AzTrials
AzTrials

Defect of Articular CartilageFastTRACKNCT02659215

HyaloFAST Trial for Repair of Articular Cartilage in the Knee

A study testing Hyalofast and Microfracture in people with Defect of Articular Cartilage, run by Anika Therapeutics, Inc. at 48 sites in 9 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the safety and efficacy of Hyalofast® scaffold with bone marrow aspirate concentrate (BMAC) compared to microfracture in the treatment of symptomatic cartilage defects of the knee. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Defect of Articular Cartilage
What is being tested?
Hyalofast and Microfracture
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
48 sitesin 9 countries
Study dates
Dec 2015to 30 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patient is male or female, between 18 and 60 years of age
  • Patient's body mass index (BMI) is <35 kg/m2
  • Patient has a symptomatic lesion of the femoral condyle (medial and/or lateral) or femoral trochlea that is between 1.5 - 6 cm2 on screening images confirmed by the independent radiologist
  • The symptomatic lesion is classified as International Cartilage Repair Society (ICRS) grade 3 or 4
  • Patient agrees to actively participate in a strict rehabilitation protocol and follow-up program
  • Patient is using only nonsteroidal anti-inflammatory drugs or acetaminophen/paracetamol during the month before signing the informed consent form to treat knee pain
Show all 13Show fewer
  • Patient is willing and able to provide informed consent and comply with study requirements
  • Patient, if woman of childbearing potential, must have a negative pregnancy test at Screening, cannot be lactating and is willing to use adequate contraception for the first 12 months of the study after the last surgery
  • Patient has ability to consistently rate knee pain and function as demonstrated by completion of total KOOS score
  • Patient has a minimum of 45 out of 100 Visual Analogue Scale (VAS) score for index knee pain when remembering index knee pain when not on medication and when active
  • Patient is willing to use other pain medication rather than Non-steroidal Anti-inflammatory Drugs (NSAIDS) for 6 months post-surgery (e.g. acetaminophen, or narcotic analgesics, if prescribed). Post-surgical use of aspirin for clot prevention is acceptable.
  • Patient is willing to restrict pain medication after 6 months post-surgery to NSAIDs or acetaminophen/paracetamol only through the end of the trial
  • 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

Who cannot join

  • Major concomitant cartilage lesions which require extensive surgical treatment. (Lesions such as minor loose bodies, small debris fragments, small cartilage fragments or prominent knee fat pad are allowed. These lesions may be treated with debridement).
  • Presence of a kissing bipolar lesion that is apposed to the index lesion and is deeper than Grade 2 (ICRS classification) as determined by MRI. (Presence of a kissing (bipolar) lesion that is apposed to the index lesion and is deeper than Grade 2 and is discovered under arthroscopy are allowed). The non-index lesion, if indicated for treatment, should be treated with the study assigned treatment of the index lesion.
  • Diagnosed advanced osteoarthritis as demonstrated by a Kellgren-Lawrence grade of 3 or 4 in the index knee
  • Complex ligamentous instability of the index or contralateral knee. (Previous reconstructions of Anterior Cruciate Ligament (ACL) or Posterior Cruciate Ligament (PCL) are allowed, of either the index or contralateral knee, if instability is not present. Grade 1 ligamentous injury are allowed)
  • Infections or skin diseases at target knee joint
  • Osteochondritis dissecans (OCD)
Show all 30Show fewer
  • Patients requiring meniscal arrow or meniscal sutures
  • Previous meniscal transplant in the index knee
  • Patients with previous total or functional meniscectomy. (Patients with a previous partial meniscectomy and a meniscus that is considered biomechanically functional are allowed)
  • Varus or valgus malalignment exceeding 10° in either knee
  • Patient requiring concomitant surgical procedures at the time of Index Procedure such as osteotomies (e.g. high tibial valgus and/or patellar realignment osteotomy), bone subchondral perforation, ligament surgery, meniscal surgeries etc.
  • Previous cartilage repair procedure (microfracture, Osteochondral autograft transplantation system (OATS) or Autologous Chondrocyte Implantation (ACI) with or without use of a scaffold (matrix) in the index knee
  • Previous failed microfracture procedure in index knee. (Previous history of microfracture in the contralateral knee is allowed)
  • Known hypersensitivity (allergy) to hyaluronate
  • Contraindication(s) to microfracture surgery
  • Hyaluronic acid intra-articular injections into the index knee within the last 90 days before signing informed consent
  • Corticosteroid therapy by systemic or intra-articular route within the last 60 days before informed consent or intramuscular or oral corticosteroids within the last 30 days before informed consent.
  • Uncontrolled diabetes
  • Any concomitant painful or disabling disease of the spine, hips, or lower limbs, including the contralateral knee, that would interfere with evaluation of the index knee
  • Any clinically significant or symptomatic vascular or neurologic disorder of the lower extremities
  • Any evidence of the following diseases in the index knee: septic arthritis; inflammatory joint disease; gout; recurrent episodes of pseudogout; Paget disease of bone; ochronosis; acromegaly; hemochromatosis; Wilson disease; primary osteochondromatosis; heritable disorders; collagen gene mutations
  • Rheumatoid arthritis or gouty arthritis
  • Current diagnosis of osteomyelitis
  • Any result from screening blood work (including complete blood count, Prothrombin Time (PT)/Partial Thromboplastin Time (PTT)/INR, liver function, and creatinine) that exceeds 1.5x the upper limit of normal or is below 0.5x the lower limit of normal.
  • Diagnosed musculoskeletal cancer or any diagnosed cancer, other than musculoskeletal if not on long term remission (e.g. at least 5 years or negative biopsy at last exam), except basal cell carcinoma
  • Alcohol and drug (including medication) abuse
  • Patients who are at higher risk for post-surgical bleeding (e.g., bleeding disorder; taking anticoagulants except low dose aspirin) or post-surgical infection (e.g., taking immunosuppressants; have a severe infection or a history of serious infection)
  • Contraindications to MR imaging
  • Patient is currently receiving workman's compensation or disability or is in litigation for workman's compensation or disability claims
  • Participation in concurrent trials or in previous trial within 90 days of signing informed consent

