Safety Study of Preservon-Treated Bone Implants for Cervical Fusion in the Treatment of Cervical Radiculopathy or Myelopathy

Completed · Not applicable

Conditions studied: Cervical Radiculopathy, Myelopathy

In brief

The purpose of this study is to compare the safety and efficacy of Preservon(TM) treated allograft bone dowels to traditional freeze-dried allograft bone dowels (control) for fusion of degenerated cervical intervertebral discs in the treatment of cervical radiculopathy or myelopathy. Patient follow-up will be conducted at 6 weeks, 3 months, and 6 months. At 3 months after surgery, the implanted bone dowels will be assessed for subsidence; at 6 months after surgery, the implanted bone dowels will be assessed for fusion. Patients will complete questionnaires and x-rays taken at each visit. The degree of subsidence and rate of fusion will be assessed based on the evaluation of the x-rays taken. The x-ray evaluation will be conducted by a neurosurgeon who is blinded to the type of treatment that each patient has received.

Key facts

Study ID

NCT00344890

Run by

LifeNet Health

People needed

106

Starts

2006-09-01

Expected to finish

2012-12-01

Last updated by the study team

2015-04-07

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is skeletally mature
• Patient has confirmed radiculopathy or myelopathy
• Pain unresponsive to non-operative treatment
• Radicular pain in either or both upper extremities
• Neurological deficit in distribution of nerve root from C3/4 to C6/7
• Patient's lateral cervical spine x-rays show inferior aspect of lowest vertebral body to be fused
• Patient agrees to comply with protocol
• Patient can provide voluntary informed consent and follow-up information

You may not qualify if…

• Patient has previous cervical spine surgery
• Patient requires concurrent posterior surgery at level to be treated, or anterior and posterior surgery at any other cervical level
• Patient has clinically compromised vertebral body structure
• Patient has multi-level fixed/ankylosed cervical spine
• Patient has signs of significant instability at level to be treated or adjacent level
• Patient has history of metabolic bone disease
• Patient is taking chronic oral/IV corticosteroid therapy OR medications that potentially interfere with bone/soft tissue healing
• Patient has progressive neuromuscular disease, rheumatoid arthritis, active malignancy, OR any other condition that interferes with self-assessment of pain, function, or quality of life
• Patient has OPLL at any level
• Patient has active infection, local or systemic
• Patient is pregnant or considering pregnancy (x-ray requirements)
• Patient is participating in another investigational study
• Patient belongs to vulnerable population

Where it is running

• VCU Medical Center — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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