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

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

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

Study Overview

• Status: Completed
• Conditions: Cartilage or Osteochondral Defects in the Knee
• Intervention / Treatment: Device: Agili-C™ implantation procedure

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

• Study Type: Interventional
• Enrollment (Actual): 143
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria
    • Medical University of Vienna
• Belgium
  • Antwerpen, Belgium
    • AZ Monica
• Israel
  • Petah Tikva, Israel
    • Hasharon Medical Center
• Italy
  • Bologna, Italy
    • Rizzoli Orthopaedic Institute
• Poland
  • Kraków, Poland
    • Specialist Hospital. Louis Rydygier
• Romania
  • Timişoara, Romania
    • Timisoara County Hospital
• Serbia
  • Belgrade, Serbia
    • Institut za Ortopedsko-hirurške Bolesti "banjica"
• Slovenia
  • Ljubljana, Slovenia
    • University Medical Centre Ljubljana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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.

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• The KOOS Pain Subscale relative to baseline	The KOOS pain subscale is evaluated at 6m, 12m, 18m & 24m	24 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• Improvement in other KOOS subscales relative to baseline	Other KOOS subscales are evaluated at 6m, 12m, 18m & 24m	24 Months
• Improvement in IKDC Subjective Knee Score relative to baseline	IKDC Subjective Knee Score is evaluated at 6m, 12m, 18m & 24m	24 Months
• Improvement in SF-36 Survey	SF-36 Survey is evaluated at 6m, 12m, 18m & 24m	24 Months
• Improvement in Tegner Score	Tegner Score is evaluated at 6m, 12m, 18m & 24m	24 Months
• Improvement in Lysholm Knee Scoring Scale	Lysholm Knee Scoring Scale is evaluated at 6m, 12m, 18m & 24m	24 Months
• Joint Space maintenance rate according to X-ray	Joint Space maintenance rate is evaluated at 12m & 24m	24 Months
• Defect Fill according to MRI	Defect Fill according to MRI is evaluated at 6m, 12m, 18m & 24m	24 Months
Improvement of Overall KOOS (average of all KOOS Subscales) relative to baseline	The KOOS Overall is evaluated at 6, 12,18 & 24 months	24 mMonths

Collaborators and Investigators

• Sponsor: Cartiheal (2009) Ltd
• Investigators: Principal Investigator: Elizaveta Kon, MD, Rizzoli Institute, Bologna , Italy

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): November 19, 2019
• Study Completion (Actual): November 19, 2019

Study Registration Dates

• First Submitted: December 3, 2014
• First Submitted That Met QC Criteria: April 19, 2015
• First Posted (Estimate): April 22, 2015

Study Record Updates

• Last Update Posted (Actual): August 30, 2021
• Last Update Submitted That Met QC Criteria: August 25, 2021
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Osteochondrosis
• Other Study ID Numbers: CLN0019