HyaloFAST Trial for Repair of Articular Cartilage in the Knee

• Register: ClinicalTrials.gov
• Last refreshed on: 3 July 2023
• Main ID: NCT02659215
• Date of registration: 14/01/2016
• Prospective Registration: No
• Primary sponsor: Anika Therapeutics, Inc.
• Public title: HyaloFAST Trial for Repair of Articular Cartilage in the Knee FastTRACK
• Scientific 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
• Date of first enrolment: December 2015
• Target sample size: 200
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02659215
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Austria, Estonia, Hungary, Indonesia, Italy, Lithuania, Mexico, Philippines, United States

Contacts

• Name: Alberto Gobbi, MD
• Affiliation: OASI Bioresearch Foundation

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Defect of Articular Cartilage

Intervention(s)

Procedure: Microfracture

Device: Hyalofast

Primary Outcome(s)

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]

Superiority of Hyalofast with Bone Marrow Aspirate Concentrate (BMAC) vs. Microfracture for % Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score [Time Frame: 2 years post-surgery]

Secondary Outcome(s)

The incidence, timing, severity, and relationship to treatment of all Adverse Events (AE), will be collected for all participants. [Time Frame: 3 years post-surgery]

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

Superiority of Hyalofast® with autologous BMAC vs. Microfracture for change in MRI MOCART Score from baseline to two years post-surgery [Time Frame: 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 [Time Frame: 2 years post-surgery]

Secondary ID(s)

Hyalofast 15-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors