Status:
COMPLETED
Agili-C™ Implant Performance Evaluation
Lead Sponsor:
Smith & Nephew, Inc.
Conditions:
Cartilage or Osteochondral Defects in the Knee
Up to Moderate Osteoarthritis
Eligibility:
All Genders
21-75 years
Phase:
NA
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...
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, ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2024
Estimated Enrollment :
251 Patients enrolled
Trial Details
Trial ID
NCT03299959
Start Date
September 25 2017
End Date
November 14 2024
Last Update
December 5 2025
Active Locations (26)
Enter a location and click search to find clinical trials sorted by distance.
1
Horizon Clinical Research
San Diego, California, United States, 91942
2
LSU Healthcare Network Orthopedic & Sports Medicine
New Orleans, Louisiana, United States, 70112
3
Peninsula Orthopaedic Associates
Salisbury, Maryland, United States, 21804
4
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02467