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

Primary Purpose

Cervical Radiculopathy, Myelopathy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anterior Cervical Discectomy and Fusion
Sponsored by
LifeNet Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Radiculopathy focused on measuring Cervical fusion, Anterior Cervical Discectomy and Fusion, ACDF

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • VCU Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Preservon

Control

Arm Description

Outcomes

Primary Outcome Measures

Degree of subsidence
Rate of fusion

Secondary Outcome Measures

Full Information

First Posted
June 23, 2006
Last Updated
April 3, 2015
Sponsor
LifeNet Health
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1. Study Identification

Unique Protocol Identification Number
NCT00344890
Brief Title
Safety Study of Preservon-Treated Bone Implants for Cervical Fusion in the Treatment of Cervical Radiculopathy or Myelopathy
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LifeNet Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Radiculopathy, Myelopathy
Keywords
Cervical fusion, Anterior Cervical Discectomy and Fusion, ACDF

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Preservon
Arm Type
Experimental
Arm Title
Control
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Anterior Cervical Discectomy and Fusion
Intervention Description
1,2,3,or 4 level surgery
Primary Outcome Measure Information:
Title
Degree of subsidence
Time Frame
3 months post-op
Title
Rate of fusion
Time Frame
6 months post-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce E. Mathern, M.D.
Organizational Affiliation
VCU Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
VCU Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0631
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25360528
Citation
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.
Results Reference
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Safety Study of Preservon-Treated Bone Implants for Cervical Fusion in the Treatment of Cervical Radiculopathy or Myelopathy

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