AGN1 LOEP SV Kit for VCFs

(STAND Trial)

Recruiting at 17 trial locations

Overseen By Allison Gorman

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: AgNovos Healthcare, LLC

Must not be taking: Opioids, Immune-suppressive drugs

Disqualifiers: Unstable VCF, Bleeding disorder, Infection, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you require daily opioid medication for pain not related to the target fractures, you may not be eligible to participate.

What data supports the effectiveness of the AGN1 LOEP SV Kit treatment for vertebral compression fractures?

Research shows that using polymethylmethacrylate (PMMA) bone cement, a component of the AGN1 LOEP SV Kit, can strengthen bones and reduce the risk of fractures in osteoporotic conditions. Studies have demonstrated that PMMA bone cement is effective in stabilizing osteoporotic compression fractures, which suggests potential benefits for vertebral compression fractures as well. ^{1 2 3 4 5}

Is the AGN1 LOEP SV Kit, also known as PMMA bone cement, safe for use in humans?

PMMA bone cement, used in various procedures, has been generally safe in humans, but there are potential side effects like thermal necrosis (tissue damage from heat) and cement leakage. In studies, no major complications were reported, and the use of contrast for visualization during procedures was effective. However, there is a risk of new fractures in nearby bones after treatment. ^{1 6 7 8 9}

What makes the AGN1 LOEP SV Kit treatment unique for vertebral compression fractures?

The AGN1 LOEP SV Kit uses a small volume of PMMA bone cement, which is designed to enhance bone strength while minimizing risks like thermal damage and cement leakage, thanks to patient-specific planning and computer-assisted techniques. ^{1 2 10 11 12}

Research Team

Kern Singh

Principal Investigator

Midwest Orthopedics at Rush

Eligibility Criteria

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.

Inclusion Criteria

I am between 55 and 85 years old.

My pain from vertebral compression fractures has been for 6 months or less.

My spine is tender at the site of my vertebral fracture, confirmed by an exam.

Exclusion Criteria

I have severe heart or lung problems.

Subject is currently enrolled in another interventional clinical study.

Target VCF is due to high-energy trauma.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive vertebral augmentation using either the AGN1 LOEP SV Kit or PMMA bone cement

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

5 visits (in-person) at 7 days, 28 days, 3 months, 12 months, and 24 months

Treatment Details

Interventions

• AGN1 LOEP SV Kit (Medical Device)
• PMMA bone cement (Bone Cement)

Trial Overview 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.

Participant Groups

Group I: Treatment with AGN1 LOEP SV Kit Experimental Treatment 1 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 cement Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

AgNovos Healthcare, LLC

Lead Sponsor

Trials

9

Recruited

3,200+

Findings from Research

Using subject-specific planning and computer-assisted techniques to augment osteoporotic femora with PMMA bone cement significantly increased bone strength, with yield load increasing by 33% and maximum load by 30%.

The method minimized the amount of cement used (average of 9.5 ml) while effectively reducing the risk of hip fractures, demonstrating a promising approach to enhance bone stability without the common side effects associated with excessive cement use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subject-specific planning of femoroplasty: an experimental verification study. Basafa, E., Murphy, RJ., Otake, Y., et al.[2022]

In a review of 13 randomized controlled trials with 1949 participants, bone cement augmentation for osteoporotic vertebral compression fractures did not significantly increase the incidence of new vertebral fractures during short-term follow-ups (6 and 12 months).

However, over a longer follow-up period of 24 months or more, patients receiving bone cement augmentation had a significantly lower incidence of new vertebral fractures compared to non-bone cement treatments, although they experienced a higher risk of new adjacent vertebral fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association Between Bone Cement Augmentation and New Vertebral Fractures in Patients with Osteoporotic Vertebral Compression Fractures: A Systematic Review and Meta-Analysis. Xiao, Q., Zhao, Y., Qu, Z., et al.[2021]

In a study of 62 osteoporosis patients undergoing anterior lumbar interbody fusion (ALIF), the use of PMMA cement augmentation significantly reduced cage subsidence (5.2% in the PMMA group vs. 19.6% in the control group) and vertebral body height loss (3.9% vs. 10.7%).

