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

LifeNet Health

Status

Completed

Conditions

Myelopathy

Cervical Radiculopathy

Treatments

Procedure: Anterior Cervical Discectomy and Fusion

Study type

Interventional

Funder types

Industry

Identifiers

NCT00344890

WIRB Protocol #20061453

CR06-001

Details and patient eligibility

About

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.

Enrollment

106 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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