Recruiting

Actifuse SHAPE vs. DBX

Sponsor:

Wayne State University

Code:

NCT02005081

Conditions

Cervical Spine Degenerative Disease Nos

Cervical Spondylosis With Myelopathy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Actifuse SHAPE

Autograft with Demineralized Bone Matrix

Study Details

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

Study ID

NCT02005081

Start date

Oct, 2013

Status verified date

Dec, 2013

Primary completion date

Oct, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: 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.

other: Autograft with Demineralized Bone Matrix

autograft mixed with demineralized bone matrix in cervical spine fusion.

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.

Autograft with Demineralized Bone Matrix

autograft mixed with demineralized bone matrix in cervical spine fusion.

Primary outcome measure

  • Change in Fusion Rates [ Time Frame: Baseline, 6 weeks, 6 months, 12 months, 24 months ]

Central Contacts and Locations

Central contacts

Erica J Harris, MS

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

Diana Scanlon, RN, NP

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

Locations

Wayne State University

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Erica J Harris, MS

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

Diana Scanlon, RN, NP

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

Principal Investigator:

Hazem Eltahawy, MD

More Information

Sponsor

Wayne State University

Last update posted

Dec 9, 2013

Last verified

Dec, 2013

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wayne State University on 2013-12-09.