The current study compares the efficacy and safety of the Agili-C implant to Surgical Standard of Care treatment in patients suffering from joint surface lesions of the knee. The patient population is heterogeneous, involving different kinds of joint surface lesions: focal cartilage lesions, osteochondral defects and mild to moderate osteoarthritis, including multiple defects.
Who can participate
Age range21 Years ā 75 Years
SexALL
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Inclusion criteria
ā. 21 -75 years
ā. Up to 3 treatable joint surface lesion(s), ICRS Grade III or above, on the femoral condyles and/or trochlea
ā. Symptomatic total treatable area 1-7 cm2. Asymptomatic lesions will not be included in the calculation
ā. Must be physically and mentally willing and able to comply with the post-operative rehabilitation protocol and scheduled clinical and radiographic visits
ā. Signed and dated the IRB/Ethics Committee approved Informed Consent Form and HIPPA (if applicable)
ā. Non-responsive to physical therapy for at least 3-4 weeks
Exclusion criteria
ā. KOOS Pain Subscale score at baseline is less than 20 or more than 65 (scale: maximum pain =0, pain free =100)
ā. Bony defect depth deeper than 8mm, according to baseline MRI/X-ray/arthroscopy
ā. Articular cartilage lesions in the tibia or the patella, ICRS grades IVa or above
ā. Osteoarthritis of the index knee graded 4 according to the Kellgren-Lawrence Grading
ā. Significant instability of the index knee according to IKDC Knee Examination Form 2000, Grade C (abnormal) or D (severely abnormal)
ā. Malalignment more than 8 degrees varus OR 8 degrees valgus according to standing X-ray
What they're measuring
1
Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Baseline to 60 Months