Agili-C™ Implant Performance Evaluation

Completed · Not applicable

Conditions studied: Cartilage or Osteochondral Defects in the Knee, Up to Moderate Osteoarthritis

In brief

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.

Key facts

Study ID

NCT03299959

Run by

Smith & Nephew, Inc.

People needed

251

Starts

2017-09-25

Expected to finish

2024-11-14

Last updated by the study team

2025-12-05

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 21 -75 years
• Up to 3 treatable joint surface lesion(s), ICRS Grade III or above, on the femoral condyles and/or trochlea
• Symptomatic total treatable area 1-7 cm2. Asymptomatic lesions will not be included in the calculation
• Must be physically and mentally willing and able to comply with the post-operative rehabilitation protocol and scheduled clinical and radiographic visits
• Signed and dated the IRB/Ethics Committee approved Informed Consent Form and HIPPA (if applicable)
• Non-responsive to physical therapy for at least 3-4 weeks

You may not qualify if…

• KOOS Pain Subscale score at baseline is less than 20 or more than 65 (scale: maximum pain =0, pain free =100)
• Bony defect depth deeper than 8mm, according to baseline MRI/X-ray/arthroscopy
• Articular cartilage lesions in the tibia or the patella, ICRS grades IVa or above
• Osteoarthritis of the index knee graded 4 according to the Kellgren-Lawrence Grading
• Significant instability of the index knee according to IKDC Knee Examination Form 2000, Grade C (abnormal) or D (severely abnormal)
• Malalignment more than 8 degrees varus OR 8 degrees valgus according to standing X-ray
• Lack of functional remaining meniscus, at least 5mm rim at the end of the procedure
• Meniscal transplantation in the past 6 months
• Any known tumor of the index knee
• Any known history of intra-articular or osseous infection of the index knee
• Any evidence of active infection anywhere in the body. Urinary Tract Infection (UTI) patients can be included following antibiotic treatment, and provided that two consecutive cultures are negative (taken within at least 2 weeks of each other)
• Any known history of inflammatory arthropathy or crystal-deposition arthropathy
• Any known systemic cartilage and/or bone disorder, such as but not limited to, osteoporosis, chondrodysplasia or osteogenesis imperfecta
• Body Mass Index (BMI) > 35
• Chemotherapy in the past 12 months
• Any previous surgical cartilage treatment (such as: microfracture, ACI, OATS, etc.) in the index knee within the last 6 months
• Any previous ligamentous repair or malalignment correction in the index knee within the last 6 months
• History of allergic reaction or intolerance of materials containing calcium carbonate or hyaluronate
• Patient who is pregnant or intends to become pregnant during the study
• History of any significant systemic disease, such as but not limited to: HIV, hepatitis, HTLV, syphilis, and coagulopathies
• Known substance or alcohol abuse
• Participation in other clinical trials within 60 days prior to the study or concurrent with the study
• Known insulin dependent diabetes mellitus
• Unable to undergo either MRI or X-ray
• Use of anticoagulation medication or antiaggregant medication; however up to 100 mg Acetylsalicylic acid (ASA) daily is allowed

Where it is running

• Horizon Clinical Research — San Diego, California, United States
• LSU Healthcare Network Orthopedic & Sports Medicine — New Orleans, Louisiana, United States
• Peninsula Orthopaedic Associates — Salisbury, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• University of Missouri, Missouri Orthopaedic Institute — Columbia, Missouri, United States
• NYU Langone Orthopedic Hospital — New York, New York, United States
• Hospital for Special Surgery — New York, New York, United States
• Ohio State University, Wexner Medical Center — Columbus, Ohio, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Arlington Orthopedic Associates — Arlington, Texas, United States
• OrthoVirginia — Richmond, Virginia, United States
• AZ Monica — Antwerp, Belgium
• Uzsoki Utcai Kórház — Budapest, Hungary
• Kastélypark Klinika — Tata, Hungary
• Assaf Harofeh Medical Center — Be’er Ya‘aqov, Israel
• "Carmel" Medical Center — Haifa, Israel
• Hadassah Medical Center — Jerusalem, Israel
• Hasharon Hospital, Petach Tikva — Petah Tikva, Israel
• Souraski Medical Center — Tel Aviv, Israel
• Humanitas Gavazzeni — Bergamo, Italy
• Istituto Clinico Humanitas — Rozzano, Italy
• Specialist Hospital. Louis Rydygier in Krakow — Krakow, Poland
• County Hospital Timis Othopedy and Trauma Clinic — Timișoara, Romania
• Atlas General hospital — Belgrade, Serbia
• Clinic for Orthopedic Surgery "Banjica" — Belgrade, Serbia

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.