HyaloFAST Trial for Repair of Articular Cartilage in the Knee

NCT02659215 | Active Not Recruiting DMC

• 1 other identifier: Hyalofast 15-01
• Study Type: interventional
• Target: 200
• Locations: 9 countries
• Sites: 48

Brief 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.

Conditions

Defect of Articular Cartilage

Keywords

Hyaluronic Acid; Cartilage Repair; Knee

Outcome Measures

Primary Outcomes (2)

• 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

  2 years post-surgery

• 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

  2 years post-surgery

Secondary Outcomes (5)

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

  2 years post-surgery

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

  2 years post-surgery

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

  2 years post-surgery

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

  2 years post-surgery

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

  3 years post-surgery

Study Arms (2)

Hyalofast with BMAC

EXPERIMENTAL

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

Device: Hyalofast

Microfracture

ACTIVE COMPARATOR

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.

Procedure: Microfracture

Interventions

Microfracture PROCEDURE

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

Microfracture

Hyalofast DEVICE

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

Hyalofast with BMAC

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Anika Therapeutics, Inc.: lead

Study Sites (48)

Physicians Research Group

Tempe, Arizona, 85284, United States

Location

Axis Clinical Trials

Los Angeles, California, 90036, United States

Location

Kerlan-Jobe Orthopedic Clinic

Los Angeles, California, 90045, United States

Location

BioSolutions Clinical Research Center

San Diego, California, 91942, United States

Location

New Hope Research Development

Tarzana, California, 91356, United States

Location

Orthopedic Foundation

Stamford, Connecticut, 06905, United States

Location

Paramount Trials, LLC

Miami, Florida, 33016, United States

Location

Suncoast Clinical Research

New Port Richey, Florida, 34652, United States

Location

OrthoIllinois

Rockford, Illinois, 61107, United States

Location

Bone and Joint Clinic of Baton Rouge

Baton Rouge, Louisiana, 70808, United States

Location

Covington Orthopedic and Sports Medicine Institute

Covington, Louisiana, 70433, United States

Location

Clinical Research Center of Nevada

Las Vegas, Nevada, 89121, United States

Location

New York Presbyterian Hospital

New York, New York, 11355, United States

Location

Ohio State University Wexner Medical Center

Columbus, Ohio, 43221, United States

Location

Penn Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Austin Ortho Biologics / Seton Medical Center Austin

Austin, Texas, 78705, United States

Location

Baylor Scott & White

Temple, Texas, 76508, United States

Location

Epic Medical Research

Murray, Utah, 84123, United States

Location

University Hospital Tulln

Tulln, Lower Austria, 3430, Austria

Location

Kepler University Clinic

Linz, Upper Austria, 4021, Austria

Location

Krankenhaus der Barmherzigen Schwestern

Ried, Upper Austria, 4910, Austria

Location

Medical University of Graz

Graz, Austria

Location

Universtitatsklinkik Krems

Krems, 3500, Austria

Location

Medical University of Vienna

Vienna, 1090, Austria

Location

Evangelisches Krankenhaus

Vienna, 1180, Austria

Location

Private Hospital Doebling

Vienna, 1190, Austria

Location

Ortopeedia Arstid AS

Tallinn, 10138, Estonia

Location

North Estonia Medical Center

Tallinn, 13419, Estonia

Location

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

Budapest, 1051, Hungary

Location

Semmelweis Egyetem Orthopaedic Clinic (Ortopédiai Klinika)

Budapest, 1113, Hungary

Location

Uzsoki Hospital, Department of Traumatology

Budapest, 1145, Hungary

Location

Jutrix Medical Llc

Budapest, 6000, Hungary

Location

Menta Egeszsegkozpont Kft.

Budapest, H-1115, Hungary

Location

Magyar Honvedseg, Egeszseugyi Kozpont, Balesteti Sebeszeti Osztaly

Budapest, Hungary

Location

DE KK Ortopediai Klinika

Debrecen, Hungary

Location

Somogy Megyei Kaposi Mór Oktatókórház

Kaposvár, Hungary

Location

Kastelypark Klinka

Tata, Hungary

Location

Medistra Hospital

Jakarta, Indonesia

Location

Royal Progess Hospital

Jakarta, Indonesia

Location

Instituto Ortopedico Rizzoli

Bologna, Italy

Location

A.O. Universitaria San Martino Monoblocco

Genova, 16132, Italy

Location

University Federico II

Naples, 80131, Italy

Location

AB "Ortopedijos technika"

Kaunas, LT-49476, Lithuania

Location

Vilnius University Hospital Santaros klinikos

Vilnius, LT-08661, Lithuania

Location

Desarrollo Ético en Investigación Clínica S.C.

Guadalajara, CP 44500, Mexico

Location

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

Mérida, CP 97166, Mexico

Location

Hospital Universitario Dr. José Eleuterio González

Monterrey, Mexico

Location

De La Salle Medical and Health Sciences Institute

Cavite, Philippines

Location

Related Publications (1)

• 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.

  PMID: 33512974 DERIVED

MeSH Terms

Interventions

Arthroplasty, Subchondral

Intervention Hierarchy (Ancestors)

Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• Alberto Gobbi, MD

  OASI Bioresearch Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2016
• First Posted: January 20, 2016
• Study Start: December 1, 2015
• Primary Completion: March 20, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (18); PH (1); ME (3); AU (8); IT (3); LI (2); ES (2); HU (9); ID (2)