A Treatment Study for Damaged Knee Cartilage Requiring Repair-- Hyalofast with BMAC
Official Title: A prospective, randomized, active treatment-controlled, evaluator-blinded (radiologist reviewer and physician evaluator) multicenter study to establish the superiority of a hyaluronan-based scaffold (Hyalofast®) with autologous bone marrow aspirate concentrate (BMAC) in the treatment of articular knee cartilage defect lesions in comparison to control (microfracture treatment)
The purpose of this research study is to evaluate an investigational procedure for treatment of damage to the cartilage in your knee, also called a defect or lesion, which requires repair. If eligible, you will receive one of two possible arthoscophy procedures. You may be assigned to receive the study procedure to implant Hyalofast® scaffold in your knee together with cells from your own bone marrow, called Bone Marrow Aspirate Concentrate, or BMAC. Bone marrow is the substance found inside your bones that among other things helps to make blood cells. The other possible procedure is called Microfracture and is one of the current standard of care options to treat your condition.
-Ages 18 to 60.
-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--6 cm2 on screening images confirmed by the independent radiologist
-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 to use other pain medication rather than NSAIDS for 6 months post-surgery (e.g. acetaminophen, or narcotic analgesics, if prescribed). Post-surgical use of aspirin for clot prevention is acceptable.
-Patient is willing to restrict pain medication after 6 months post-surgery to NSAIDs or acetaminophen/paracetamol only through the end of the trial
-No history of previous microfracture or other cartilage repair procedure on study knee
-Not currently pregnant or expecting to become pregnant in the next 12 months
-No diagnosis of advanced osteoarthritis