What side effects are associated with this type of intervention?

Minimally invasive treatments for vertebral compression fractures, such as vertebroplasty and kyphoplasty, are generally well-tolerated but can have side effects. Common side effects include pain at the injection site, infection, and cement leakage, which can lead to nerve root irritation or compression. Rare but serious complications include osteomyelitis, spinal cord compression, and pulmonary embolism. These procedures are typically considered when conservative treatments fail to provide adequate pain relief.

What prior FDA approvals exist?

The FDA has approved several treatments for vertebral compression fractures (VCFs), particularly focusing on minimally invasive procedures such as vertebroplasty and kyphoplasty. Vertebroplasty involves the injection of polymethylmethacrylate (PMMA) bone cement into the fractured vertebra to stabilize it, while kyphoplasty includes an additional step of creating a cavity with a balloon before cement injection to restore vertebral height. These procedures aim to reduce pain and improve mobility in patients with VCFs. The AGN1 LOEP SV Kit, currently under study, is being compared to standard vertebroplasty using PMMA, indicating its potential as a similar minimally invasive treatment option.

What other types of research exist?

Promising novel alternatives to the AGN1 LOEP SV Kit for the treatment of vertebral compression fractures include: 1) Percutaneous Vertebroplasty (PVP) using polymethylmethacrylate (PMMA) bone cement, which has shown significant pain reduction and maintenance of vertebral height. 2) Hybrid constructs combining vertebral body augmentation with short pedicle screw fixation, which have demonstrated improvements in vertebral body height and segmental kyphosis without loss of correction. 3) Investigational use of recombinant human bone morphogenetic protein-2 (rhBMP-2) in spine fusion, which has shown potential in enhancing bone healing and stability.

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Medical Device

AGN1 LOEP SV Kit for VCFs (STAND Trial)

N/A

Recruiting

Led By Kern Singh

Research Sponsored by AgNovos Healthcare, LLC

Eligibility Criteria Checklist

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

Must have

Subject is a male or female aged 55 and 85 years, inclusive, of age at time of study treatment.

Subject has an Oswestry Disability Index (ODI) score of ≥ 30% at baseline.

Must not have

Subject has severe cardiopulmonary deficiencies.

Subject has a bleeding disorder.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new device called the AGN1 LOEP SV Kit for patients with painful spinal fractures. The device works by stabilizing the broken bone in the spine to reduce pain.

Who is the study for?

This trial is for men and women aged 55 to 85 with a single painful vertebral compression fracture (VCF) that hasn't healed within 6 months despite conservative treatments. Participants must have significant disability from the VCF, no high-energy trauma or tumor-related fractures, not be severely overweight, and have no major health issues like uncontrolled diabetes or severe heart/lung problems.

What is being tested?

The STAND trial is testing the AGN1 LOEP SV Kit against PMMA bone cement in treating vertebral compression fractures. It's a multicenter study where participants are randomly assigned to one of these treatments to see if AGN1 is just as safe and effective as the standard PMMA treatment.

What are the potential side effects?

While specific side effects aren't listed here, similar procedures may cause pain at the injection site, new fractures on adjacent vertebrae due to increased stiffness at the treated level, nerve damage resulting in numbness or tingling, bleeding, infection risks around the spine area.

Eligibility Criteria

Inclusion Criteria

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

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I am between 55 and 85 years old.

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My back pain significantly limits my daily activities.

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My back pain remains severe despite trying many treatments for over 6 weeks.

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I have been diagnosed with or am presumed to have osteoporosis.

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My imaging tests show that my vertebral compression fracture is recent or not healed.

Exclusion Criteria

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

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I have severe heart or lung problems.

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I have a bleeding disorder.

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My spine cannot safely support certain surgical tools.

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I have spinal issues causing nerve pain or problems in the area needing treatment.

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I have a disorder that affects how my body handles calcium.

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My spine condition is more severe than a mild slip.

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I have pain, weakness, or paralysis from a herniated disc or spinal narrowing.

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My kidney function is severely low.

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My blood clot is suspected to be caused by a tumor.

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I am currently being treated for an infection in my spine with antibiotics.

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I have a bone condition that is not osteoporosis.

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I need daily opioid painkillers for a condition not related to my vertebral compression fracture.

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I have nerve symptoms due to a spinal fracture.

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I have had tuberculosis of the spine.

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My spinal fracture is caused by bone tissue death.

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I have had surgery on my spine or near the target area before.

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I am taking medication that suppresses my immune system.

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I have diabetes that is not well-managed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, 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

Adverse events

Change in VCF-related Pain as measured by a 100 mm Visual Analogue Scale (VAS)

Change in function

+2 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: Treatment with AGN1 LOEP SV KitExperimental Treatment1 Intervention

The AGN1 LOEP SV Kit is intended for fixation of pathological fractures of the vertebral body using vertebral augmentation. Following saline lavage to create space, the AGN1 implant material is injected and hardens in situ to augment the fractured vertebral body. The AGN1 implant material is then resorbed and replaced with new bone.

Group II: Treatment with PMMA bone cementActive Control1 Intervention

High viscosity PMMA bone cement will be used for vertebral augmentation.

0 / 23Eligibility 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

The most common treatments for vertebral compression fractures (VCFs) include vertebroplasty and kyphoplasty. Both procedures involve the injection of bone cement (such as PMMA) into the fractured vertebra to stabilize it. Vertebroplasty directly injects the cement to provide immediate pain relief and stabilization, while kyphoplasty first uses a balloon to create a cavity and restore some vertebral height before cement injection. These treatments are crucial for VCF patients as they help reduce pain, improve mobility, and prevent further vertebral collapse. The AGN1 LOEP SV Kit, similar to these treatments, aims to provide minimally invasive stabilization, which is essential for reducing recovery time and improving patient outcomes.