Agili-C™ Implant Performance Evaluation
- Conditions
- Up to Moderate OsteoarthritisCartilage or Osteochondral Defects in the Knee
- Interventions
- Device: Agili-C implantProcedure: SSOC
- Registration Number
- NCT03299959
- Lead Sponsor
- Smith & Nephew, Inc.
- Brief Summary
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.
- Detailed Description
This is a prospective, multicenter, open-label, randomized, and controlled trial of Agili-C™ vs. SSOC for the repair of joint surface lesions.
Follow-up visits will be performed at 2 weeks and at 3, 6, 12, 18, 24, 36, 48 and 60 months post-procedure to evaluate the patient's knee condition and clinical health.
The following questionnaires: KOOS, IKDC Knee Examination Form 2000, IKDC Subjective Knee Evaluation , SF-12 Health Survey, Tegner Activity Score will be completed at baseline and at 6, 12, 18, 24, 36, 48 and 60 months.
Anterior-Posterior (A/P) and Lateral knee X-rays will be taken at 2 weeks and at 6, 12, 18 24, 36, 48 and 60 months post procedure. MRI according to specific protocol will be performed at 12 and 24 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 251
- 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
- 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
- Previous intra-articular steroid injection within the last 1 month
- Prisoners
- Uncontained lesion - Lack of vital bone wall, at least 2mm thick, completely surrounding the lesion - based on MRI/X-ray/arthroscopy
- Inability to position the implant 2mm recessed relative to the articular surface - based on MRI/X-ray/arthroscopy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Agili-C Agili-C implant - Surgical Standard of Care (SSOC) SSOC -
- Primary Outcome Measures
Name Time Method KOOS Score Preoperative until 5 years postoperatively Knee Injury and Osteoarthritis Outcome Score (KOOS)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (26)
LSU Healthcare Network Orthopedic & Sports Medicine
🇺🇸New Orleans, Louisiana, United States
Peninsula Orthopaedic Associates
🇺🇸Salisbury, Maryland, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Uzsoki Utcai Kórház
🇭🇺Budapest, Hungary
Istituto Clinico Humanitas
🇮🇹Rozzano, Italy
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Ohio State University, Wexner Medical Center
🇺🇸Columbus, Ohio, United States
University of Missouri, Missouri Orthopaedic Institute
🇺🇸Columbia, Missouri, United States
Arlington Orthopedic Associates
🇺🇸Arlington, Texas, United States
Horizon Clinical Research
🇺🇸San Diego, California, United States
NYU Langone Orthopedic Hospital
🇺🇸New York, New York, United States
Hospital for Special Surgery
🇺🇸New York, New York, United States
OrthoVirginia
🇺🇸Richmond, Virginia, United States
AZ Monica
🇧🇪Antwerpen, Belgium
Assaf Harofeh Medical Center
🇮🇱Be'er Ya'aqov, Israel
Hadassah Medical Center
🇮🇱Jerusalem, Israel
Kastélypark Klinika
🇭🇺Tata, Hungary
"Carmel" Medical Center
🇮🇱Haifa, Israel
Souraski Medical Center
🇮🇱Tel Aviv, Israel
Humanitas Gavazzeni
🇮🇹Bergamo, Italy
Hasharon Hospital, Petach Tikva
🇮🇱Petach Tikva, Israel
Specialist Hospital. Louis Rydygier in Krakow
🇵🇱Kraków, Poland
County Hospital Timis Othopedy and Trauma Clinic
🇷🇴Timişoara, Romania
Atlas General hospital
🇷🇸Belgrade, Serbia
Clinic for Orthopedic Surgery "Banjica"
🇷🇸Belgrade, Serbia
Clinical Center of Vojvodina
🇷🇸Novi Sad, Serbia