Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

Performance of the Hedrocel(R) Cervical Fusion Device

Lead Sponsor:

Zimmer Biomet

Conditions:

Symptomatic Cervical Disc Disease

Eligibility:

All Genders

18-70 years

Phase:

PHASE3

Brief Summary

The objective of this clinical investigation is to compare patients treated with Anterior Cervical Discectomy and Fusion (ACDF) using the Hedrocel Cervical Fusion Device, with a concurrent, randomized...

Detailed Description

The objective of this clinical investigation is to compare patients treated with Anterior Cervical Discectomy and Fusion (ACDF) using the Hedrocel Cervical Fusion Device, with a concurrent, randomized...

Eligibility Criteria

Inclusion

  • The patient qualifies for ACDF based upon physical examination and medical history. The patient has single or two adjacent levels(s) symptomatic cervical disc disease (including disc herniation and/or spondylosis) from the C3-C4 disc to the C7-T1 disc with associated radiculopathy and/or myelopathy due to nerve root and/or spinal cord compression due to herniated nucleus pulposus or osteophyte formation on the posterior vertebral endplates. Patients who are candidates for surgery based on radicular symptoms must have at least one month of conservative treatment prior to inclusion in the study.
  • The patient has no history of previous anterior cervical fusion surgery at the involved levels.
  • The patient has no history of previous cervical fusion surgery at the adjacent levels.
  • The patient is willing and able to provide written informed consent.
  • The patient is likely to complete the required follow-up.

Exclusion

  • The patient is mentally compromised (e.g., under treatment for a psychiatric disorder or has senile dementia or Alzheimer's disease), or has evidence of alcohol or other substance abuse for the previous 12 months.
  • The patient has a neuromuscular disorder that would engender unacceptable risk of instability, implant fixation failure, or complications in postoperative care.
  • The patient has a diagnosed systemic disease that requires the chronic administration of nonsteroidal anti-inflammatory and steroidal drugs.
  • The patient has osteopenia to a degree that would contraindicate spinal instrumentation (borderline osteoporosis).
  • The patient has osteoporosis to a degree that would contraindicate spinal instrumentation.
  • The patient is unable or unwilling to attend postoperative follow-up visits.
  • The patient has received an investigational drug within the previous six months or an investigational device within the previous 12 months.
  • The patient has a spinal condition other than Cervical DDD based upon physical examination and medical history.
  • The patient has an infection site distant from the involved levels that may spread to the involved levels hematogenously.
  • The patient has insufficient bone stock to fix the component.
  • The patient has a known sensitivity to metallic implants.
  • The patient is a prisoner.
  • The patient has a Body Mass Index (BMI) greater than or equal to 40.

Key Trial Info

Start Date :

December 1 2001

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2009

Estimated Enrollment :

231 Patients enrolled

Trial Details

Trial ID

NCT00758758

Start Date

December 1 2001

End Date

June 1 2009

Last Update

August 23 2013

Active Locations (13)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 4 (13 locations)

1

Cedars-Sinai Medical Center Institute for Spinal Disorders

Los Angeles, California, United States, 90048

2

Orthopaedic Specialties

Clearwater, Florida, United States, 33756

3

Southeastern Clinic Research

Orlando, Florida, United States, 32804

4

Fort Wayne Orthopedics

Fort Wayne, Indiana, United States, 46804