Baxter: Actifuse SHAPE vs DBX in ACC

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Wayne State University
Sponsor:
Information provided by (Responsible Party):
Hazem Eltahawy MD, Wayne State University
ClinicalTrials.gov Identifier:
NCT02005081
First received: November 1, 2013
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

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).


Condition Intervention
Cervical Spine Degenerative Disease Nos
Cervical Spondylosis With Myelopathy
Device: Actifuse SHAPE
Device: Autograft with Demineralized Bone Matrix

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective Study Using Actifuse SHAPE Versus Autograft With Demineralized Bone Matrix to Achieve Bone Fusion in Anterior Cervical Corpectomy (ACC)

Resource links provided by NLM:


Further study details as provided by Wayne State University:

Primary Outcome Measures:
  • Change in Fusion Rates [ Time Frame: Baseline, 6 weeks, 6 months, 12 months, 24 months ] [ Designated as safety issue: Yes ]

    2 or 4 view x-rays (Lateral, Flexion, Extension, Anteroposterior)at 6 weeks, 6 months, 12 months and 24 months CT scan at 12 months and 24 months Radiographic Fusion Success is defined as evidence of:Bridging trabecular bone on two contiguous segments in two or three planes (axial, sagittal, or coronal),Translational motion less than 3 mm as measured on flexion/extension films,Angular motion less than 3 degrees as measured on flexion/extension films Note: For multi level fusions, all levels must be fused according to the above criteria.

    Reported at study completion.



Secondary Outcome Measures:
  • Change in Clinical Outcomes [ Time Frame: Baseline, 6 weeks, 6 months, 12 months and 24 months ] [ Designated as safety issue: Yes ]

    Pain/Function Disability Subjects must exhibit an improvement compared to their preoperative scores in the following measures to be considered a success:Neck Disability Index (NDI),Visual Analogue Scale (VAS),Quality of Life (SF-36v2 - 1 week recall)

    Reported at study completion.


  • Change in Clinical Outcomes [ Time Frame: Baseline, 6 weeks, 6 months, 12 months, 24 months ] [ Designated as safety issue: Yes ]

    Neurological Status Subjects will be considered to be a neurological success if they experience maintenance or improvement of their neurological status when compared to baseline scores.

    Reported at study completion.



Estimated Enrollment: 40
Study Start Date: October 2013
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Actifuse SHAPE
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.
Device: Actifuse SHAPE
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.
Autograft with Demineralized Bone Matrix
autograft mixed with demineralized bone matrix in cervical spine fusion.
Device: Autograft with Demineralized Bone Matrix
autograft mixed with demineralized bone matrix in cervical spine fusion.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02005081

Contacts
Contact: Erica J Harris, MS 313-966-7218 eharri@med.wayne.edu
Contact: Diana Scanlon, RN, NP 313-745-7131 dscanlon@med.wayne.edu

Locations
United States, Michigan
Wayne State University Recruiting
Detroit, Michigan, United States, 48201
Contact: Erica J Harris, MS    313-966-7218    eharri@med.wayne.edu   
Contact: Diana Scanlon, RN, NP    313-745-7131    dscanlon@med.wayne.edu   
Principal Investigator: Hazem Eltahawy, MD         
Sponsors and Collaborators
Wayne State University
Investigators
Principal Investigator: Hazem Eltahawy, MD Wayne State University, DMC
  More Information

No publications provided

Responsible Party: Hazem Eltahawy MD, Assistant Professor, Neurosurgeon, Wayne State University
ClinicalTrials.gov Identifier: NCT02005081     History of Changes
Other Study ID Numbers: Baxter
Study First Received: November 1, 2013
Last Updated: December 3, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bone Marrow Diseases
Spinal Cord Diseases
Spondylosis
Spinal Osteophytosis
Hematologic Diseases
Central Nervous System Diseases
Nervous System Diseases
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 19, 2014