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

Cartilage or Osteochondral Defects in the Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02423629
• Other study ID #: CLN0019
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: November 19, 2019

Study information

• Verified date: October 2019
• Source: Cartiheal (2009) Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: November 19, 2019
• Est. primary completion date: November 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cartilage or Osteochondral Defects in the Knee

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Cartiheal (2009) Ltd

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• The KOOS Pain Subscale relative to baseline	The KOOS pain subscale is evaluated at 6m, 12m, 18m & 24m	24 Months
Secondary	• Improvement in other KOOS subscales relative to baseline	Other KOOS subscales are evaluated at 6m, 12m, 18m & 24m	24 Months
Secondary	• Improvement in IKDC Subjective Knee Score relative to baseline	IKDC Subjective Knee Score is evaluated at 6m, 12m, 18m & 24m	24 Months
Secondary	• Improvement in SF-36 Survey	SF-36 Survey is evaluated at 6m, 12m, 18m & 24m	24 Months
Secondary	• Improvement in Tegner Score	Tegner Score is evaluated at 6m, 12m, 18m & 24m	24 Months
Secondary	• Improvement in Lysholm Knee Scoring Scale	Lysholm Knee Scoring Scale is evaluated at 6m, 12m, 18m & 24m	24 Months
Secondary	• Joint Space maintenance rate according to X-ray	Joint Space maintenance rate is evaluated at 12m & 24m	24 Months
Secondary	• Defect Fill according to MRI	Defect Fill according to MRI is evaluated at 6m, 12m, 18m & 24m	24 Months
Secondary	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