New knee cartilage repair method shows promise in clinical trial

NCT ID NCT02659215

Disease control Sponsor: Anika Therapeutics, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a special scaffold (Hyalofast) combined with the patient's own bone marrow cells can better repair knee cartilage damage than standard microfracture surgery. About 200 adults with knee cartilage defects will be randomly assigned to one of the two treatments. The goal is to see which approach provides better pain relief and knee function over two years.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

200 people

The number who actually took part.

Started

Dec 2015

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patient is male or female, between 18 and 60 years of age 2. Patient's body mass index (BMI) is \<35 kg/m2 3. 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 4. The symptomatic lesion is classified as International Cartilage Repair Society (ICRS) grade 3 or 4 5. Patient agrees to actively participate in a strict rehabilitation protocol and follow-up program 6. Patient is using only nonsteroidal anti-inflammatory drugs or acetaminophen/paracetamol during the month before signing the informed consent form to treat knee pain 7. Patient is willing and able to provide informed consent and comply with study requirements 8. 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 9. Patient has ability to consistently rate knee pain and function as demonstrated by completion of total KOOS score 10. 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 11. 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. 12. Patient is willing to restrict pain medication after 6 months post-surgery to NSAIDs or acetaminophen/paracetamol only through the end of the trial 13. 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: 1. 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). 2. 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. 3. Diagnosed advanced osteoarthritis as demonstrated by a Kellgren-Lawrence grade of 3 or 4 in the index knee 4. 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) 5. Infections or skin diseases at target knee joint 6. Osteochondritis dissecans (OCD) 7. Patients requiring meniscal arrow or meniscal sutures 8. Previous meniscal transplant in the index knee 9. Patients with previous total or functional meniscectomy. (Patients with a previous partial meniscectomy and a meniscus that is considered biomechanically functional are allowed) 10. Varus or valgus malalignment exceeding 10° in either knee 11. 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. 12. 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 13. Previous failed microfracture procedure in index knee. (Previous history of microfracture in the contralateral knee is allowed) 14. Known hypersensitivity (allergy) to hyaluronate 15. Contraindication(s) to microfracture surgery 16. Hyaluronic acid intra-articular injections into the index knee within the last 90 days before signing informed consent 17. 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. 18. Uncontrolled diabetes 19. 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 20. Any clinically significant or symptomatic vascular or neurologic disorder of the lower extremities 21. 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 22. Rheumatoid arthritis or gouty arthritis 23. Current diagnosis of osteomyelitis 24. 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. 25. 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 26. Alcohol and drug (including medication) abuse 27. 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) 28. Contraindications to MR imaging 29. Patient is currently receiving workman's compensation or disability or is in litigation for workman's compensation or disability claims 30. Participation in concurrent trials or in previous trial within 90 days of signing informed consent

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Conditions

The condition(s) this trial relates to.

articular cartilage disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Defect of articular cartilage

Contacts and locations

Locations

A.O. Universitaria San Martino Monoblocco

Genova, 16132, Italy
AB "Ortopedijos technika"

Kaunas, LT-49476, Lithuania
Austin Ortho Biologics / Seton Medical Center Austin

Austin, Texas, 78705, United States
Axis Clinical Trials

Los Angeles, California, 90036, United States
Baylor Scott & White

Temple, Texas, 76508, United States
BioSolutions Clinical Research Center

San Diego, California, 91942, United States
Bone and Joint Clinic of Baton Rouge

Baton Rouge, Louisiana, 70808, United States
Clinical Research Center of Nevada

Las Vegas, Nevada, 89121, United States
Covington Orthopedic and Sports Medicine Institute

Covington, Louisiana, 70433, United States
Cruz Roja Mexicana (Hospital de Ortopedia de la Cruz Roja Mexicana)

Mérida, CP 97166, Mexico
DE KK Ortopediai Klinika

Debrecen, Hungary
De La Salle Medical and Health Sciences Institute

Cavite, Philippines
Desarrollo Ético en Investigación Clínica S.C.

Guadalajara, CP 44500, Mexico
Epic Medical Research

Murray, Utah, 84123, United States
Evangelisches Krankenhaus

Vienna, 1180, Austria
Health Center of Downtown-Lipotvaros, Orthopedic Outpatient Clinic (Belvárosi-Lipótvárosi Egészségügyi Szolgálat Ortopeadia)

Budapest, 1051, Hungary
Hospital Universitario Dr. José Eleuterio González

Monterrey, Mexico
Instituto Ortopedico Rizzoli

Bologna, Italy
Jutrix Medical Llc

Budapest, 6000, Hungary
Kastelypark Klinka

Tata, Hungary
Kepler University Clinic

Linz, Upper Austria, 4021, Austria
Kerlan-Jobe Orthopedic Clinic

Los Angeles, California, 90045, United States
Krankenhaus der Barmherzigen Schwestern

Ried, Upper Austria, 4910, Austria
Magyar Honvedseg, Egeszseugyi Kozpont, Balesteti Sebeszeti Osztaly

Budapest, Hungary
Medical University of Graz

Graz, Austria
Medical University of Vienna

Vienna, 1090, Austria
Medistra Hospital

Jakarta, Indonesia
Menta Egeszsegkozpont Kft.

Budapest, H-1115, Hungary
New Hope Research Development

Tarzana, California, 91356, United States
New York Presbyterian Hospital

New York, New York, 11355, United States
North Estonia Medical Center

Tallinn, 13419, Estonia
Ohio State University Wexner Medical Center

Columbus, Ohio, 43221, United States
OrthoIllinois

Rockford, Illinois, 61107, United States
Orthopedic Foundation

Stamford, Connecticut, 06905, United States
Ortopeedia Arstid AS

Tallinn, 10138, Estonia
Paramount Trials, LLC

Miami, Florida, 33016, United States
Penn Medicine

Philadelphia, Pennsylvania, 19104, United States
Physicians Research Group

Tempe, Arizona, 85284, United States
Private Hospital Doebling

Vienna, 1190, Austria
Royal Progess Hospital

Jakarta, Indonesia
Semmelweis Egyetem Orthopaedic Clinic (Ortopédiai Klinika)

Budapest, 1113, Hungary
Somogy Megyei Kaposi Mór Oktatókórház

Kaposvár, Hungary
Suncoast Clinical Research

New Port Richey, Florida, 34652, United States
University Federico II

Naples, 80131, Italy
University Hospital Tulln

Tulln, Lower Austria, 3430, Austria
Universtitatsklinkik Krems

Krems, 3500, Austria
Uzsoki Hospital, Department of Traumatology

Budapest, 1145, Hungary
Vilnius University Hospital Santaros klinikos

Vilnius, LT-08661, Lithuania

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