Clinical trial NCT03299959: Agili-C™ Implant Performance Evaluation
Official title: A Prospective Multicenter Open-label Randomized Controlled Trial of Agili-C™ vs. Surgical Standard of Care (SSOC) for the Treatment of Joint Surface Lesions of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cartilage or Osteochondral Defects in the Knee
Up to Moderate Osteoarthritis
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2017-10-03
Enrollment: 251
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open-label Randomized Controlled Trial
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. KOOS Pain Subscale score at baseline is less than 20 or more than 65 (scale: maximum pain =0, pain free =100)
2. Bony defect depth deeper than 8mm, according to baseline MRI/X-ray/arthroscopy
3. Articular cartilage lesions in the tibia or the patella, ICRS grades IVa or above
4. Osteoarthritis of the index knee graded 4 according to the Kellgren-Lawrence Grading
5. Significant instability of the index knee according to IKDC Knee Examination Form 2000, Grade C (abnormal) or D (severely abnormal)
6. Malalignment more than 8 degrees varus OR 8 degrees valgus according to standing X-ray
7. Lack of functional remaining meniscus, at least 5mm rim at the end of the procedure
8. Meniscal transplantation in the past 6 months
9. Any known tumor of the index knee
10. Any known history of intra-articular or osseous infection of the index knee
11. 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)
12. Any known history of inflammatory arthropathy or crystal-deposition arthropathy
13. Any known systemic cartilage and/or bone disorder, such as but not limited to, osteoporosis, chondrodysplasia or osteogenesis imperfecta
14. Body Mass Index (BMI) \> 35
15. Chemotherapy in the past 12 months
16. Any previous surgical cartilage treatment (such as: microfracture, ACI, OATS, etc.) in the index knee within the last 6 months
17. Any previous ligamentous repair or malalignment correction in the index knee within the last 6 months
18. History of allergic reaction or intolerance of materials containing calcium carbonate or hyaluronate
19. Patient who is pregnant or intends to become pregnant during the study
20. History of any significant systemic disease, such as but not limited to: HIV, hepatitis, HTLV, syphilis, and coagulopathies
21. Known substance or alcohol abuse
22. Participation in other clinical trials within 60 days prior to the study or concurrent with the study
23. Known insulin dependent diabetes mellitus
24. Unable to undergo either MRI or X-ray
25. Use of anticoagulation medication or antiaggregant medication; however up to 100 mg Acetylsalicylic acid (ASA) daily is allowed
26. Previous intra-articular steroid injection within the last 1 month
27. Prisoners
28. Uncontained lesion - Lack of vital bone wall, at least 2mm thick, completely surrounding the lesion - based on MRI/X-ray/arthroscopy
29. Inability to position the implant 2mm recessed relative to the articular surface - based on MRI/X-ray/arthroscopy

Primary outcomes:
measure: KOOS Score
timeFrame: Preoperative until 5 years postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Horizon Clinical Research
state: California
city: New Orleans
country: United States
facility: LSU Healthcare Network Orthopedic & Sports Medicine
state: Louisiana
city: Salisbury
country: United States
facility: Peninsula Orthopaedic Associates
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Columbia
country: United States
facility: University of Missouri, Missouri Orthopaedic Institute
state: Missouri
city: New York
country: United States
facility: NYU Langone Orthopedic Hospital
state: New York
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Columbus
country: United States
facility: Ohio State University, Wexner Medical Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Arlington
country: United States
facility: Arlington Orthopedic Associates
state: Texas
city: Richmond
country: United States
facility: OrthoVirginia
state: Virginia
city: Antwerpen
country: Belgium
facility: AZ Monica
city: Budapest
country: Hungary
facility: Uzsoki Utcai Kórház
city: Tata
country: Hungary
facility: Kastélypark Klinika
city: Be'er Ya'aqov
country: Israel
facility: Assaf Harofeh Medical Center
city: Haifa
country: Israel
facility: "Carmel" Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Petach Tikva
country: Israel
facility: Hasharon Hospital, Petach Tikva
city: Tel Aviv
country: Israel
facility: Souraski Medical Center
city: Bergamo
country: Italy
facility: Humanitas Gavazzeni
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: Kraków
country: Poland
facility: Specialist Hospital. Louis Rydygier in Krakow
city: Timişoara
country: Romania
facility: County Hospital Timis Othopedy and Trauma Clinic
city: Belgrade
country: Serbia
facility: Atlas General hospital
city: Belgrade
country: Serbia
facility: Clinic for Orthopedic Surgery "Banjica"
city: Novi Sad
country: Serbia
facility: Clinical Center of Vojvodina
Study officials:
affiliation: Istituto Clinico Humanitas, Via A. Manzoni 56, Rozzano, Milano, Italy
name: Elizaveta Kon, MD
role: PRINCIPAL_INVESTIGATOR
References: