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

Cervical Radiculopathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00344890
• Other study ID #: CR06-001
• Secondary ID: WIRB Protocol #2
• Status: Completed
• Phase: N/A
• First received: June 23, 2006
• Last updated: April 3, 2015
• Start date: September 2006
• Est. completion date: December 2012

Study information

• Verified date: April 2015
• Source: LifeNet Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Cervical Radiculopathy
• Myelopathy
• Radiculopathy

Intervention

Procedure:
• Anterior Cervical Discectomy and Fusion
1,2,3,or 4 level surgery

Locations

Country	Name	City	State
United States	VCU Medical Center	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
LifeNet Health

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.SP — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of subsidence		3 months post-op	No
Primary	Rate of fusion		6 months post-op	No