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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
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 belowSelect...
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:Select...
I am currently on chemotherapy, radiation, or have been using steroids for more than 6 weeks in the past year.
Select...
I have a health condition that makes surgery too risky for me.
Select...
I have an infection in my body or at a recent surgery site.
Select...
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.
Select...
I have severe bone conditions or a very low bone density score.
Select...
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
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
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.
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.
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.
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Who is running the clinical trial?
Wayne State UniversityLead Sponsor
314 Previous Clinical Trials
110,048 Total Patients Enrolled
Hazem Eltahawy, MDPrincipal InvestigatorWayne State University, DMC
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently on chemotherapy, radiation, or have been using steroids for more than 6 weeks in the past year.My bones have finished growing.I have a health condition that makes surgery too risky for me.My back treatment didn’t work, and I need surgery to fuse my spine.I am not pregnant or nursing and agree to avoid pregnancy for 1 year after surgery.I have an infection in my body or at a recent surgery site.You are currently involved in a legal case related to a spinal injury and seeking permanent disability benefits.My spine has a condition where ligaments have turned into bone.You are allergic to titanium, stainless steel, polyurethane, polyethylene, or ethylene oxide residuals.I do not have conditions like severe osteoporosis or uncontrolled diabetes that affect bone healing.You are in jail when the study starts.I am on medication that could affect healing, like steroids.I have had a fracture in my spine, hip, or wrist due to osteoporosis.I am 18 years old or older and can legally consent.You have a condition that affects your ability to accurately assess your own physical or mental well-being.I am mentally and physically capable of following the study's requirements.I do not have any health conditions that would affect my recovery after surgery.You are extremely overweight with a body mass index over 40.I have severe bone conditions or a very low bone density score.I have an autoimmune disease or a systemic disorder like HIV.I have not had surgery on the specific spine levels affected.I have a condition like Paget's disease that affects bone health.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Autograft with Demineralized Bone Matrix
- Group 2: Actifuse SHAPE
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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