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

Not Applicable

Completed

• Conditions: Cervical Radiculopathy; Myelopathy
• Interventions: Procedure: Anterior Cervical Discectomy and Fusion

• Registration Number: NCT00344890
• Lead Sponsor: LifeNet Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-06-23
• Study First Submitted QC: 2006-06-23
• Study First Posted: 2006-06-27
• Study Start: 2006-09
• Primary Completion: 2011-12
• Study Completion: 2012-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-03
• Last Update Posted: 2015-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preservon	Anterior Cervical Discectomy and Fusion	-
Control	Anterior Cervical Discectomy and Fusion	-

Primary Outcome Measures

Name	Time	Method
Degree of subsidence	3 months post-op
Rate of fusion	6 months post-op

Trial Locations

Locations (1)

VCU Medical Center; 🇺🇸 Richmond, Virginia, United States