Trial locations and contacts

48 sites in 9 countries.

48 sites in 9 countries

United States18 sites

  • Austin Ortho Biologics / Seton Medical Center Austin

    Austin, Texas, 78705

  • Bone and Joint Clinic of Baton Rouge

    Baton Rouge, Louisiana, 70808

  • Ohio State University Wexner Medical Center

    Columbus, Ohio, 43221

  • Covington Orthopedic and Sports Medicine Institute

    Covington, Louisiana, 70433

  • Clinical Research Center of Nevada

    Las Vegas, Nevada, 89121

  • Axis Clinical Trials

    Los Angeles, California, 90036

  • Kerlan-Jobe Orthopedic Clinic

    Los Angeles, California, 90045

  • Paramount Trials, LLC

    Miami, Florida, 33016

  • Epic Medical Research

    Murray, Utah, 84123

  • Suncoast Clinical Research

    New Port Richey, Florida, 34652

  • New York Presbyterian Hospital

    New York, New York, 11355

  • Penn Medicine

    Philadelphia, Pennsylvania, 19104

  • OrthoIllinois

    Rockford, Illinois, 61107

  • BioSolutions Clinical Research Center

    San Diego, California, 91942

  • Orthopedic Foundation

    Stamford, Connecticut, 06905

  • New Hope Research Development

    Tarzana, California, 91356

  • Physicians Research Group

    Tempe, Arizona, 85284

  • Baylor Scott & White

    Temple, Texas, 76508

Other trials in United States

Hungary9 sites

  • Health Center of Downtown-Lipotvaros, Orthopedic Outpatient Clinic (Belvárosi-Lipótvárosi Egészségügyi Szolgálat Ortopeadia)

    Budapest, 1051

  • Semmelweis Egyetem Orthopaedic Clinic (Ortopédiai Klinika)

    Budapest, 1113

  • Uzsoki Hospital, Department of Traumatology

    Budapest, 1145

  • Jutrix Medical Llc

    Budapest, 6000

  • Menta Egeszsegkozpont Kft.

