Evaluation of the Agili-C Biphasic Implant in the Knee Joint
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01471236 |
Recruitment Status :
Completed
First Posted : November 15, 2011
Last Update Posted : February 11, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cartilage Diseases Osteochondritis Dissecans | Device: Agili-C Bi-phasic Implant Procedure: mini-arthrotomy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 65 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Evaluation of the Agili-C Bi-phasic Implant Performances in the Repair of Cartilage and Osteochondral Defects |
Study Start Date : | June 2011 |
Actual Primary Completion Date : | November 19, 2018 |
Actual Study Completion Date : | November 19, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Agili-c bi-phasic implant
mini-arthrotomy
|
Device: Agili-C Bi-phasic Implant
The implantation site should be created in perpendicular manner to the articular cartilage. The surrounding tissue will be cleaned and scraped to prepare a clean site. The implant will be placed in the correct orientation (drilled channels pointing towards the joint side and chamfer towards the bone). The implant will be inserted gently in a pressed fit manner. Other Name: Agili-C implant Procedure: mini-arthrotomy The procedure will be conducted according to hospital practice. The implants will be positioned via open incision, depending on lesion location, and Investigator's final decision. Related treatments during the procedure should be recorded. Device positioning details medications and adverse events during the procedure will be recorded. MOCART (off-site), X-ray evaluation (off-site), ICRS Cartilage injury mapping system, Articular cartilage injury Classification and the Osteochondritis Dissecans classification will be recorded. |
- improvement in KOOS pain subscales [ Time Frame: 24 months ]The primary efficacy endpoint for this trial will be the change from baseline up to 24 months visit in pain score as measured by the KOOS pain subscale
- KOOS total score [ Time Frame: 24 months ]
- Change from baseline to 3, 6, 9, 12, 18 and 24 months visits as measured by the KOOS total score and subscales.
- Change from baseline to 18 and 24 months visit in IKDC current health assessment.
- Change from baseline to 3, 6, 12, 18 and 24 months visit in Lysholm with Tegner knee score.
- Change from baseline to 3, 6, 12 , 18 and 24 months visit in IKDC knee examination form 2000
- Change from baseline to 3, 6, 12 , 18 and 24 months visit in IKDC subjective knee evaluation
- Change in MOCART scoring as measured at 3, 6, 12 , 18 and 24 months visit
- number of SAE [ Time Frame: 24 months ]Complications and adverse events, device-related or not, will be evaluated over the course of the clinical trial, including subsequent surgical interventions

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
- 18 to 55 years
-
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.
- Primary or secondary articular cartilage repair.
- Knee is stable or can be stabilized as a concomitant procedure.
- Must be physically and mentally willing and able to comply with post-operative rehabilitation and routinely schedule clinical and radiographic visits.
- Signed informed consent.
- Any misalignments should be fully corrected at the end of the operative procedure.
Exclusion Criteria
- Uncorrected axial misalignments >5° that cannot be corrected.
- Patellar cartilage defects or pathology.
- Meniscal resection of more than 50%, either in a previous procedure or concomitant with articular cartilage repair.
- Any tumor of the ipsilateral knee, any concurrent malignant tumor or any metastatic tumor in the past or in the present.
- Active acute or chronic infection of the treated knee.
- Inflammatory arthropathy or crystal-deposition arthropathy.
- 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.
- Bony defect depth over 3 millimeters.
- Body mass index >35.
- Asymptomatic articular cartilage defects.
- Bipolar articular cartilage defects.
- Osteoarthritis of the operated knee.
-
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
- Patients who are sensitive to materials containing calcium carbonate or hyaluronate
- Pregnant women, women who plan to become pregnant and breastfeeding women.
- 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.
- Substance abuse or alcohol abuse.
- Participation in another clinical trials in parallel to this study.
- Type I diabetes.
- Unable to undergo MRI or X-ray.
- Any reasons making the patient a poor candidate in the opinion of the investigator.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01471236
Croatia | |
Clinical Hospital ''Sveti Duh'' | |
Zagreb, Croatia | |
Czechia | |
Fakultní nemocnice Brno | |
Brno, Czechia | |
Hungary | |
Uzsoki Street Hospital | |
Budapest, Hungary | |
Italy | |
Rizzoli Orthopaedic Institute | |
Bologna, Italy | |
Romania | |
County Hospital of Timisoara, | |
Timisoara, Romania, 300203 | |
Serbia | |
Institut za Ortopedsko-hirurške | |
Belgrade, Serbia | |
Clinical center of Vojvodina | |
Novi Sad, Serbia |
Principal Investigator: | Elizaveta Kon, MD |
Responsible Party: | Cartiheal (2009) Ltd |
ClinicalTrials.gov Identifier: | NCT01471236 |
Other Study ID Numbers: |
CLN0002 |
First Posted: | November 15, 2011 Key Record Dates |
Last Update Posted: | February 11, 2020 |
Last Verified: | February 2020 |
cartilage bone |
Osteochondritis Osteochondritis Dissecans Cartilage Diseases |
Bone Diseases Musculoskeletal Diseases Connective Tissue Diseases |