Cartilage DiseasesNCT01471236
Evaluation of the Agili-C Biphasic Implant in the Knee Joint
A study testing Agili-C Bi-phasic Implant and mini-arthrotomy in people with Cartilage Diseases and Osteochondritis Dissecans, run by Smith & Nephew, Inc. at 9 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Cartilage Diseases, Osteochondritis Dissecans
- What is being tested?
- Agili-C Bi-phasic Implant and mini-arthrotomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 9 sitesin 8 countries
- Study dates
- Jun 2011to 19 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
9 sites in 8 countries.
9 sites in 8 countries
Serbia2 sites
Institut Za Ortopediju "Banjica"
Belgrade
Clinical center of Vojvodina
Novi Sad
About this study
Official title: Evaluation of the Agili-C Bi-phasic Implant Performances in the Repair of Cartilage and Osteochondral Defects
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.
Read the 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.
- Conditions
- Cartilage Diseases, Osteochondritis Dissecans
- Being tested
- Agili-C Bi-phasic Implant, mini-arthrotomy
- Keywords
- cartilage, bone
- Medical subject headings
- Cartilage Diseases, Osteochondritis Dissecans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Agili-C Bi-phasic ImplantDevice
Also called Agili-C 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.
mini-arthrotomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Agili-c bi-phasic implant | Experimental | mini-arthrotomy Receives: Device: Agili-C Bi-phasic Implant; Procedure: mini-arthrotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement in KOOS pain subscales
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
Measured: 24 months
Secondary outcomes (1)
KOOS total score
- 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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2011 (estimated)
- Study startJun 2011
- Primary completion19 Nov 2018
- Study completion19 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cartilage DiseasesStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elizaveta Kon, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01471236
- Sponsor's protocol ID
- CLN0002
- Status last verified
- Feb 2020
- First submitted
- 10 Nov 2011
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Agili-C Bi-phasic Implant Performances in the Repair of Cartilage and Osteochondral Defects
- ClinicalTrials.gov ID
- NCT01471236
- Acronym / sponsor ID
- CLN0002
- Conditions
- Cartilage Diseases, Osteochondritis Dissecans
- Keywords
- cartilage, bone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- 19 Nov 2018 (actual)
- Study completion
- 19 Nov 2018 (actual)
- First posted
- 15 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Agili-c bi-phasic implant | Experimental | Device: Agili-C Bi-phasic Implant, Procedure: mini-arthrotomymini-arthrotomy |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Agili-C Bi-phasic ImplantAlso: Agili-C implantThe 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. | Device | Agili-c bi-phasic implant |
| mini-arthrotomyThe 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. | Procedure or surgery | Agili-c bi-phasic implant |
Primary outcome
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
1 secondary outcome
KOOS total score
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizaveta Kon, MD principal investigator
9 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Agili-C Bi-phasic Implant and mini-arthrotomy in people with Cartilage Diseases and Osteochondritis Dissecans, run by Smith & Nephew, Inc. at 9 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Serbia, Croatia, Czechia, Hungary, Italy and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement in KOOS pain subscales (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.