What is the mechanism of action of this treatment?

The most common treatments for Cervical Spondylosis, such as Actifuse mixed with bone marrow aspirate (BMA) and Autograft mixed with demineralized bone matrix (DBM), work by promoting bone regeneration and spinal fusion. Actifuse, a synthetic bone graft substitute, provides a scaffold for new bone growth, and when combined with BMA, which contains stem cells and growth factors, it enhances the bone healing process. Autograft uses the patient's own bone, ensuring compatibility and containing living cells that aid in healing. When mixed with DBM, which has proteins that stimulate bone growth, it further supports bone regeneration. These treatments are essential for stabilizing the spine and alleviating symptoms in Cervical Spondylosis patients by ensuring effective bone healing and spinal fusion.

What side effects are associated with this type of intervention?

Common treatments for Cervical Spondylosis, such as Actifuse mixed with bone marrow aspirate (BMA) and Autograft mixed with demineralized bone matrix (DBM), have specific side effects. Actifuse with BMA may cause local inflammation, infection, and pain at the graft site. There is also a risk of immune reaction to the synthetic material. Autografts can lead to donor site pain, infection, and potential complications at the harvest site. DBM, while generally safe, can sometimes cause allergic reactions or transmission of diseases if not properly processed. Both treatments aim to promote bone growth but carry risks typical of surgical interventions, including bleeding and nerve damage.

What prior FDA approvals exist?

The FDA has approved various treatments for Cervical Spondylosis that involve bone graft substitutes and regenerative techniques. Treatments similar to Actifuse mixed with bone marrow aspirate (BMA) include synthetic bone graft substitutes like Actifuse, which promote bone growth, and the use of bone marrow aspirate containing stem cells and growth factors. For treatments akin to Autograft mixed with demineralized bone matrix (DBM), the FDA has approved the use of autografts, where bone is taken from the patient's own body, and demineralized bone matrix, which is processed bone containing proteins that stimulate bone growth. These treatments aim to enhance bone regeneration and fusion in spinal surgeries.

What other types of research exist?

Promising novel alternatives for cervical spondylosis treatment in 2024 include: 1) Stem cell therapy using allogeneic mesenchymal stem cells (MSCs), which have shown potential in promoting bone healing and reducing complications. 2) Advanced synthetic bone grafts like bioactive glass or ceramics that enhance osteointegration and bone regeneration. 3) Growth factor-enhanced scaffolds, which combine synthetic materials with biological agents to stimulate bone growth more effectively.

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Bone Graft Substitute

Actifuse SHAPE vs Autograft for Spinal Cord Disease

N/A

Waitlist Available

Led By Hazem Eltahawy, MD

Research Sponsored by Wayne State University

Eligibility Criteria Checklist

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

Must have

The subject is skeletally mature (epiphyses closed)

The subject has failed conservative treatment and is a candidate for spinal fusion surgery

Must not have

Undergoing chemotherapy or radiation treatment, or chronic use of steroids (defined as more than 6 weeks of steroid use within 12 months of surgery, other than episodic use or inhaled corticosteroids)

Subject has a concurrent disease process that would place the subject in excessive risk to surgery (i.e. significant circulatory or pulmonary problems, or significant cardiac disease)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 weeks, 6 months, 12 months, 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two types of bone grafts used in neck surgery for patients with severe spinal conditions. One uses a synthetic material combined with the patient's bone marrow, while the other uses the patient's own bone mixed with processed bone material. These grafts help new bone grow and stabilize the spine, reducing pain and improving function.

Who is the study for?

This trial is for adults over 18 who need spinal fusion surgery due to cervical spondylosis and haven't improved with other treatments. They must be able to follow the study plan, attend follow-ups, and not be pregnant or planning pregnancy for a year post-surgery. Exclusions include infection, substance abuse history, involvement in another study that affects results, certain bone diseases or allergies, severe obesity, legal issues related to spine conditions, excessive surgical risk factors like heart or lung disease.

What is being tested?

The trial is testing two types of bone graft substitutes in patients undergoing anterior cervical corpectomy (ACC) spinal fusion: Actifuse mixed with bone marrow aspirate versus autograft mixed with demineralized bone matrix. It aims to compare their effectiveness in achieving spinal fusion and improving clinical outcomes over a period of two years.

What are the potential side effects?

Potential side effects may relate to the surgical procedure itself such as pain at the graft site, infection risks associated with surgery and anesthesia complications. Specific side effects from Actifuse SHAPE or DBX are not detailed but could include reactions at the implantation site or issues related to bone healing.

Eligibility Criteria

Inclusion Criteria

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

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My bones have finished growing.

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My back treatment didn’t work, and I need surgery to fuse my spine.

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I am 18 years old or older and can legally consent.

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I have not had surgery on the specific spine levels affected.

Exclusion Criteria

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

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I am currently on chemotherapy, radiation, or have been using steroids for more than 6 weeks in the past year.

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I have a health condition that makes surgery too risky for me.

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I have an infection in my body or at a recent surgery site.

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My spine has a condition where ligaments have turned into bone.

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I do not have conditions like severe osteoporosis or uncontrolled diabetes that affect bone healing.

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I have had a fracture in my spine, hip, or wrist due to osteoporosis.

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I do not have any health conditions that would affect my recovery after surgery.

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I have severe bone conditions or a very low bone density score.

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I have a condition like Paget's disease that affects bone health.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 weeks, 6 months, 12 months, 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 weeks, 6 months, 12 months, 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 weeks, 6 months, 12 months, 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

Change in Fusion Rates

Secondary study objectives

Change in Clinical Outcomes

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

Group I: Autograft with Demineralized Bone MatrixExperimental Treatment1 Intervention

autograft mixed with demineralized bone matrix in cervical spine fusion.

Group II: Actifuse SHAPEExperimental Treatment1 Intervention

Actifuse Synthetic Bone Graft substitutes mixed with bone marrow aspirate in cervical spine fusion. Actifuse is a synthetic, porous, silicate-substituted hydroxyapatite and has shown that this maximizes a favorable bony response.

0 / 13Eligibility 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 Cervical Spondylosis, such as Actifuse mixed with bone marrow aspirate (BMA) and Autograft mixed with demineralized bone matrix (DBM), work by promoting bone regeneration and spinal fusion. Actifuse, a synthetic bone graft substitute, provides a scaffold for new bone growth, and when combined with BMA, which contains stem cells and growth factors, it enhances the bone healing process. Autograft uses the patient's own bone, ensuring compatibility and containing living cells that aid in healing. When mixed with DBM, which has proteins that stimulate bone growth, it further supports bone regeneration. These treatments are essential for stabilizing the spine and alleviating symptoms in Cervical Spondylosis patients by ensuring effective bone healing and spinal fusion.

Combined macromolecule biomaterials together with fluid shear stress promote the osteogenic differentiation capacity of equine adipose-derived mesenchymal stem cells.Osteoinductive Activity of Selected Demineralized Bone Matrix Products from Donors of Different Ages.Low-dose BMP-2 is sufficient to enhance the bone formation induced by an injectable, PLGA fiber-reinforced, brushite-forming cement in a sheep defect model of lumbar osteopenia.