
- Time commitment
- The source text does not specify the total duration of the study or the number of required visits.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- Informed consent prior to any study-related procedures;
- Male or female patients aged between 18 and 60 years (inclusive);
- Body Mass Index (BMI) ≤ 35;
- Up to 3 treatable osteochondral lesions localized in femoral condyles and/or trochlea (the patient might have other lesion in other parts of the...
- Knee osteochondral lesion(s) (Grade IVa and IVb according to ICRS Classification) or not re-fixable knee Osteochondritis Dissecans lesions as...
You likely can't join if
- IKDC subjective score at Baseline is more than or equal to 70;
- KOOS Pain Subscale score at baseline is less than 20 or more than 65 (scale: maximum pain = 0, pain free = 100);
- Osteochondral tibial plateau and/or patella defects;
- Patients affected by advanced osteoarthritis in the index knee (Kellgren and Lawrence classification 3 or 4);
- Bony defect depth deeper than 5 mm, according to baseline MRI, measured from the original subchondral bone plate level;
- Uncontained defects: lack of vital bone wall at least 2 mm thick, completely surrounding the lesion - based on MRI;
See the full eligibility criteria
Who can join
- Informed consent prior to any study-related procedures;
- Male or female patients aged between 18 and 60 years (inclusive);
- Body Mass Index (BMI) ≤ 35;
- Up to 3 treatable osteochondral lesions localized in femoral condyles and/or trochlea (the patient might have other lesion in other parts of the joint, but they should not be more severe than ICRS Grade II lesions as...
- Knee osteochondral lesion(s) (Grade IVa and IVb according to ICRS Classification) or not re-fixable knee Osteochondritis Dissecans lesions as determined by baseline MRI;
- Lesions with an overall treatable area 1-7 cm2 (as determined by baseline MRI). In case of multiple lesions (maximum 3 lesions) in the same knee compartment a minimum distance of 3 mm is required);
- IKDC Subjective score at baseline (pre-op evaluation) is less than 70;
- Non-responsive to physical therapy for at least 6 weeks;
- Patients physically and mentally willing and able to comply with the post-operative rehabilitation protocol and scheduled clinical and radiographic visits.
What rules you out
- IKDC subjective score at Baseline is more than or equal to 70;
- KOOS Pain Subscale score at baseline is less than 20 or more than 65 (scale: maximum pain = 0, pain free = 100);
- Osteochondral tibial plateau and/or patella defects;
- Patients affected by advanced osteoarthritis in the index knee (Kellgren and Lawrence classification 3 or 4);
- Bony defect depth deeper than 5 mm, according to baseline MRI, measured from the original subchondral bone plate level;
- Uncontained defects: lack of vital bone wall at least 2 mm thick, completely surrounding the lesion - based on MRI;
- Patients with untreated patellofemoral malalignment or who have undergone realignment procedures within 6 months;
- Patients with bone fracture or uncorrected malalignment more than 5 degrees varus or valgus according to standing X-ray.
- Patients previously treated for total or partial meniscectomy in the specific index knee compartments (more than 50% of the meniscus in the index compartments is missing);
- Patient requiring total or partial meniscectomy to be performed concomitantly, involving more than 50% of one or both menisci in the index knee compartment (lack of functional remaining meniscus, at least 5mm rim at the...
- Untreated knee ligament instability or treated within 6 months;
- Kissing (counterposed) osteochondral lesions;
- Significant instability of the index knee according to IKDC Knee Examination Form 2000: Grade C (abnormal) or D (severely abnormal).
- Patients affected by any concomitant painful or disabling disease of the spine, hips, or lower limbs, including the contralateral knee, that would interfere with the evaluation of the index knee;
- Patients affected by bilateral knee lesions that need treatment;
- Intra-articular steroid injections within 3 months;
- Any previous cartilage repair procedure (such as: microfracture, Osteochondral autograft transplantation system (OATS), Autologous Matrix Induced Chondrogenesis, (AMIC), Autologous Chondrocyte Implantation (ACI) with or...
- Patients affected by osteoporosis (established through x-ray tests, called DEXA scans, bone density, etc. Criteria for osteoporosis: T-score is \< - 2.5 SD), chondrodysplasia, or osteogenesis imperfecta;
- Patients affected by known allergy to equine collagen or calcium-phosphates;
- Patients who underwent chemotherapy in the past 12 months;
- Patients with a known history of any significant systemic disease (such as but not limited to: HIV, hepatitis, HTLV, syphilis, coagulopathies, insulin dependent diabetes mellitus etc.) or affected by a significant...
- Participation in other clinical trials within 90 days prior to the study or concurrent with the study;
- Patient who is pregnant (or intends to become pregnant within one-year post-op) or breastfeeding;
- Known drugs or alcohol abuse;
- Any evidence of active infection anywhere in the body. Urinary Tract Infection (UTI) patients can be included following antibiotic treatment, and provided that two consecutive cultures are negative (taken within at...
- Any known history of intra-articular or osseous infection of the index knee;
- Patients affected by a known history of inflammatory arthropathy or crystal-deposition arthropathy;
- Prisoners;
- The existence of any surgical or medical condition that, in the judgement of the Investigator, might compromise patient safety or the outcome of the study;
- Any medical conditions or implants that would prevent the participant from undergoing an MRI, including but not limited to pacemakers, clips, cochlear implants, or metal shrapnel.
The study team makes the final eligibility decision.
Where it is enrolling
- Steamboat Springs, Colorado, United States
- Oak Brook, Illinois, United States
- Ann Arbor, Michigan, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
- Portland, Oregon, United States
- Jackson, Tennessee, United States
- Rockwall, Texas, United States
- Bologna, BO, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Steamboat Springs, Colorado, United States; Oak Brook, Illinois, United States; Ann Arbor, Michigan, United States; Cincinnati, Ohio, United States; Columbus, Ohio, United States; Portland, Oregon, United States and 3 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.