Clinical Trial: Baxter: Actifuse SHAPE vs DBX in ACC

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Prospective Study Using Actifuse SHAPE Versus Autograft With Demineralized Bone Matrix to Achieve Bone Fusion in Anterior Cervical Corpectomy (ACC)

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).

Detailed Summary:

Background Fusion of the spine was introduced in 1911 for the management of deformity and is currently used to relieve pain and restore function in patients diagnosed with degenerative disc disease. Degenerative conditions of the spine resulting in functionally limiting back pain or neck, and arm pain with or without extremity pain and dysfunction are a major problem in today's world. Recommended treatment for these conditions can vary initially from bed rest, exercise, traction, manipulation and drug therapy to eventual surgery.

One of the most common neck conditions that occurs among people older than 50 years is cervical spondylotic myelopathy (CSM). This may produce symptoms of cervical radiculopathy, myelopathy, or both. Over time, the normal wear-and-tear effects of aging can lead to a narrowing of the spinal canal. This compresses or squeezes the spinal cord. CSM can cause a variety of symptoms, including pain, numbness, and weakness. When patients with degenerative cervical disease require surgery, an anterior decompression of the neural elements and reconstruction of the anterior column with allograft, bone graft substitutes or autograft is common. These types of reconstruction surgery can be referred to as Spinal fusion. The objective of spinal fusion is to eliminate motion of the vertebral body and thereby relieve pain.

An anterior cervical corpectomy, fusion and instrumentation, is usually performed for patients who have pressure on their nerves or spinal cord in their neck. This pressure can lead to pain, weakness or numbness in the arms and occasionally in the legs as well. If non-operative treatment such as medications and therapy are ineffective, patients may require surgery in order to relieve the pressure off their spinal cord and nerves.

Anterior cervical
Sponsor: Wayne State University

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

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.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in Clinical Outcomes [ Time Frame: Baseline, 6 weeks, 6 months, 12 months and 24 months ]

    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 ]

    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.



Original Secondary Outcome: Same as current

Information By: Wayne State University

Dates:
Date Received: November 1, 2013
Date Started: October 2013
Date Completion:
Last Updated: December 3, 2013
Last Verified: December 2013