Clinical trial NCT00344890: Safety Study of Preservon-Treated Bone Implants for Cervical Fusion in the Treatment of Cervical Radiculopathy or Myelopathy
Official title: A Safety and Efficacy Comparison of Preservon Treated Allograft Bone Dowels Versus Traditional Freeze-Dried Allograft Bone Dowels for Fusion of Degenerated Cervical Intervertebral Discs in the Treatment of Cervical Radiculopathy or Myelopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Radiculopathy
Myelopathy
Keywords: Cervical fusion
Anterior Cervical Discectomy and Fusion
ACDF
Lead sponsor: LifeNet Health
Sponsor class: INDUSTRY
First posted: 2006-06-27
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Degree of subsidence
timeFrame: 3 months post-op
measure: Rate of fusion
timeFrame: 6 months post-op
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: VCU Medical Center
state: Virginia
Study officials:
affiliation: VCU Medical Center
name: Bruce E. Mathern, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Graham RS, Samsell BJ, Proffer A, Moore MA, Vega RA, Stary JM, Mathern B. Evaluation of glycerol-preserved bone allografts in cervical spine fusion: a prospective, randomized controlled trial. J Neurosurg Spine. 2015 Jan;22(1):1-10. doi: 10.3171/2014.9.SPINE131005.