NCT00344890

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 27, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

April 7, 2015

Status Verified

April 1, 2015

Enrollment Period

5.3 years

First QC Date

June 23, 2006

Last Update Submit

April 3, 2015

Conditions

Cervical RadiculopathyMyelopathy

Keywords

Cervical fusionAnterior Cervical Discectomy and FusionACDF

Outcome Measures

Primary Outcomes (2)

  • Degree of subsidence

    3 months post-op

  • Rate of fusion

    6 months post-op

Study Arms (2)

Preservon

EXPERIMENTAL
Procedure: Anterior Cervical Discectomy and Fusion

Control

ACTIVE COMPARATOR
Procedure: Anterior Cervical Discectomy and Fusion

Interventions

Anterior Cervical Discectomy and FusionPROCEDURE

1,2,3,or 4 level surgery

ControlPreservon

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VCU Medical Center

Richmond, Virginia, 23298-0631, United States

Location

Related 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.SPINE131005.

    PMID: 25360528RESULT

MeSH Terms

Conditions

RadiculopathySpinal Cord DiseasesKlippel-Feil Syndrome

Interventions

Gene Fusion

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesCentral Nervous System DiseasesDysostosesBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Recombination, GeneticGenetic Phenomena

Study Officials

  • Bruce E. Mathern, M.D.

    VCU Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2006

First Posted

June 27, 2006

Study Start

September 1, 2006

Primary Completion

December 1, 2011

Study Completion

December 1, 2012

Last Updated

April 7, 2015

Record last verified: 2015-04

Locations

US(1)