    Budapest, H-1115

  • Magyar Honvedseg, Egeszseugyi Kozpont, Balesteti Sebeszeti Osztaly

    Budapest

  • DE KK Ortopediai Klinika

    Debrecen

  • Somogy Megyei Kaposi Mór Oktatókórház

    Kaposvár

  • Kastelypark Klinka

    Tata

Other trials in Hungary

Austria8 sites

  • Medical University of Graz

    Graz

  • Universtitatsklinkik Krems

    Krems, 3500

  • Kepler University Clinic

    Linz, Upper Austria, 4021

  • Krankenhaus der Barmherzigen Schwestern

    Ried, Upper Austria, 4910

  • University Hospital Tulln

    Tulln, Lower Austria, 3430

  • Medical University of Vienna

    Vienna, 1090

  • Evangelisches Krankenhaus

    Vienna, 1180

  • Private Hospital Doebling

    Vienna, 1190

Other trials in Austria

Italy3 sites

  • Instituto Ortopedico Rizzoli

    Bologna

  • A.O. Universitaria San Martino Monoblocco

    Genova, 16132

  • University Federico II

    Naples, 80131

Other trials in Italy

Mexico3 sites

  • Desarrollo Ético en Investigación Clínica S.C.

    Guadalajara, CP 44500

  • Cruz Roja Mexicana (Hospital de Ortopedia de la Cruz Roja Mexicana)

    Mérida, CP 97166

  • Hospital Universitario Dr. José Eleuterio González

    Monterrey

Other trials in Mexico

Estonia2 sites

  • Ortopeedia Arstid AS

    Tallinn, 10138

  • North Estonia Medical Center

    Tallinn, 13419

Other trials in Estonia

Indonesia2 sites

  • Medistra Hospital

    Jakarta

  • Royal Progess Hospital

    Jakarta

Other trials in Indonesia

Lithuania2 sites

  • AB "Ortopedijos technika"

    Kaunas, LT-49476

  • Vilnius University Hospital Santaros klinikos

    Vilnius, LT-08661

Other trials in Lithuania

Philippines1 site

  • De La Salle Medical and Health Sciences Institute

    Cavite

Other trials in Philippines

About this study

Official title: A Prospective, Randomized, Active Treatment-controlled, Evaluator-blinded Multicenter Study to Establish the Superiority of Hyalofast® With BMAC in the Treatment of Articular Knee Cartilage Defect Lesions in Comparison to Control

The purpose of this study is to evaluate the safety and efficacy of Hyalofast® scaffold with bone marrow aspirate concentrate (BMAC) compared to microfracture in the treatment of symptomatic cartilage defects of the knee.

Read the detailed description
  • Prospective, randomized, active treatment-controlled, evaluator-blinded (radiologist reviewer and physician evaluator) multicenter study (up to 40 sites in the US and EU).
  • All subjects that meet preoperative screening eligibility criteria will be randomized to treatment with Hyalofast® with BMAC or Microfracture.
  • Hyalofast® is a sterile, biodegradable non-woven pad (2 x 2 cm or 5 x 5 cm) that is composed of HYAFF-11®, a benzyl ester of hyaluronic acid. Hyalofast® acts as a biodegradable support for the autologous bone marrow aspirate concentrate. Hyalofast® is soft and conformable and can easily be cut to fit the lesion size.
  • Autologous bone marrow is harvested from the subject intraoperatively during the Index Procedure. Approximately 60 mL of bone marrow will be aspirated from the subject's iliac crest using the SmartPrep 2 Bone Marrow Processing Pack. The cellular rich portion will be concentrated via the SmartPrep BMAC 2 Centrifuge System at point-of-care to provide 7 mL of bone marrow aspirate concentrate (BMAC). 1 - 2 mLs will be used for post-procedure testing of total nucleated cells, cell viability, and sterility.
  • Hyalofast® with BMAC is implanted during either a standard knee arthroscopy or min-arthrotomy depending upon surgeon preferences and intra-operative findings. The lesion to be treated will be debrided to a stable cartilage margin. The defect will be sized and Hyalofast® will be cut to fit the lesion area. If necessary, more than one Hyalofast® pad can be overlapped to cover the lesion. 2 mL of BMAC will be loaded per Hyalofast® scaffold and then implanted to cover the defect. Hyalofast® with BMAC readily adheres to the site of application, but, if necessary, can be secured to the defect margins with an FDA-approved fibrin glue.
  • All subjects will be assessed at intervals post-procedure (1 month, 3 months, 6 months, 12 months, 24 months, and 36 months).
  • Subjects will be required to follow a strict pre-specified post-surgery rehabilitation protocol specific to the defect location.
  • Measures to assess effectiveness will be conducted at follow-ups, with the primary effectiveness endpoint assessment done at the 24 month timepoint.
  • Evaluators doing efficacy assessments of the subject and administering subject-reported outcome instruments will be blinded to the treatment.
  • Safety will be assessed by the collection of adverse events at all timepoints.
  • Magnetic Resonance Imaging (MRI) will be conducted at Screening, 1 month, 12 months, 24 months, and 36 months. Evaluation of the MRIs, including the Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score, will be done by blinded radiologist reviewers. The one month MRI will be used as the baseline MRI for evaluation of treatment effectiveness.
Being tested
Hyalofast, Microfracture
Keywords
Hyaluronic Acid, Cartilage Repair, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HyalofastDevice

