Baxter: Actifuse SHAPE vs DBX in ACC

NCT02005081 | Unknown DMC

• 1 other identifier: Baxter
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Cervical Spine Degenerative Disease Nos; Cervical Spondylosis With Myelopathy

Outcome Measures

Primary Outcomes (1)

• Change in Fusion Rates

  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.

  Baseline, 6 weeks, 6 months, 12 months, 24 months

Secondary Outcomes (2)

• Change in Clinical Outcomes

  Baseline, 6 weeks, 6 months, 12 months and 24 months

• Change in Clinical Outcomes

  Baseline, 6 weeks, 6 months, 12 months, 24 months

Study Arms (2)

Actifuse SHAPE

OTHER

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

Autograft with Demineralized Bone Matrix

OTHER

autograft mixed with demineralized bone matrix in cervical spine fusion.

Device: Autograft with Demineralized Bone Matrix

Interventions

Actifuse SHAPE DEVICE

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.

Actifuse SHAPE

Autograft with Demineralized Bone Matrix DEVICE

autograft mixed with demineralized bone matrix in cervical spine fusion.

Autograft with Demineralized Bone Matrix

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

Wayne State University

Detroit, Michigan, 48201, United States

RECRUITING

MeSH Terms

Interventions

Transplantation, Autologous

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Officials

• Hazem Eltahawy, MD

  Wayne State University, DMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erica J Harris, MS

CONTACT

313-966-7218; eharri@med.wayne.edu

Diana Scanlon, RN, NP

CONTACT

313-745-7131; dscanlon@med.wayne.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Neurosurgeon

Study Record Dates

• First Submitted: November 1, 2013
• First Posted: December 9, 2013
• Study Start: October 1, 2013
• Primary Completion: October 1, 2017
• Last Updated: December 9, 2013

Record last verified: 2013-12

Locations

US (1)