Hyalofast + Microfracture for Knee Cartilage Repair

(FastTRACK Trial)

Recruiting at 47 trial locations

Overseen By Brett Robin, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Anika Therapeutics, Inc.

Must be taking: NSAIDs, Acetaminophen

Must not be taking: Corticosteroids, Hyaluronic acid

Disqualifiers: Advanced osteoarthritis, Uncontrolled diabetes, Rheumatoid arthritis, Alcohol and drug abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 1 day (procedure)

200 Participants Needed

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?

Hyalofast combined with microfracture is generally considered safe for treating knee cartilage defects, with the most common complication being postoperative stiffness in a small percentage of patients (3.9%). ^{1 2 3 4 5}

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. ^{1 2 4 6 7}

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. ^{1 6 8 9 10}

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

My knee pain scores at least 45 out of 100 when active and not on medication.

Patient's body mass index (BMI) is <35 kg/m2

Patient must have Hematocrit ≥ 28.0%; White Blood Cell count ≤ 14,000; Platelet Count ≥ 50,000; Creatinine ≤ 2.0 mg/dL; and International Normalized Ratio (INR) ≤ 1.6

Exclusion Criteria

I need additional surgeries like bone or ligament surgery at the time of my main procedure.

I've had a previous cartilage repair in my knee.

I had a microfracture procedure in my knee that didn't work.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo either Hyalofast® with BMAC or Microfracture procedure for knee cartilage repair

1 day (procedure)

1 visit (in-person)

Rehabilitation

Participants follow a strict post-surgery rehabilitation protocol specific to the defect location

Up to 36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment with assessments at multiple intervals

36 months

6 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Hyalofast
• Microfracture

Trial Overview The trial is testing Hyalofast scaffold with bone marrow aspirate concentrate (BMAC) against microfracture surgery for treating knee cartilage defects. It aims to see which method is safer and more effective at relieving symptoms and repairing the damaged area.

How Is the Trial Designed?

Group I: Hyalofast with BMAC Experimental Treatment 1 Intervention

A hyaluronan-based scaffold (Hyalofast®) is utilized together with autologous bone marrow aspirate concentrate (BMAC) in a one-step arthroscopic/mini-arthrotomic procedure.

Group II: Microfracture Active Control 1 Intervention

Microfracture is an arthroscopic surgical technique involving placement of microfracture penetrations within the cartilage defect to provide stem cells and growth factors from the bone marrow to aid cartilage repair.

Who Is Running the Clinical Trial?

Anika Therapeutics, Inc.

Lead Sponsor

Trials

19

Recruited

3,100+

Published Research Related to This Trial

Microfracture surgery for knee cartilage repair led to significant functional improvement in 67% of patients after at least two years, with better outcomes linked to good repair-tissue fill and lower body-mass index.

Patients with a body-mass index over 30 kg/m² experienced worse results, and those with symptoms lasting less than twelve months before surgery had more frequent improvements in daily activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The microfracture technique for the treatment of articular cartilage lesions in the knee. A prospective cohort study. Mithoefer, K., Williams, RJ., Warren, RF., et al.[2022]

Enhanced microfracture procedures for treating focal cartilage injuries in the knee significantly improve patient-reported outcomes, indicating effectiveness in symptom relief, based on a review of 10 studies with 331 patients.

However, imaging results were inconsistent, and the reporting of treatment-related adverse events was inadequate, suggesting that while the procedure shows promise, further research is needed to fully endorse its use for grade III/IV cartilage lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced microfracture using acellular scaffolds improves results after treatment of symptomatic focal grade III/IV knee cartilage lesions but current clinical evidence does not allow unequivocal recommendation. da Cunha, CB., Andrade, R., Veloso, TR., et al.[2021]

Microfracture is an effective single-stage procedure for treating small cartilage defects, showing improvement in knee function for 70% to 90% of patients, especially in the first year after surgery.

The technique is cost-effective and has low patient morbidity, making it a valuable first-line treatment option, although outcomes may decline after one year, particularly in patients with a high body mass index or incomplete fibrocartilage fill.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microfracture: indications, technique, and results. Williams, RJ., Harnly, HW.[2022]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Biological resurfacing of grade IV articular cartilage ulcers in knee joint with Hyalofast. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

The microfracture technique for the treatment of articular cartilage lesions in the knee. A prospective cohort study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Arthroscopic Matrix-Assisted Autologous Chondrocyte Transplantation Versus Microfracture: A 6-Year Follow-up of a Prospective Randomized Trial. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

Enhanced microfracture using acellular scaffolds improves results after treatment of symptomatic focal grade III/IV knee cartilage lesions but current clinical evidence does not allow unequivocal recommendation. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Microfracture: indications, technique, and results. [2022]

6. France pubmed.ncbi.nlm.nih.gov

The effect of hyaluronan combined with microfracture on the treatment of chondral defects: an experimental study in a rabbit model. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Can Biologic Augmentation Improve Clinical Outcomes Following Microfracture for Symptomatic Cartilage Defects of the Knee? A Systematic Review. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Microsphere-based gradient implants for osteochondral regeneration: a long-term study in sheep. [2018]

9. Germany pubmed.ncbi.nlm.nih.gov

Microfracture versus Enhanced Microfracture Techniques in Knee Cartilage Restoration: A Systematic Review and Meta-Analysis. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Matrix-Augmented Bone Marrow Stimulation With a Polyglycolic Acid Membrane With Hyaluronan vs Microfracture in Local Cartilage Defects of the Femoral Condyles: A Multicenter Randomized Controlled Trial. [2022]