Agili-C™ Implant Performance Evaluation

NCT ID: NCT03299959

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 251 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-25
• Study Completion Date: 2024-11-14

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Agili-C

Group Type: EXPERIMENTAL

Agili-C implant

Intervention Type: DEVICE

Agili-C implant

Surgical Standard of Care (SSOC)

Group Type: ACTIVE_COMPARATOR

SSOC

Intervention Type: PROCEDURE

microfracture and/or debridement

Interventions

Agili-C implant

Agili-C implant

Intervention Type: DEVICE

SSOC

microfracture and/or debridement

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Smith & Nephew, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizaveta Kon, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Clinico Humanitas, Via A. Manzoni 56, Rozzano, Milano, Italy

Locations

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

Clinical Center of Vojvodina

Novi Sad, , Serbia

Countries

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

References

Kon E, De Caro F, Dasa V, M Scopp J, Di Matteo B, Flanigan D, Shabshin N, Strickland S, Altschuler N. Female patients report comparable results to males after the implantation of an aragonite-based scaffold for the treatment of knee chondral and osteochondral defects: a gender-based analysis of a RCT at 4 years' follow-up. J Orthop Traumatol. 2025 Mar 13;26(1):17. doi: 10.1186/s10195-025-00829-y.

Reference Type: DERIVED

PMID: 40080289 (View on PubMed)

Altschuler N, Zaslav KR, Di Matteo B, Sherman SL, Gomoll AH, Hacker SA, Verdonk P, Dulic O, Patrascu JM, Levy AS, Robinson D, Kon E. Aragonite-Based Scaffold Versus Microfracture and Debridement for the Treatment of Knee Chondral and Osteochondral Lesions: Results of a Multicenter Randomized Controlled Trial. Am J Sports Med. 2023 Mar;51(4):957-967. doi: 10.1177/03635465231151252. Epub 2023 Feb 13.

Reference Type: DERIVED

PMID: 36779614 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CLN0021

Identifier Type: -

Identifier Source: org_study_id