Active — Not RecruitingNot Applicable

HyaloFAST Trial for Repair of Articular Cartilage in the Knee

United States200 participantsStarted 2015-12

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

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

Timeframe: 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

Timeframe: 2 years post-surgery

Trial details

NCT IDNCT02659215

SponsorAnika Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03-20

View on ClinicalTrials.gov More Defect of Articular Cartilage trials

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

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

Timeframe: 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

Timeframe: 2 years post-surgery