BridgeMD
New treatment option for Chondral Defect
Official title A Study of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee
ClinicalTrials.gov ID: NCT03588975
What this study is testing
What is MACI?
MACI is an investigational medicine, being studied as a potential treatment for chondral defect.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The objective of this study is to compare the efficacy and safety of MACI® vs arthroscopic microfracture in the treatment of participants aged 10 to 17 years with symptomatic articular chondral or osteochondral defects of the knee.
- Phase 3: a large, late-stage study
- 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 10 to 17
You may be able to join if
- Symptomatic cartilage or osteochondral defects
- One or more International Cartilage Repair Society (ICRS) Grade III or IV chondral or unsalvageable osteochondral defects located on the femoral...
- Concurrent ICRS Grade I and II defects are acceptable on the tibia if they remain untreated (or are treated with debridement only) at the time of...
- Participants with a potentially re-attachable osteochondral fragment, identified by magnetic resonance imaging (MRI) and that has not previously been...
You likely can't join if
- apply, the participant may continue in the PEAK study: a MACI biopsy will be taken, the participant will be assigned by chance and treated per...
- At least 1 defect size ≥1.5 cm2 on the patella, femoral condyles and/or the trochlea; defects include OCD lesions with a bone lesion depth of ≤6 mm...
- Salvageable OCD lesions must have failed prior conservative and a reparative treatment, and the participant still experiences pain associated with...
- Stable target knee (i.e., anterior and posterior cruciate ligaments should be free of laxity as well as stable and intact). Ligament repair or...
- Intact meniscus or partial meniscus (at least 50% of functional meniscus remaining) in the target knee. Meniscal repair or resection might be...
- Written informed consent Exclusion Criteria:
See the full eligibility criteria
- Symptomatic cartilage or osteochondral defects
- One or more International Cartilage Repair Society (ICRS) Grade III or IV chondral or unsalvageable osteochondral defects located on the femoral condyles and/or trochlea amenable to treatment with the surgical procedure...
- Concurrent ICRS Grade I and II defects are acceptable on the tibia if they remain untreated (or are treated with debridement only) at the time of study treatment.
- Participants with a potentially re-attachable osteochondral fragment, identified by magnetic resonance imaging (MRI) and that has not previously been repaired, may be consented to the study and undergo baseline...
- apply, the participant may continue in the PEAK study: a MACI biopsy will be taken, the participant will be assigned by chance and treated per protocol.
- At least 1 defect size ≥1.5 cm2 on the patella, femoral condyles and/or the trochlea; defects include OCD lesions with a bone lesion depth of ≤6 mm and does not require a bone graft.
- Salvageable OCD lesions must have failed prior conservative and a reparative treatment, and the participant still experiences pain associated with the osteochondral lesion. Participants with defects as a result of...
- Stable target knee (i.e., anterior and posterior cruciate ligaments should be free of laxity as well as stable and intact). Ligament repair or reconstruction procedures are allowed prior to screening arthroscopy.
- Intact meniscus or partial meniscus (at least 50% of functional meniscus remaining) in the target knee. Meniscal repair or resection might be performed either staged or concurrent with the cartilage repair procedure...
- Written informed consent Exclusion Criteria:
- Any surgery on the target knee joint within 6 months prior to Screening (not including diagnostic arthroscopy)
- Previous investigational drug or device use within 3 months prior to Screening
- Avascular necrosis of the target knee (other than potential OCD lesion to be treated)
- Participants with uninvolved open growth plates where the surgery necessitates crossing the growth plate, or where the depth of the lesion crosses the growth plate
- ICRS Grade III or IV chondral or unsalvageable osteochondral defects located on the tibia or any lesion that is bipolar to the index lesion
- Malalignment requiring concurrent osteotomy to correct tibial-femoral or patella-femoral alignment (prior guided growth treatment is not exclusionary)
- Symptomatic musculoskeletal conditions in the lower limbs that could impede measurement of how well it works for the target knee joint
- Concomitant inflammatory disease or other conditions that affects the joints (eg, rheumatoid arthritis, metabolic bone disease, psoriasis, symptomatic chondrocalcinosis)
- Known history of septic arthritis in the index knee joint
- Current malignancy or treatment for malignancy within the past 5 years
- Known history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin
- Females who are pregnant or lactating
- Participants who, in the opinion of the Investigator, have significant medical or psychosocial problems that warrant exclusion. Examples of significant problems included but are not limited to:
- Any condition that has potential for negatively impacting intra or postoperative course
- Conditions that limit compliance with rehabilitation program
- Any condition that has potential for significantly limiting participant's ability to assess postoperative knee function
- Any condition, psychiatric or otherwise, that would preclude informed consent/assent, consistent follow-up, or compliance with any aspect of the study
- Participant is currently abusing drugs or alcohol or, in the opinion of the Investigator, at high risk for poor compliance
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
- Sacramento, California, United States
- New Orleans, Louisiana, United States
- Baltimore, Maryland, United States
- Ann Arbor, Michigan, United States
- Akron, Ohio, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
- Milwaukee, Wisconsin, United States
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 - 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, 10 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States; Sacramento, California, United States; New Orleans, Louisiana, United States; Baltimore, Maryland, United States; Ann Arbor, Michigan, United States; Akron, Ohio, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.