Agili-C™ Implant Performance Evaluation

Cartilage or Osteochondral Defects in the Knee Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03299959
• Other study ID #: CLN0021
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 25, 2017
• Est. completion date: September 1, 2024

Study information

• Verified date: January 2023
• Source: Cartiheal (2009) Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 and 24 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 and 24 months. Anterior-Posterior (A/P) and Lateral knee X-rays will be taken at 2 weeks and at 6, 12, 18 and 24 months post procedure. MRI according to specific protocol will be performed at 12 and 24 months.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 251
• Est. completion date: September 1, 2024
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cartilage or Osteochondral Defects in the Knee
• Osteoarthritis
• Up to Moderate Osteoarthritis

Intervention

Device:
• Agili-C implant
Agili-C implant

Procedure:
• SSOC
microfracture and/or debridement

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Cartiheal (2009) Ltd

Countries where clinical trial is conducted

United States,  Belgium,  Hungary,  Israel,  Italy,  Poland,  Romania,  Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	KOOS Score	Knee Injury and Osteoarthritis Outcome Score (KOOS)	Preoperative until 2 years postoperatively