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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- LifeNet Health
- Enrollment
- 106
- Locations
- 2
- Primary Endpoint
- Degree of subsidence
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Degree of subsidence
Time Frame: 3 months post-op
Rate of fusion
Time Frame: 6 months post-op
Secondary Outcomes
No secondary outcomes reported