The addition of PMMA augmentation did not increase the rates of nonunion or adjacent-segment degeneration, suggesting it is a safe and effective method to enhance the stability of ALIF in osteoporotic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anterior bone cement augmentation in anterior lumbar interbody fusion and percutaneous pedicle screw fixation in patients with osteoporosis. Kim, KH., Lee, SH., Lee, DY., et al.[2022]

Cement augmentation during posterior spinal fusion (PSF) significantly reduces the incidence of screw loosening and other complications in patients with low bone density, with only 5.41% experiencing screw loosening compared to higher rates in unaugmented patients.

Patients with low bone density who received cement augmentation (Group II-B) showed similar pain relief and clinical outcomes as those with normal bone density, indicating that cement augmentation is an effective strategy for improving surgical outcomes in low-density bones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pedicle Screw Fixation With Cement Augmentation Versus Without in the Treatment of Spinal Stenosis Following Posterior Spinal Fusion Surgery, Superiority According to Bone Mineral Density: A Three-Arm Randomized Clinical Trial. Shafiekhani, P., Darabi, M., Jajin, EA., et al.[2023]

In a study involving 32 lumbar vertebral levels, it was found that latex or air injected into the lumbar vertebrae could flow into the inferior vena cava, highlighting the risk of cement extrusion during procedures involving polymethylmethacrylate for stabilizing osteoporotic fractures.

The research confirmed that while latex or air could enter the inferior vena cava, it did not enter the spinal canal, emphasizing the importance of understanding lumbar vertebral venous anatomy to prevent complications during surgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Venous Drainage of Lumbar Vertebral Bodies: Anatomic Study with Application to Kyphoplasty, Vertebroplasty, and Pedicle Screw Complications. Iwanaga, J., Rustagi, T., Ishak, B., et al.[2020]

In a study of 63 patients over 80 years old with osteoporotic vertebral compression fractures, the new bone cement made from mineralized collagen and PMMA (MC-PMMA) showed comparable short-term outcomes to traditional PMMA cement in terms of pain relief and functional improvement.

However, 12 months post-surgery, the MC-PMMA group demonstrated superior long-term benefits, suggesting that this new bone cement may provide better overall clinical outcomes for elderly patients with these types of fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Poly(methyl methacrylate) bone cement composited with mineralized collagen for osteoporotic vertebral compression fractures in extremely old patients. Luo, K., Jiang, G., Zhu, J., et al.[2020]

A new mixing regimen for bone cement and iodinated contrast used in percutaneous vertebroplasty (PVP) was developed, allowing for proper fluoroscopic visualization during procedures without major complications in 125 patients.

While the addition of contrast reduced the ultimate compressive strength of the cement mixture by 38%, this change did not significantly impact clinical outcomes, with 64% of patients achieving complete response and no vertebral collapse during follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A simplified method of opacifying and mixing acrylic cement for percutaneous vertebroplasty: a clinical and in vitro study. Teng, GJ., He, SC., Deng, G., et al.[2019]

In a study of 191 patients with osteoporotic vertebral fractures treated with percutaneous kyphoplasty, using acrylic cement (PMMA) mixed with calcium sulfate showed equivalent pain relief and functional improvement compared to pure PMMA.

The combination of PMMA and calcium sulfate significantly reduced the risk of cement leakage during the procedure, enhancing the safety of the treatment without compromising efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of acrylic bone cement mixed with calcium sulfate combined with percutaneous kyphoplasty in the treatment of osteoporotic fractures]. Fu, Y., Yan, YC., Ru, XL., et al.[2023]

In a study of 98 patients with osteoporosis, the extent of polymethylmethacrylate cement used in vertebroplasty was found to correlate with the risk of new fractures in adjacent vertebral bodies, with a follow-up period averaging about 2 years.

