Hyalofast + Microfracture for Knee Cartilage Repair
(FastTRACK Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment for knee cartilage damage using a special pad and concentrated bone marrow cells from the patient. It aims to help patients whose knee cartilage causes symptoms and may not respond to usual treatments. The pad supports the bone marrow cells to heal and regenerate the damaged area. Bone marrow concentrate (BMC) has shown promise in treating knee issues and cartilage repair due to its regenerative potential.
Will I have to stop taking my current medications?
The trial requires that you only use nonsteroidal anti-inflammatory drugs (NSAIDs) or acetaminophen/paracetamol for knee pain before joining. After surgery, you must avoid NSAIDs for 6 months and can use other pain medications like acetaminophen or prescribed narcotics. After 6 months, you can only use NSAIDs or acetaminophen for pain.
Is Hyalofast with Microfracture safe for knee cartilage repair?
How is the treatment Hyalofast + Microfracture unique for knee cartilage repair?
Hyalofast combined with microfracture is unique because it uses a minimally invasive approach to enhance cartilage repair by applying a hyaluronan-based scaffold (a supportive structure) after creating small holes in the bone to stimulate healing. This combination aims to improve the quality and organization of the new cartilage compared to microfracture alone.12467
What data supports the effectiveness of the treatment Hyalofast + Microfracture for knee cartilage repair?
Research shows that microfracture, a technique used to repair knee cartilage, improves knee function in 70% to 90% of patients, especially in the first year after surgery. Combining microfracture with Hyalofast, a new treatment method, is being explored for its potential to enhance cartilage repair.168910
Who Is on the Research Team?
Alberto Gobbi, MD
Principal Investigator
OASI Bioresearch Foundation
Are You a Good Fit for This Trial?
Adults aged 18-60 with a BMI under 35 and knee pain from cartilage damage in the femoral condyle or trochlea, sized 1.5 - 6 cm2, graded ICRS 3 or 4. Participants must be able to follow a strict rehab protocol, not use certain pain meds for six months post-surgery except NSAIDs or acetaminophen, and meet specific health criteria like normal blood counts.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo either Hyalofast® with BMAC or Microfracture procedure for knee cartilage repair
Rehabilitation
Participants follow a strict post-surgery rehabilitation protocol specific to the defect location
Follow-up
Participants are monitored for safety and effectiveness after treatment with assessments at multiple intervals
What Are the Treatments Tested in This Trial?
Interventions
- Hyalofast
- Microfracture
Find a Clinic Near You
Who Is Running the Clinical Trial?
Anika Therapeutics, Inc.
Lead Sponsor