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Scaffold
Hyalofast + Microfracture for Knee Cartilage Repair (FastTRACK Trial)
N/A
Waitlist Available
Led By Alberto Gobbi, MD
Research Sponsored by Anika Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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 male or female, between 18 and 60 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years post-surgery
Awards & highlights
FastTRACK Trial Summary
This trial will compare the safety and effectiveness of a new scaffold combined with bone marrow cells to a current treatment for repairing damaged cartilage in the knee.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include discomfort at the site where bone marrow is taken (for BMAC), reaction to materials used in scaffolds, surgical risks like infection or bleeding, joint stiffness or swelling after treatment, and general anesthesia risks.
FastTRACK Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My knee pain scores at least 45 out of 100 when active and not on medication.
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I am between 18 and 60 years old.
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I have a painful knee lesion confirmed by a radiologist to be 1.5 - 6 cm2 in size.
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I agree to only use NSAIDs or acetaminophen for pain after 6 months post-surgery until the trial ends.
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My cartilage damage is severe.
FastTRACK Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years post-surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years post-surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Superiority of Hyalofast with Bone Marrow Aspirate Concentrate (BMAC) vs. Microfracture for % Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score
Superiority of Hyalofast with Bone Marrow Aspirate Concentrate (BMAC) vs. Microfracture for % Change in Knee injury and Osteoarthritis Outcome Score (KOOS) Pain Score
Secondary outcome measures
Superiority of Hyalofast® with autologous BMAC vs. Microfracture for change in Evaluator Global Assessment from baseline to two years post-surgery
Superiority of Hyalofast® with autologous BMAC vs. Microfracture for change in MRI MOCART Score from baseline to two years post-surgery
Knee
+2 moreFastTRACK Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Hyalofast with BMACExperimental Treatment1 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: MicrofractureActive Control1 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.
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Who is running the clinical trial?
Anika Therapeutics, Inc.Lead Sponsor
17 Previous Clinical Trials
2,722 Total Patients Enrolled
13 Trials studying Osteoarthritis
2,562 Patients Enrolled for Osteoarthritis
Alberto Gobbi, MDPrincipal InvestigatorOASI Bioresearch Foundation
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.My knee pain scores at least 45 out of 100 when active and not on medication.I have had a meniscal transplant in my knee before.I have a serious nerve or blood vessel problem in my legs that affects my daily life.My knee condition is not caused by infections, inflammation, genetic disorders, or specific diseases like gout or Paget's.I have rheumatoid arthritis or gout.I am not pregnant, not breastfeeding, and will use birth control for 12 months post-surgery.I don't need major surgery for knee cartilage issues, but minor ones are okay.My MRI shows a deep lesion near another affected area in my joint.My knee arthritis is severe, as shown by a high grade on a specific scale.I have had ACL or PCL knee surgery but do not currently have knee instability.My target knee is free from infections or skin diseases.I have been diagnosed with a bone infection.I cannot have microfracture surgery due to health reasons.I have been diagnosed with osteochondritis dissecans.I am willing to avoid NSAIDs and use other pain medications for 6 months after surgery.I haven't taken any corticosteroids by injection or orally in the last 30 to 60 days.I don't have any painful conditions in my spine, hips, or legs that would affect my knee's evaluation.I have musculoskeletal cancer or another type of cancer not in long-term remission.I have not had hyaluronic acid injections in my knee in the last 3 months.I am at high risk for bleeding or infection after surgery due to a condition or medication.I am between 18 and 60 years old.I have a painful knee lesion confirmed by a radiologist to be 1.5 - 6 cm2 in size.I agree to follow a strict rehabilitation and follow-up program.I've only used over-the-counter pain relievers for my knee pain in the last month.I am not pregnant, not breastfeeding, and will use birth control for 12 months post-surgery.I can regularly assess and report my knee pain and function.I agree to only use NSAIDs or acetaminophen for pain after 6 months post-surgery until the trial ends.My diabetes is not under control.I am willing to avoid NSAIDs and use other pain medications for 6 months after surgery.My knee is significantly bent inward or outward.I have had a complete or functional removal of my meniscus.My cartilage damage is severe.I need surgery for a torn meniscus using stitches or arrows.
Research Study Groups:
This trial has the following groups:- Group 1: Hyalofast with BMAC
- Group 2: Microfracture
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who qualifies as a viable candidate for this research endeavor?
"Participants eligible for this research must be aged between 18 and 60, have a BMI of less than 35kg/m2, demonstrate the capacity to rate their knee pain accurately via completion of total KOOS score, present with femoral condyle or trochlea lesion sized 1.5-6cm2 on screening images verified by an independent radiologist, experience at least 45 out of 100 Visual Analogue Scale (VAS) points when recalling index knee pain without medication and during activity as well as not being pregnant or lactating whilst using appropriate contraception over 12 months post last surgery. 200 individuals suffering from chondromalacia"
Answered by AI
Is enrollment currently open for this research trial?
"Affirmative. Clinicaltrials.gov lists this trial as actively recruiting with a start date of December 1st 2015 and most recent update on August 11th 2022. Two hundred people are needed from 6 different locations to take part in the study."
Answered by AI
How wide-spread is the availability of this trial?
"Currently, this study is being conducted at 6 sites located in Stamford, Austin and Rockford as well as other cities. If you decide to participate, it would be most beneficial for your convenience to select the clinic closest to you in order to reduce travel strain."
Answered by AI
What is the current participation rate for this experiment?
"This research demands 200 voluntary participants that meet the relevant inclusion criteria. Volunteers can be seen at Orthopedic Foundation in Stamford, Connecticut and Austin Ortho Biologics / Seton Medical Center Austin in Texas."
Answered by AI
Are participants aged sixty and over eligible for this investigation?
"In agreement with the requirements for this research, no patient may be under 18 or over 60 years of age."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
Austin Ortho Biologics / Seton Medical Center Austin
What portion of applicants met pre-screening criteria?
Met criteria
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