Hyalofast + Microfracture for Knee Cartilage Repair

(FastTRACK Trial)

Not currently recruiting at 48 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)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments for repairing cartilage issues in the knee. One group undergoes a procedure called microfracture, which aids healing by creating small holes in the bone to release healing cells. The other group uses a Hyalofast scaffold, a special material combined with bone marrow cells to repair the knee. Individuals with troublesome knee cartilage problems, confirmed by a doctor, and who have been managing pain with basic painkillers might be suitable candidates. As an unphased trial, this study provides patients the opportunity to explore innovative treatments for knee cartilage repair.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using Hyalofast with bone marrow aspirate concentrate (BMAC) is generally safe. Studies found its safety comparable to microfracture, a common surgical technique, indicating that the treatment is usually well-tolerated. Earlier studies did not identify any major safety issues, and patients often experienced improvements in knee cartilage health. Overall, Hyalofast appears to be a safe option for repairing knee cartilage. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Hyalofast with BMAC treatment for knee cartilage repair because it combines a hyaluronan-based scaffold with autologous bone marrow aspirate concentrate in a single procedure. This approach aims to enhance cartilage regeneration by providing a supportive structure for new cartilage growth while delivering stem cells and growth factors directly from the bone marrow. Unlike traditional microfracture techniques, which only involve creating small holes in the bone to release these elements, Hyalofast with BMAC offers a more targeted and potentially more efficient way to repair cartilage damage.

What evidence suggests that this trial's treatments could be effective for knee cartilage repair?

This trial will compare two treatments for knee cartilage repair: Hyalofast with bone marrow aspirate concentrate (BMAC) and Microfracture surgery. Studies have shown that Hyalofast with BMAC can lead to significant improvements. In one study, patients experienced less pain and better knee movement after treatment. Another study found that Hyalofast improved a knee health score from 40 to 83. Additionally, Hyalofast provided significant benefits for sports and recreational activities. These findings suggest that Hyalofast with BMAC might effectively treat knee cartilage problems. ^{1 2 3 4 5}

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

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 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]

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. sciencedirect.com sciencedirect.com/science/article/pii/S2773157X25002486

Repairing Knee Cartilage with Hyalofast: A Systematic ... In terms of primary outcomes, Gobbi's study revealed that repairs performed with BMAC in conjunction with Hyalofast tend to sustain or improve ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10145501/

Hyalofast Cartilage Repair Surgery with a Full Load ... Results: The clinical results demonstrated a statistically significant improvement in the number of complaints about pain and in the quality of ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02659215

HyaloFAST Trial for Repair of Articular Cartilage in the Knee The purpose of this study is to evaluate the safety and efficacy of Hyalofast® scaffold with bone marrow aspirate concentrate (BMAC) compared to microfracture.

4. ir.anika.com ir.anika.com/2025-07-30-Anika-Reports-Topline-Results-from-U-S-Pivotal-FastTRACK-Phase-III-Study-for-Hyalofast-R-Cartilage-Repair-Scaffold-and-Provides-Program-Update

Anika Reports Topline Results from U.S. Pivotal FastTRACK ... Hyalofast showed statistically significant improvements in key pre-defined secondary endpoints including KOOS Sports and Recreation Function, ...

5. biotechpromed.com biotechpromed.com/wp-content/uploads/2020/10/Hyalofast-biotech-2020.pdf

Hyalofast - One Step Cartilage Repair It readily adheres to the site of application without requiring additional . Hyalofast improved IKDC clinical score from 40 pre-op to 83 post-op.