Specifically, the risk of adjacent vertebral fractures was highest when the cement was placed at the disc level (44% of cases), compared to 29% at the endplate level and only 7% at the trabecula level, suggesting that careful placement of cement could help reduce fracture risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of post-vertebroplasty fracture in adjacent vertebral bodies appears correlated with the morphologic extent of bone cement. Sun, YC., Teng, MM., Yuan, WS., et al.[2019]

The Confidence high viscosity bone cement system, combined with postural reduction, effectively treated acute severe osteoporotic vertebral compression fractures in 34 patients, achieving complete pain relief in 31 cases and significant improvements in vertebral height and alignment.

The procedure demonstrated a low complication rate, with only 8.8% experiencing cement leakage, none of which resulted in clinical symptoms, indicating a safe intervention for elderly patients with osteoporosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Confidence high viscosity bone cement system and postural reduction in treating acute severe osteoporotic vertebral compression fractures]. Li, B., Wang, Q., Yu, Y., et al.[2019]

In a study of 56 elderly patients with osteoporotic vertebral compression fractures, the use of high viscosity bone cement for targeted sealing followed by low viscosity cement injection significantly reduced pain, with VAS scores dropping from an average of 7.21 to 2.81 within three days post-operation.

The technique demonstrated a low incidence of bone cement leakage (3.57%), with no significant clinical symptoms reported, indicating improved safety during vertebroplasty procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical application of targeted sealing with high viscosity bone cement and secondary injection of low viscosity bone cement in vertebroplasty]. Liu, CZ., Jia, BX., Gao, XQ., et al.[2023]

In a study of 160 elderly patients with osteoporotic vertebral compression fractures, types I, II, and III bone cement distributions during percutaneous vertebroplasty (PVP) resulted in significantly better pain relief and functional outcomes compared to types IV and V, both three days and one year post-surgery.

Patients with types I, II, and III distributions experienced lower rates of refractures and adjacent vertebral fractures, indicating that even distribution of bone cement is crucial for long-term clinical efficacy following PVP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of cement distribution type on clinical outcome after percutaneous vertebroplasty for osteoporotic vertebral compression fractures in the aging population. Zhou, C., Liao, Y., Huang, S., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Subject-specific planning of femoroplasty: an experimental verification study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Association Between Bone Cement Augmentation and New Vertebral Fractures in Patients with Osteoporotic Vertebral Compression Fractures: A Systematic Review and Meta-Analysis. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Anterior bone cement augmentation in anterior lumbar interbody fusion and percutaneous pedicle screw fixation in patients with osteoporosis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Pedicle Screw Fixation With Cement Augmentation Versus Without in the Treatment of Spinal Stenosis Following Posterior Spinal Fusion Surgery, Superiority According to Bone Mineral Density: A Three-Arm Randomized Clinical Trial. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Venous Drainage of Lumbar Vertebral Bodies: Anatomic Study with Application to Kyphoplasty, Vertebroplasty, and Pedicle Screw Complications. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Poly(methyl methacrylate) bone cement composited with mineralized collagen for osteoporotic vertebral compression fractures in extremely old patients. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

A simplified method of opacifying and mixing acrylic cement for percutaneous vertebroplasty: a clinical and in vitro study. [2019]

8. China pubmed.ncbi.nlm.nih.gov

[Effect of acrylic bone cement mixed with calcium sulfate combined with percutaneous kyphoplasty in the treatment of osteoporotic fractures]. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Risk of post-vertebroplasty fracture in adjacent vertebral bodies appears correlated with the morphologic extent of bone cement. [2019]

10. China pubmed.ncbi.nlm.nih.gov

[Confidence high viscosity bone cement system and postural reduction in treating acute severe osteoporotic vertebral compression fractures]. [2019]

11. China pubmed.ncbi.nlm.nih.gov

[Clinical application of targeted sealing with high viscosity bone cement and secondary injection of low viscosity bone cement in vertebroplasty]. [2023]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of cement distribution type on clinical outcome after percutaneous vertebroplasty for osteoporotic vertebral compression fractures in the aging population. [2022]