Clinical trial NCT01471236: Evaluation of the Agili-C Biphasic Implant in the Knee Joint
Official title: Evaluation of the Agili-C Bi-phasic Implant Performances in the Repair of Cartilage and Osteochondral Defects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cartilage Diseases
Osteochondritis Dissecans
Keywords: cartilage
bone
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2011-11-15
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the performance of the Agili-C implants. The study hypothesis is that Agili-C implants are effective in the treatment of focal cartilage and cartilage-bone joint surface defects.

Detailed description: Agili-C implant is a bi-phasic, porous resorbable tissue regeneration scaffold for the treatment of focal articular cartilage and for osteochondral defects. Up to 50 patients are to be included in the study. Patients suffering from isolated, single and focal cartilage or osteochondral defect at the knee joint are considered for study inclusion.

Eligibility criteria: Inclusion Criteria

1. 18 to 55 years
2. Symptomatic, single, focal, full or near full-thickness (ICRS cartilage defect description grades 3 and 4) chondral or osteochondral isolated lesion of the femoral condyle, trochlea or the tibial plateau

   * Defect area is less than 2 cm² after debridement. The defect is completely surrounded on all sides by healthy cartilage.
   * Osteochondral defect ICRS Cartilage defect description type 1, 2, 3, 4A. Maximal defect depth should be up to 3 millimeters.
3. Primary or secondary articular cartilage repair.
4. Knee is stable or can be stabilized as a concomitant procedure.
5. Must be physically and mentally willing and able to comply with post-operative rehabilitation and routinely schedule clinical and radiographic visits.
6. Signed informed consent.
7. Any misalignments should be fully corrected at the end of the operative procedure.

Exclusion Criteria

1. Uncorrected axial misalignments \>5° that cannot be corrected.
2. Patellar cartilage defects or pathology.
3. Meniscal resection of more than 50%, either in a previous procedure or concomitant with articular cartilage repair.
4. Any tumor of the ipsilateral knee, any concurrent malignant tumor or any metastatic tumor in the past or in the present.
5. Active acute or chronic infection of the treated knee.
6. Inflammatory arthropathy or crystal-deposition arthropathy.
7. Systemic cartilage and/or bone disorder; This implants integration is dependent on surrounding live bleeding bone; therefore it must not be implanted within sequestrated or necrotic bone.
8. Bony defect depth over 3 millimeters.
9. Body mass index \>35.
10. Asymptomatic articular cartilage defects.
11. Bipolar articular cartilage defects.
12. Osteoarthritis of the operated knee.
13. Oral medications such as systemic corticosteroid therapy taken less than one year prior to surgery or chemotherapy.

    * Previous operative treatment of Arthroscopic marrow stimulation technique or cell therapy operated within the last 6 months
    * Any previous operation of cartilage treatment within the last 6 months
14. Patients who are sensitive to materials containing calcium carbonate or hyaluronate
15. Pregnant women, women who plan to become pregnant and breastfeeding women.
16. Evidence of any significant systemic disease (such as but not limited to HIV infection, hepatitis infection or HTLV infection), known coagulopathies, severe vascular or neurological disease or acute injury that might compromise the patient's welfare.
17. Substance abuse or alcohol abuse.
18. Participation in another clinical trials in parallel to this study.
19. Type I diabetes.
20. Unable to undergo MRI or X-ray.
21. Any reasons making the patient a poor candidate in the opinion of the investigator.

Primary outcomes:
measure: improvement in KOOS pain subscales
timeFrame: 24 months
Secondary outcomes:
measure: KOOS total score
timeFrame: 24 months
Other outcomes:
measure: number of SAE
timeFrame: 24 months
Locations:
city: Zagreb
country: Croatia
facility: Clinical Hospital ''Sveti Duh''
city: Brno
country: Czechia
facility: Fakultní nemocnice Brno
city: Budapest
country: Hungary
facility: Uzsoki Street Hospital
city: Bologna
country: Italy
facility: Rizzoli Orthopaedic Institute
city: Katowice
country: Poland
facility: Avimed Hospital
city: Timisoara
country: Romania
facility: County Hospital of Timisoara,
city: Belgrade
country: Serbia
facility: Institut Za Ortopediju "Banjica"
city: Novi Sad
country: Serbia
facility: Clinical center of Vojvodina
city: Ljubljana
country: Slovenia
facility: University Medical Centre, Ljubljana
Study officials:
name: Elizaveta Kon, MD
role: PRINCIPAL_INVESTIGATOR
References: