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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 weeks, 6 months, 12 months, 24 months
Awards & highlights
Study Summary
This trial is testing whether a commercially available bone graft substitute works as well as bone marrow aspirate and autograft for anterior cervical corpectomy in patients with cervical spondylotic myelopathy.
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.Check my eligibility
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.See study design
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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Fusion Rates
Secondary outcome measures
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.
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Who is running the clinical trial?
Wayne State UniversityLead Sponsor
307 Previous Clinical Trials
108,424 Total Patients Enrolled
Hazem Eltahawy, MDPrincipal InvestigatorWayne State University, DMC
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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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I eligible to participate in this investigation?
"This research endeavours to enroll 40 participants, ranging from the age of majority up to 75 years old. Participants are required to meet various criteria such as: having gone through conservative treatment and being eligible for spinal fusion surgery; not nursing or pregnant (or amenable to abstaining from pregnancy in the year after surgery); skeletally mature; and no previous surgical procedures at related levels."
Answered by AI
Are participants over the age of 80 eligible to join this medical experiment?
"This clinical trial is open to individuals who are over 18 years old, but not more than 75."
Answered by AI
Could new participants still join this experiment?
"Clinicaltrials.gov reveals that this medical trial, which was first posted on October 1st 2013 and last updated December 3rd 2013, is no longer looking for candidates. However, there are an additional 56 trials recruiting patients at the moment."
Answered by AI
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