HyaloFAST Trial for Repair of Articular Cartilage in the Knee (FastTRACK)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02659215|
Recruitment Status : Recruiting
First Posted : January 20, 2016
Last Update Posted : September 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Defect of Articular Cartilage||Device: Hyalofast Procedure: Microfracture||Not Applicable|
- Prospective, randomized, active treatment-controlled, evaluator-blinded (radiologist reviewer and physician evaluator) multicenter study (up to 40 sites in the US and EU).
- All subjects that meet preoperative screening eligibility criteria will be randomized to treatment with Hyalofast® with BMAC or Microfracture.
- Hyalofast® is a sterile, biodegradable non-woven pad (2 x 2 cm or 5 x 5 cm) that is composed of HYAFF-11®, a benzyl ester of hyaluronic acid. Hyalofast® acts as a biodegradable support for the autologous bone marrow aspirate concentrate. Hyalofast® is soft and conformable and can easily be cut to fit the lesion size.
- Autologous bone marrow is harvested from the subject intraoperatively during the Index Procedure. Approximately 60 mL of bone marrow will be aspirated from the subject's iliac crest using the SmartPrep 2 Bone Marrow Processing Pack. The cellular rich portion will be concentrated via the SmartPrep BMAC 2 Centrifuge System at point-of-care to provide 7 mL of bone marrow aspirate concentrate (BMAC). 1 - 2 mLs will be used for post-procedure testing of total nucleated cells, cell viability, and sterility.
- Hyalofast® with BMAC is implanted during either a standard knee arthroscopy or min-arthrotomy depending upon surgeon preferences and intra-operative findings. The lesion to be treated will be debrided to a stable cartilage margin. The defect will be sized and Hyalofast® will be cut to fit the lesion area. If necessary, more than one Hyalofast® pad can be overlapped to cover the lesion. 2 mL of BMAC will be loaded per Hyalofast® scaffold and then implanted to cover the defect. Hyalofast® with BMAC readily adheres to the site of application, but, if necessary, can be secured to the defect margins with an FDA-approved fibrin glue.
- All subjects will be assessed at intervals post-procedure (1 month, 3 months, 6 months, 12 months, 24 months, and 36 months).
- Subjects will be required to follow a strict pre-specified post-surgery rehabilitation protocol specific to the defect location.
- Measures to assess effectiveness will be conducted at follow-ups, with the primary effectiveness endpoint assessment done at the 24 month timepoint.
- Evaluators doing efficacy assessments of the subject and administering subject-reported outcome instruments will be blinded to the treatment.
- Safety will be assessed by the collection of adverse events at all timepoints.
- Magnetic Resonance Imaging (MRI) will be conducted at Screening, 1 month, 12 months, 24 months, and 36 months. Evaluation of the MRIs, including the MOCART score, will be done by blinded radiologist reviewers. The one month MRI will be used as the baseline MRI for evaluation of treatment effectiveness.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official 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|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2021|
Experimental: Hyalofast with BMAC
A hyaluronan-based scaffold (Hyalofast®) is utilized together with autologous bone marrow aspirate concentrate (BMAC) in a one-step arthroscopic/mini-arthrotomic procedure.
Implantation of Hyalofast scaffold with autologous bone marrow aspirate concentrate via arthroscopy/mini-arthrotomy.
Active Comparator: Microfracture
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.
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
- 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 ]Co-primary endpoint
- 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 ]Co-Primary Endpoint
- 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 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 individual KOOS subscales 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02659215
|Contact: Adrian Orremail@example.com|
|Contact: Richard MacLeod||781 457 firstname.lastname@example.org|
|Principal Investigator:||Alberto Gobbi, MD||OASI Bioresearch Foundation|