    Implantation of Hyalofast scaffold with autologous bone marrow aspirate concentrate via arthroscopy/mini-arthrotomy.

  • MicrofractureProcedure or surgery

    Microfracture is a well-established arthroscopic surgical technique for cartilage repair which involves several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect, with resultant complete defect fill by a well-anchored clot

Study groups in NCT02659215
Study groupRoleWhat they receive
Hyalofast with BMACExperimentalA hyaluronan-based scaffold (Hyalofast®) is utilized together with autologous bone marrow aspirate concentrate (BMAC) in a one-step arthroscopic/mini-arthrotomic procedure.
Receives: Device: Hyalofast
MicrofractureActive comparatorMicrofracture 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.
Receives: Procedure: Microfracture

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Superiority of Hyalofast with Bone Marrow Aspirate Concentrate (BMAC) vs. Microfracture for % Change in Knee injury and Osteoarthritis Outcome Score (KOOS) Pain Score

    Co-primary endpoint

    Measured: 2 years post-surgery

  2. Superiority of Hyalofast with Bone Marrow Aspirate Concentrate (BMAC) vs. Microfracture for % Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score

    Co-Primary Endpoint

    Measured: 2 years post-surgery

Secondary outcomes (5)

  1. Superiority of Hyalofast® with autologous BMAC vs. Microfracture for change in MRI MOCART Score from baseline to two years post-surgery

    Measured: 2 years post-surgery

  2. Superiority of Hyalofast® with autologous BMAC vs. Microfracture for change in Evaluator Global Assessment from baseline to two years post-surgery

    Measured: 2 years post-surgery

  3. Superiority of Hyalofast® with autologous BMAC vs. Microfracture in change in individual KOOS subscales from baseline to two years post-surgery

    Measured: 2 years post-surgery

  4. Superiority of Hyalofast® with autologous BMAC vs. Microfracture in change in IKDC Knee Examination Form domains from baseline to two years post-surgery

    Measured: 2 years post-surgery

  5. The incidence, timing, severity, and relationship to treatment of all Adverse Events (AE), will be collected for all participants.

    Measured: 3 years post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2016 (estimated)
  2. Study startDec 2015
  3. Primary completion20 Mar 2025
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02659215
Sponsor's protocol ID
Hyalofast 15-01
Acronym
FastTRACK
Status last verified
Apr 2026
First submitted
14 Jan 2016
Last updated
15 Apr 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Shah SS, Lee S, Mithoefer K. Next-Generation Marrow Stimulation Technology for Cartilage Repair: Basic Science to Clinical Application. JBJS Rev. 2021 Jan 19;9(1):e20.00090. doi: 10.2106/JBJS.RVW.20.00090.

    PubMed 33512974

Questions about this trial

What is this clinical trial studying?

A study testing Hyalofast and Microfracture in people with Defect of Articular Cartilage, run by Anika Therapeutics, Inc. at 48 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in United States, Hungary, Austria, Italy, Mexico and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Superiority of Hyalofast with Bone Marrow Aspirate Concentrate (BMAC) vs. Microfracture for % Change in Knee injury and Osteoarthritis Outcome Score (KOOS) Pain Score (time frame: 2 years post-surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02659215, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in