An interventional study of Agili-C Bi-phasic Implant and mini-arthrotomy in Cartilage Diseases and Osteochondritis Dissecans, sponsored by Smith & Nephew, Inc.. Completed at 9 sites in 8 countries. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-03-06.
Sponsored by Smith & Nephew, Inc. · Not applicable, Interventional, and Treatment
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.
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.
30 studies on the registry are indexed under Osteochondritis Dissecans; 7 are open to participants now.
This study's enrollment of 65 is above the median of 45 across 17 interventional studies indexed under Osteochondritis Dissecans.
Browse Osteochondritis Dissecans studies →Smith & Nephew, Inc. is the lead sponsor of 134 studies on the registry; 11 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.
Compared within Osteochondritis Dissecans, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Cartilage Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Exclusion Criteria
Oral medications such as systemic therapy taken less than one year prior to surgery or chemotherapy.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
mini-arthrotomy
Device: Agili-C Bi-phasic Implant · Procedure: mini-arthrotomy
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.
Also known as: Agili-C implant
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
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
Time frame: 24 months
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
Time frame: 24 months
number of SAE
Complications and adverse events, device-related or not, will be evaluated over the course of the clinical trial, including subsequent surgical interventions
Time frame: 24 months
The record gives a start of Jun 2011, a primary completion of Nov 2018 and a completion of Nov 2018. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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