Agili-C™ Implant Performance Evaluation in the Repair of Cartilage and Osteochondral Defects

NCT ID: NCT02423629

Last Updated: 2025-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 143 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2019-11-19

Brief Summary

Evaluate the performance of the Agili-C™ in the repair of Cartilage and Osteochondral defects.

Detailed Description

Agili-C™ implant is a CE marked, bi-phasic, porous resorbable tissue regeneration scaffold for the treatment of articular cartilage and/or osteochondral defects.

The Agili-C™ implant will be implanted using the Agili-Kit™ surgical toolset which is designed for the precise preparation of sites in cartilage and osteochondral defects, for implanting the Agili-C™ implant

Conditions

Cartilage or Osteochondral Defects in the Knee

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Agili C™

Candidates will be screened for possible inclusion in the trial. Candidates that are approved by the adjudication committee will be considered for study enrollment and then operated. Note: in case intra-operatively a medical condition is observed which is not aligned with the inclusion/exclusion criteria, the Subject will not be implanted with the Agili-C™ device and will not be considered enrolled in the study.

Group Type: OTHER

Agili-C™ implantation procedure

Intervention Type: DEVICE

Candidates for Agili-C™ implantation will be screened for possible inclusion in the trial. Candidates that are approved by the adjudication committee will be considered for study enrollment and then operated. Note: in case intra-operatively a medical condition is observed which is not aligned with the inclusion/exclusion criteria, the Subject will not be implanted with the Agili-C™ device and will not be considered enrolled in the study.

Interventions

Agili-C™ implantation procedure

Candidates for Agili-C™ implantation will be screened for possible inclusion in the trial. Candidates that are approved by the adjudication committee will be considered for study enrollment and then operated. Note: in case intra-operatively a medical condition is observed which is not aligned with the inclusion/exclusion criteria, the Subject will not be implanted with the Agili-C™ device and will not be considered enrolled in the study.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. 18 years or older

2. Up to 3 treatable cartilage lesions, ICRS IIIa - IVb on the femoral condyles or the trochlea,

3. Symptomatic total treatable area 1-7 cm2. Asymptomatic lesions will not be included in the calculation

4. KOOS Pain score at baseline is not less than 30 and not more than 65

5. Must be physically and mentally willing and able to comply with post- operative rehabilitation protocol and scheduled clinical and radiographic visits.

6. Informed consent signing

Exclusion Criteria

1. Bony defect depth deeper than 8mm, according to imaging Articular cartilage lesions in the tibia or the patella, ICRS grades IVa and IVb

2. Any previous ligamentous repair or malalignment correction in the index knee within the last 3 months

3. Significant instability of the index knee according to IKDC Knee Examination Form 2000, Grade C (abnormal) or D (severely abnormal)

4. Lack of functional remaining meniscus

5. Meniscal transplantation in the past 6 months

6. Malalignment more than 5 degrees varus OR 5 degrees valgus according to standing X-ray

7. Any known tumor of the index knee

8. Any know history of infection of the index knee

9. Any known history of inflammatory arthropathy or crystal-deposition arthropathy

10. Any known systemic cartilage and/or bone disorder such as but not limited to chondrodysplasia or osteogenesis imperfecta

11. Body mass index >35

12. Osteoarthritis of the index knee graded as 4 according to the Kellgren- Lawrence scale

13. Chemotherapy treatment in the past 12 months

14. Any previous surgical cartilage treatment in the index knee within the last 6 months

15. History of allergic reaction or intolerance of materials containing calcium carbonate or hyaluronate

16. Patient who is pregnant or intends to become pregnant during the study

17. History of any significant systemic disease, such as but not limited to, HIV infection, hepatitis infection or HTLV infection; known coagulopathies, that might compromise the subject's welfare

18. Known substance abuse or alcohol abuse

19. Participation in other clinical trials within 30 days prior to the study or concurrent with the study

20. Known insulin dependent diabetes mellitus

21. Unable to undergo MRI or X-ray

• Minimum Eligible Age: 18 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

Rizzoli Institute, Bologna , Italy

Locations

Medical University of Vienna

Vienna, , Austria

AZ Monica

Antwerp, , Belgium

Hasharon medical center

Petah Tikva, , Israel

Rizzoli Orthopaedic Institute

Bologna, , Italy

Specialist Hospital. Louis Rydygier

Krakow, , Poland

Timişoara County Hospital

Timișoara, , Romania

Institut za Ortopedsko-hirurške Bolesti "banjica"

Belgrade, , Serbia

University Medical Centre Ljubljana

Ljubljana, , Slovenia

Countries

Austria; Belgium; Israel; Italy; Poland; Romania; Serbia; Slovenia

Other Identifiers

CLN0019

Identifier Type: -

Identifier Source: org_study_id