Efficacy and Safety Study of co.Don Chondrosphere to Treat Cartilage Defects

see above

Inclusion criteria

• Male or female patients, age: between 18 and 50 years
• Defect: isolated ICRS grade III or IV single defect chondral lesions on femoral condyles
• Defect size: 1 to < 4 cm2 after debridement to healthy cartilage up to 6 mm in depth.Assessment with MRI at screening and per estimation during arthroscopy prior to randomization
• Nearly intact chondral structure surrounding the defect as well as an intact corresponding joint area
• Informed consent signed and dated by patient
• Patient understands the strict rehabilitation protocol and follow-up programme and is willing to follow it
• In case of pain, patient agrees to use only paracetamol mono- (max 4 g/day) or combination preparation and oral and/or topic NSAIDs during the trial and to discontinue the use of oral and/or topic NSAIDs and/or paracetamol combination preparation 1 week before each visit whereas the use of paracetamol monopreparation (max 4 g/day) is allowed. However, in the morning of the visit day, no pain medication is allowed. Other pain medications are allowed during surgical procedure and may be taken for a period not exceeding 4 weeks after surgery.

Exclusion criteria

• Defects on both knees at the same time
• Radiological signs of osteoarthritis
• Osteochondritis dissecans (OCD)
• Any signs of knee instability
• Valgus or varus malalignment (more than 5° over the mechanical axis)
• Clinically relevant second cartilage lesion on the same knee
• More than 50 % resection of a meniscus in the affected knee or incomplete meniscal rim
• Rheumatoid arthritis, parainfectious or infectious arthritis, and condition after these diseases
• Pregnancy and planned pregnancy (no MRI possible)
• Obesity (Body Mass Index >30)
• Uncontrolled diabetes mellitus
• Serious illness
• Poor general health as judged by physician
• Participation in concurrent clinical trials or previous trials within 3 months of screening
• Previous treatment with ACT in the affected knee
• Microfracture performed less than 1 year before screening in the affected knee
• Alcohol or drug (medication) abuse
• Meniscal transplant in the affected knee
• Meniscal suture (in the affected knee) three months prior to baseline
• Mosaicplasty (Osteoarticular Transplant System, OATS) in the affected knee
• Having received hyaluronic acid intra-articular injections in the affected knee within the last 3 months before baseline
• Taking specific osteoarthritis drugs such as chondroïtin sulfate, diacerein, nglucosamine,piascledine, capsaicin within 2 weeks before baseline
• Corticosteroid treatment by systemic or intraarticular route within the last month of baseline or intramuscular or oral corticosteroïds within the last 2 weeks before baseline
• Chronic use of anticoagulants
• Any concomitant painful or disabling disease of the spine, hips or lower limbs that would interfere with evaluation of the afflicted knee
• Any clinically significant or symptomatic vascular or neurological disorder of the lower extremities
• Any evidence of the following diseases in the affected knee: septic arthritis, inflammatory joint disease, recurrent episodes of pseudogout, Paget's disease of bone, ochronosis, acromegaly, haemochromatosis, Wilson's disease, primary osteochondromatosis, heritable disorders, collagen gene mutation
• Current diagnosis of osteomyelitis, human immunodeficiency virus (HIV-1,-2) and/or hepatitis C virus (HCV) infection