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

NCT ID: NCT00344890

Last Updated: 2015-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2012-12-31

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.

Conditions

Cervical Radiculopathy; Myelopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Preservon

Group Type: EXPERIMENTAL

Anterior Cervical Discectomy and Fusion

Intervention Type: PROCEDURE

1,2,3,or 4 level surgery

Control

Group Type: ACTIVE_COMPARATOR

Anterior Cervical Discectomy and Fusion

Intervention Type: PROCEDURE

1,2,3,or 4 level surgery

Interventions

Anterior Cervical Discectomy and Fusion

1,2,3,or 4 level surgery

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LifeNet Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bruce E. Mathern, M.D.

Role: PRINCIPAL_INVESTIGATOR

VCU Medical Center

Locations

VCU Medical Center

Richmond, Virginia, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 25360528 (View on PubMed)

Other Identifiers

WIRB Protocol #20061453

Identifier Type: -

Identifier Source: secondary_id

CR06-001

Identifier Type: -

Identifier Source: org_study_id