Clinical trial NCT02423629: Agili-C™ Implant Performance Evaluation in the Repair of Cartilage and Osteochondral Defects
Official title: Agili-C™ Implant Performance Evaluation in the Repair of Cartilage and Osteochondral Defects (OCD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cartilage or Osteochondral Defects in the Knee
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2015-04-22
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: • The KOOS Pain Subscale relative to baseline
timeFrame: 24 Months
Secondary outcomes:
measure: • Improvement in other KOOS subscales relative to baseline
timeFrame: 24 Months
measure: • Improvement in IKDC Subjective Knee Score relative to baseline
timeFrame: 24 Months
measure: • Improvement in SF-36 Survey
timeFrame: 24 Months
measure: • Improvement in Tegner Score
timeFrame: 24 Months
measure: • Improvement in Lysholm Knee Scoring Scale
timeFrame: 24 Months
measure: • Joint Space maintenance rate according to X-ray
timeFrame: 24 Months
measure: • Defect Fill according to MRI
timeFrame: 24 Months
measure: Improvement of Overall KOOS (average of all KOOS Subscales) relative to baseline
timeFrame: 24 mMonths
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Antwerpen
country: Belgium
facility: AZ Monica
city: Petah Tikva
country: Israel
facility: Hasharon medical center
city: Bologna
country: Italy
facility: Rizzoli Orthopaedic Institute
city: Kraków
country: Poland
facility: Specialist Hospital. Louis Rydygier
city: Timişoara
country: Romania
facility: Timişoara County Hospital
city: Belgrade
country: Serbia
facility: Institut za Ortopedsko-hirurške Bolesti "banjica"
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
Study officials:
affiliation: Rizzoli Institute, Bologna , Italy
name: Elizaveta Kon, MD
role: PRINCIPAL_INVESTIGATOR
References: