What side effects are associated with this type of intervention?

Common treatments for osteochondral defects, such as microfracture, autologous chondrocyte implantation (ACI), and osteochondral autograft transplantation (OAT), have several known side effects. Microfracture can lead to fibrocartilage formation, which is less durable than normal cartilage, and may result in joint stiffness and pain. ACI can cause complications such as graft hypertrophy, delamination, and potential for uneven cartilage repair. OAT may result in donor site morbidity, where the site from which the graft is taken experiences pain or dysfunction. Additionally, all these procedures carry general surgical risks like infection, bleeding, and deep vein thrombosis.

What prior FDA approvals exist?

The FDA has approved several treatments for osteochondral defects, focusing on cartilage repair and regeneration. These include autologous chondrocyte implantation (ACI), where a patient's own cartilage cells are harvested, cultured, and re-implanted into the defect site. Additionally, matrix-induced autologous chondrocyte implantation (MACI) uses a similar approach but incorporates a scaffold to support cell growth. Other treatments involve the use of osteochondral allografts, where donor cartilage and bone are transplanted to repair the defect. These therapies aim to restore joint function and reduce pain by regenerating healthy cartilage tissue.

What other types of research exist?

Promising novel alternatives to the Agili-C implant for osteochondral defects include: 1) Injectable soft tissue fillers like hyaluronic acid and calcium hydroxylapatite, which have shown efficacy in tissue augmentation and repair. 2) Stem cell therapies, particularly those using mesenchymal stem cells (MSCs), which have demonstrated potential in promoting cartilage regeneration and reducing inflammation. 3) Protein replacement therapies, such as recombinant collagen type VII, which have shown promise in preclinical studies for repairing cartilage defects. These alternatives are in various stages of clinical trials and may offer effective treatment options in 2024.

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Implant

Agili-C™ Implant for Knee Joint Problems

N/A

Waitlist Available

Led By Elizaveta Kon, MD

Research Sponsored by Cartiheal (2009) Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age between 21-75 years

Symptomatic total treatable area 1-7 cm2. Asymptomatic lesions will not be included in the calculation

Must not have

Known insulin dependent diabetes mellitus

Any known history of inflammatory arthropathy or crystal-deposition arthropathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up preoperative until 2 years postoperatively

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the Agili-C implant, which helps repair damaged knee joints. It targets patients with various types of knee damage, including cartilage issues and mild to moderate osteoarthritis. The implant works by supporting and promoting the growth of new, healthy tissue in the knee. Agili-C™ is designed to support the knee's structure and function, helping to repair cartilage and bone.

Who is the study for?

This trial is for adults aged 21-75 with knee joint surface lesions or mild to moderate osteoarthritis, who haven't improved with physical therapy. Participants must be able to follow post-op rehab and attend check-ups. Exclusions include severe systemic diseases, certain medications, extreme pain levels, deep bony defects, other knee cartilage issues, obesity (BMI > 35), recent chemo or surgery in the affected knee.

What is being tested?

The study compares the Agili-C implant's effectiveness and safety against standard surgical care for various knee joint surface lesions. It includes patients with focal cartilage damage or early-stage osteoarthritis and assesses how well they recover after treatment.

What are the potential side effects?

While specific side effects are not listed here, potential risks may include typical surgical complications such as infection risk at the implant site, inflammation around the area of surgery, allergic reactions to implant materials like calcium carbonate or hyaluronate.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 21 and 75 years old.

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I have painful skin areas totaling 1-7 cm2.

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I have up to 3 severe knee joint surface lesions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have diabetes and need insulin.

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I have a history of joint inflammation or crystal buildup in my joints.

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I had a meniscal transplant within the last 6 months.

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I have a tumor in my knee.

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I have had an infection in my knee joint or bone.

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My knee's cushioning is mostly gone, but a small part remains.

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My bone defect is deeper than 8mm as shown by an MRI, X-ray, or arthroscopy.

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My knee cartilage damage is severe (grade IVa or higher).

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My knee is significantly unstable, rated as abnormal or severely abnormal.

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I do not have any known bone or cartilage disorders like osteoporosis.

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I have not had knee surgery for cartilage issues in the last 6 months.

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I do not have a history of significant diseases like HIV or hepatitis.

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My lesion is not fully enclosed by a thick bone wall.

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My knee arthritis is severe, as per the Kellgren-Lawrence scale.

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I have not had chemotherapy in the last 12 months.

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My knee bends inward or outward more than 8 degrees.

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My knee pain score is either below 20 or above 65.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ preoperative until 2 years postoperatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~preoperative until 2 years postoperatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and preoperative until 2 years postoperatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

KOOS Score

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Agili-CExperimental Treatment1 Intervention

Group II: Surgical Standard of Care (SSOC)Active Control1 Intervention

0 / 20Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for osteochondral defects include microfracture surgery, autologous chondrocyte implantation (ACI), and osteochondral autograft transplantation (OAT). Microfracture surgery involves creating small fractures in the underlying bone to stimulate the formation of new cartilage. ACI involves harvesting a patient's own cartilage cells, culturing them, and re-implanting them into the defect. OAT involves transplanting healthy cartilage and bone from a non-weight-bearing area to the defect site. These treatments aim to restore the cartilage surface, reduce pain, and improve joint function. The Agili-C implant, a regenerative cartilage implant, works similarly by promoting the repair of joint surface lesions, which is crucial for patients as it can potentially provide a more durable and effective solution for cartilage regeneration and joint function restoration.