Baxter: Actifuse SHAPE vs DBX in ACC

Status unconfirmed · Not applicable

Conditions studied: Cervical Spine Degenerative Disease Nos, Cervical Spondylosis With Myelopathy

In brief

The purpose of this single-center, prospective, randomized study is to determine the fusion rates along with the clinical outcomes of commercially available bone graft substitutes Actifuse mixed with bone marrow aspirate (BMA) versus autograft mixed with demineralized bone matrix (DBM), in subjects who require anterior cervical corpectomy (ACC) spinal fusion in patients experiencing cervical spondylotic myelopathy (CSM).

Key facts

Study ID

NCT02005081

Run by

Wayne State University

People needed

40

Starts

2013-10-01

Last updated by the study team

2013-12-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The subject has failed conservative treatment and is a candidate for spinal fusion surgery.
• The subject is ≥18 years old and of legal age of consent.
• The subject is, in the investigator's opinion, psychosocially, mentally, and physically able to fully comply with this protocol, including the post-operative regimen, attend the required follow-up visits, completion of required forms, and be able to understand and provide written informed consent.
• The subject is skeletally mature (epiphyses closed).
• The subject has voluntarily signed the approved informed consent.
• The subject is willing and able to participate in post-operative clinical and radiographic follow up evaluations for 2 years.
• No previous surgical intervention at the involved fusion level(s);
• Women of child-bearing potential must not be pregnant or nursing, and agrees to not get pregnant for 1 year following surgery

You may not qualify if…

• Subject has systemic infection or infection at the surgical site.
• Subject has a medical condition that would interfere with post-operative assessments and care (i.e., metabolic bone disease, neuromuscular disease, autoimmune disease, active malignancy, psychiatric disease, paraplegia, quadriplegia, etc.).
• 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).
• Subject has a history (present or past) of substance abuse (recreational drugs, prescription drugs or alcohol) that in the investigator's opinion may interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up.
• The subject is pregnant/breastfeeding at the time of enrollment, or plans to become pregnant during the course of the study.
• Subject is participating in another clinical study, which could confound results.
• Subject has ossification of posterior longitudinal ligament (OPLL) at any level
• History of an osteoporotic fracture of the spine, hip or wrist
• History of an endocrine or metabolic disorder (e.g., Paget's disease) known to affect bone and mineral metabolism
• Taking medications that may interfere with bony/soft tissue healing including chronic steroid use
• Known allergy to titanium, stainless steels, polyurethane, polyethylene, or ethylene oxide residuals
• Rheumatoid arthritis or other known autoimmune disease or known to have a systemic disorder such as HIV, active hepatitis B or C or fibromyalgia
• Severe obesity (Body Mass Index > 40)
• Physical or mental condition (e.g., psychiatric disorder, senile dementia, Alzheimer's disease, alcohol or drug addiction) that would interfere with patient self-assessment of function, pain or quality of life.
• Involved in current or pending spinal litigation where permanent disability benefits are being sought
• Incarcerated at the time of study enrollment
• Diseases that significantly inhibit bone healing (osteoporosis, metabolic bone disease, uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease)
• 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 severe osteopenia, osteoporosis, osteomalacia, spinal metastases, or metabolic bone disease that would significantly inhibit bone healing OR the level of BMD is a T score of -2.5 or below OR patient has sustained a vertebral compression or nontraumatic hip or wrist fracture.

Where it is running

• Wayne State University — Detroit, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

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