Performance of the Hedrocel(R) Cervical Fusion Device

Symptomatic Cervical Disc Disease Clinical Trial

Official title:

Performance of the Hedrocel(R) Cervical Fusion Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00758758
• Other study ID #: IC 003-99
• Status: Completed
• Phase: Phase 3
• First received: September 23, 2008
• Last updated: August 9, 2013
• Start date: December 2001
• Est. completion date: June 2009

Study information

• Verified date: August 2013
• Source: Zimmer, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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, control group receiving autologous iliac crest bone graft or allograft and test the hypothesis that ACDF with Hedrocel is non-inferior to ACDF with allograft or autologous bone graft.

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, control group receiving autologous iliac crest bone graft. Success criteria include radiographic evidence of fusion, and improvement in pain, function and overall quality of life. If shown to be successful, the use of the Hedrocel Cervical Fusion Device would eliminate complications associated with harvesting autologous bone graft and provide an alternative for those who are unable to provide autologous bone graft from the iliac crest.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: June 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Symptomatic Cervical Disc Disease

Intervention

Device:
• Anterior Cervical Discectomy and Fusion
Implantation of Hedrocel
• Anterior Cervical Discectomy and Fusion
Implantation of Allograft
• Anterior Cervical Discectomy and Fusion
Implantation of Autograft

Locations

Country	Name	City	State
United States	Four East Madison Orthopaedic Associates, PA	Baltimore	Maryland
United States	Boston Spine Group, LLC	Boston	Massachusetts
United States	Orthocarolina	Charlotte	North Carolina
United States	University of Virginia Health System - Department of Neurosurgery	Charlottesville	Virginia
United States	Orthopaedic Specialties	Clearwater	Florida
United States	Inova Fairfax Hospital	Fairfax	Virginia
United States	Fort Wayne Orthopedics	Fort Wayne	Indiana
United States	Cedars-Sinai Medical Center Institute for Spinal Disorders	Los Angeles	California
United States	Spine Surgery PSC	Louisville	Kentucky
United States	Twin Cities Spine Center	Minneapolis	Minnesota
United States	Howell Allen Clinic	Nashville	Tennessee
United States	Vanderbilt Orthopedic Institute	Nashville	Tennessee
United States	Southeastern Clinic Research	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Clinical Success (NDI, Fusion, Additional Surgical Procedures)	Success was defined as an improvement in patient functional capability using the Neck Disability Index (NDI) by at least 10% as compared to the pre-operative evaluation and Radiographic evidence of fusion (< 3mm translation; < 5° angular motion and absence of radiolucent lines around = 50% of the device)and A comparison of the incidence of intraoperative and postoperative complications which resulted in additional surgical procedures of revision, removal or supplemental fixation at 12 months	12 Months	Yes
Primary	Neck Disability Index (NDI)	The Neck Disability Index (NDI) is an instrument used for testing self-rated disability in neck pain patients. The Neck Disability Index (NDI) consists of 10 questions, each with a score up to 5, for a total score of 50. The lower the score, the less self-rated disability.; NDI scoring: 0 - 4 = No disability; 5 - 14 = Mild disability; 15 - 24 = Moderate disability; 25 - 34 = Severe disability; 35 or over = Complete disability	12 Months	No