Performance of the Hedrocel(R) Cervical Fusion Device

NCT00758758 | Completed Phase 3 Results

• 1 other identifier: IC 003-99
• Study Type: interventional
• Target: 231
• Locations: 1 country
• Sites: 13

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, 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.

Conditions

Symptomatic Cervical Disc Disease

Keywords

Anterior Cervical Discectomy and Fusion,; Degenerative Disc Disease,; Cervical Spine,; Herniated Disc

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (8)

Experimental Arm 1

EXPERIMENTAL

Hedrocel 1 level - No plate

Device: Anterior Cervical Discectomy and Fusion

Experimental Arm 2

EXPERIMENTAL

Hedrocel 1 level with plate

Device: Anterior Cervical Discectomy and Fusion

Experimental Arm 3

EXPERIMENTAL

Hedrocel 2 levels with plate

Device: Anterior Cervical Discectomy and Fusion

Control Arm 1

ACTIVE COMPARATOR

Autograft alone - Illiac crest

Device: Anterior Cervical Discectomy and Fusion

Control Arm 2

ACTIVE COMPARATOR

Autograft 1 level with plate

Device: Anterior Cervical Discectomy and Fusion

Control Arm 3

ACTIVE COMPARATOR

Allograft 1 level with plate

Device: Anterior Cervical Discectomy and Fusion

Control Arm 4

ACTIVE COMPARATOR

Autograft 2 levels with plate

Device: Anterior Cervical Discectomy and Fusion

Control Arm 5

ACTIVE COMPARATOR

Allograft 2 levels with plate

Device: Anterior Cervical Discectomy and Fusion

Interventions

Anterior Cervical Discectomy and Fusion DEVICE

Implantation of Hedrocel

Experimental Arm 1; Experimental Arm 2; Experimental Arm 3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (13)

Cedars-Sinai Medical Center Institute for Spinal Disorders

Los Angeles, California, 90048, United States

Location

Orthopaedic Specialties

Clearwater, Florida, 33756, United States

Location

Southeastern Clinic Research

Orlando, Florida, 32804, United States

Location

Fort Wayne Orthopedics

Fort Wayne, Indiana, 46804, United States

Location

Spine Surgery PSC

Louisville, Kentucky, 40202, United States

Location

Four East Madison Orthopaedic Associates, PA

Baltimore, Maryland, 21204, United States

Location

Boston Spine Group, LLC

Boston, Massachusetts, 02120, United States

Location

Twin Cities Spine Center

Minneapolis, Minnesota, 55404, United States

Location

Orthocarolina

Charlotte, North Carolina, 28207, United States

Location

Howell Allen Clinic

Nashville, Tennessee, 37203, United States

Location

Vanderbilt Orthopedic Institute

Nashville, Tennessee, 37232-8774, United States

Location

University of Virginia Health System - Department of Neurosurgery

Charlottesville, Virginia, 22908, United States

Location

Inova Fairfax Hospital

Fairfax, Virginia, 22031, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Laura Herdrich, Sr. CRA
• Organization: Zimmer, Inc

laura.herdrich@zimmer.com

952-830-6224

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2008
• First Posted: September 25, 2008
• Study Start: December 1, 2001
• Primary Completion: January 1, 2009
• Study Completion: June 1, 2009
• Last Updated: August 23, 2013
• Results First Posted: August 12, 2013

Record last verified: 2013-08

Locations

US (13)