Baxter: Actifuse SHAPE vs DBX in ACC (NCT02005081) | Clinical Trial Compass
UnknownNot Applicable
Baxter: Actifuse SHAPE vs DBX in ACC
United States40 participantsStarted 2013-10
Plain-language summary
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).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 a…