What side effects are associated with this type of intervention?

Common treatments for cartilage injury, such as scaffold-based approaches like Chondro-Gide® ACC, microfracture techniques, concentrated bone marrow aspirate (BMAC), and platelet-rich plasma (PRP) injections, generally have a favorable safety profile. However, they can be associated with some side effects. Scaffold-based treatments and microfracture can lead to postoperative pain, swelling, and a risk of infection. BMAC and PRP injections are considered safe but may cause minor and transient side effects such as pain, bleeding, tenderness, swelling, and bruising at the injection site. There is also a general risk of local infection with any intraarticular injection.

What prior FDA approvals exist?

The FDA has approved several treatments for cartilage injuries, including autologous chondrocyte implantation (ACI) and matrix-induced autologous chondrocyte implantation (MACI). These treatments involve harvesting a patient's own cartilage cells, culturing them, and re-implanting them into the cartilage defect using a scaffold or matrix to support cell growth and integration. Other approved treatments include microfracture surgery, which stimulates the growth of new cartilage by creating small fractures in the underlying bone. While specific information on Chondro-Gide® ACC is limited, these approved therapies share a similar goal of promoting cartilage repair and regeneration.

What other types of research exist?

Promising alternatives to Chondro-Gide® ACC for cartilage repair include: 1) Autologous Chondrocyte Implantation (ACI) using matrix-induced techniques, 2) Mesenchymal Stem Cell (MSC) therapies, 3) Bioengineered scaffolds such as those incorporating hyaluronic acid or collagen, and 4) Gene therapy approaches targeting cartilage regeneration. These alternatives have shown potential in recent clinical trials and studies for effective cartilage repair.

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Chondro-Gide® for Knee Cartilage Injury (SECURE Trial)

Q: What is the mechanism of action of this treatment?

Common treatments for cartilage injury include microfracture, scaffold-based therapies like Chondro-Gide® ACC, and biologic therapies such as platelet-rich plasma (PRP) and mesenchymal stem cells (MSCs). Microfracture involves creating small holes in the subchondral bone to stimulate the release of bone marrow cells, promoting the formation of new cartilage. Scaffold-based therapies, like Chondro-Gide® ACC, provide a structure that supports the growth and organization of new cartilage cells, enhancing the repair process. PRP involves injecting a concentration of a patient's own platelets to release growth factors that aid in tissue healing and reduce inflammation. MSCs are multipotent cells that can differentiate into cartilage cells and secrete bioactive molecules to support tissue repair. These treatments are crucial for cartilage injury patients as they aim to restore the damaged cartilage, improve joint function, and reduce pain, ultimately enhancing the patient's quality of life.

N/A

Recruiting

Led By Kevin Plancher, MD

Research Sponsored by Geistlich Pharma AG

Eligibility Criteria Checklist

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

Must have

One symptomatic knee with cartilage defect on the medial femoral condyle, lateral femoral condyle, or trochlea, identified MRI or arthroscopy

Between 18 and 55 years of age

Must not have

Pregnancy or lack of adequate contraceptives if a female of child-bearing potential

Active infection of the index knee

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a special surgery combined with a protective membrane to treat large knee cartilage damage. It aims to help patients who might not benefit as much from the surgery alone. The treatment encourages new cartilage growth and protects it with the membrane.

Who is the study for?

This trial is for individuals aged 18-55 with knee pain due to cartilage defects, who can follow the study's procedures and rehab protocol. They must not be overweight (BMI <30), have no severe knee issues on the other side, no allergies to porcine collagen, or recent treatments that could affect results like steroids or joint injections.

What is being tested?

The study tests if treating large knee cartilage lesions with microfracture surgery plus Chondro-Gide® ACC is as effective as treating smaller lesions with just microfracture. It's a multi-center, non-randomized trial where patients and assessors don't know which treatment was given.

What are the potential side effects?

Possible side effects may include discomfort at the surgery site, swelling in the knee, allergic reactions to materials used (if there's an unknown allergy), and typical surgical risks such as infection.

Eligibility Criteria

Inclusion Criteria

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

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I have a knee injury identified by MRI or arthroscopy.

Select...

I am between 18 and 55 years old.

Exclusion Criteria

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

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I am not pregnant and use effective birth control.

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My knee is currently infected.

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I have long-term arthritis caused by inflammation or infection.

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I do not have any health conditions that would affect the study's outcome measurements.

Select...

I have not used steroids directly in my joints in the last 3 months.

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I have an abnormal kneecap shape.

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I have been diagnosed with osteoporosis through a bone density scan.

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My arthritis is severe, as shown by my X-rays.

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My other knee hurts.

Select...

I am currently on treatment with radiation, chemotherapy, or steroids stronger than 5 mg of prednisolone.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Patients achieving composite clinical success (CCS) at 24 months follow-up, with CCS

Secondary study objectives

Employment status

EuroQol-5 Dimension (EQ-5D)

Knee Injury and Osteoarthritis Outcome Score

+3 more

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: Investigational GroupExperimental Treatment1 Intervention

Patients with large chondral lesions of the knee

Group II: Control ArmActive Control1 Intervention

Patients with small chondral lesions of the knee

0 / 12Eligibility 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 cartilage injury include microfracture, scaffold-based therapies like Chondro-Gide® ACC, and biologic therapies such as platelet-rich plasma (PRP) and mesenchymal stem cells (MSCs). Microfracture involves creating small holes in the subchondral bone to stimulate the release of bone marrow cells, promoting the formation of new cartilage. Scaffold-based therapies, like Chondro-Gide® ACC, provide a structure that supports the growth and organization of new cartilage cells, enhancing the repair process. PRP involves injecting a concentration of a patient's own platelets to release growth factors that aid in tissue healing and reduce inflammation. MSCs are multipotent cells that can differentiate into cartilage cells and secrete bioactive molecules to support tissue repair. These treatments are crucial for cartilage injury patients as they aim to restore the damaged cartilage, improve joint function, and reduce pain, ultimately enhancing the patient's quality of life.