NCT00485173

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of the investigational implant (INFUSE® Bone Graft/PEEK Interbody Spacer/Anterior Cervical Plate) as a method of facilitating spinal fusion at a single level from C3-C7 in patients with symptomatic cervical degenerative disc disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
224

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

16 active sites

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

Study Start

First participant enrolled

June 1, 2007

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 12, 2007

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
10 months until next milestone

Results Posted

Study results publicly available

March 19, 2013

Completed
Last Updated

March 19, 2013

Status Verified

December 1, 2012

Enrollment Period

4.5 years

First QC Date

June 8, 2007

Results QC Date

December 14, 2012

Last Update Submit

February 14, 2013

Conditions

Degenerative Disc Disease

Outcome Measures

Primary Outcomes (1)

  • Rate of Overall Success

    Rate of overall success is reported as the percentage of participants who met all of the following criteria: 1. fusion at the treated level; 2. pain/disability (Neck Disability Index) success; 3. neurological status success; 4. no serious adverse event classified as "implant associated" or "implant/surgical procedure associated;" 5. no additional surgical procedure classified as a "failure."

    24 months post-operation

Secondary Outcomes (11)

  • Success Rate of Fusion

    24 months post-operation

  • Success Rate of Neck Disability Index

    24 months post-operation

  • Success Rate of Neurological Status

    24 months post-operation

  • Neck Pain Success Rate

    24 months post-operation

  • Arm Pain Success Rate

    24 months post-operation

  • +6 more secondary outcomes

Other Outcomes (6)

  • Neck Disability Index Score

    24 months post-operation

  • Neck Pain Score

    24 months post-operation

  • Arm Pain Score

    24 months post-operation

  • +3 more other outcomes

Study Arms (1)

INFUSE® Bone Graft

EXPERIMENTAL

In this arm, patients will receive implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.

Device: INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate

Interventions

INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical PlateDEVICE

All patients enrolled in this study will receive the investigational device.

Also known as: ACDF, Anterior Cervical Plate
INFUSE® Bone Graft

Eligibility Criteria

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

You may qualify if:

  • Single-level cervical degenerative disc disease (from C3-C7) requiring surgical treatment and involving intractable radiculopathy and/or myelopathy.
  • Herniated disc and/or osteophyte formation at the level to be treated that is producing symptomatic nerve root and/or spinal cord compression.
  • Unresponsive to non-operative treatment for six weeks or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management.
  • At least 18 years of age and skeletally mature at the time of surgery.
  • A preoperative Neck Disability Index (NDI) score ≥30.
  • A preoperative neck pain score (pain intensity + pain frequency) ≥8 (out of 20) based on the preoperative Neck and Arm Pain Questionnaire.
  • If a female of childbearing potential, patient is not pregnant or nursing and agrees not to become pregnant for one year following surgery.
  • Is willing and able to comply with the study plan and able to understand and sign the Patient Informed Consent Form.

You may not qualify if:

  • A cervical spinal condition other than symptomatic cervical degenerative disc disease requiring surgical treatment at the involved level.
  • Documented or diagnosed cervical instability at the target level, defined by dynamic (flexion/extension) radiographs.
  • Previous surgical intervention at the involved level.
  • Any subsequent planned/staged surgical procedure at the involved or adjacent level(s).
  • Fused level adjacent to the level to be treated.
  • Severe pathology of the facet joints of the involved vertebral bodies.
  • Has osteoporosis, osteopenia, or osteomalacia as determined by DEXA scan.
  • Presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin).
  • Overt or active bacterial infection, either local or systemic.
  • Insulin dependent diabetes.
  • Chronic or acute renal failure or prior history of renal disease.
  • Documented allergy or intolerance to stainless steel, titanium, titanium alloy, polyetheretherketone (PEEK), or tantalum.
  • Is mentally incompetent. (if questionable, obtain psychiatric consult.)
  • Is a prisoner.
  • Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse.
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

S & B Surgery Center

Beverly Hills, California, 90210, United States

Location

Orange County Neurological Association

Laguna Hills, California, 92653, United States

Location

Crane Creek Medical Ctr. The Back Center /Osler Medical

Melbourne, Florida, 32901, United States

Location

The Hughston Clinic, P.C.

Columbus, Georgia, 31908, United States

Location

University of Kansas Medcal Center

Kansas City, Kansas, 66160, United States

Location

Spine Institute

Shreveport, Louisiana, 71103, United States

Location

Springfield Neurological Institute

Springfield, Missouri, 65804, United States

Location

Buffalo Neurosurgery Group

West Seneca, New York, 14224, United States

Location

University of Cincinnati Dept of Neurosurgery

Cincinnati, Ohio, 45219, United States

Location

TriState Orthopedic Treatment Center

Norwood, Ohio, 45212, United States

Location

The Washington Hospital

Washington, Pennsylvania, 15301, United States

Location

Center for Sports Medcine & Orthopedics

Chattanooga, Tennessee, 37404, United States

Location

Semmes Murphey Neurologic & Spine Institute

Memphis, Tennessee, 38120, United States

Location

Central Texas Spine

Austin, Texas, 78731, United States

Location

Brain and Spine Center of Texas, L.L.P.

Plano, Texas, 75093, United States

Location

Inland Neurosurgery & Spine Associates, P.S.

Spokane, Washington, 99204, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Results Point of Contact

Title
Clinical Department
Organization
Medtronic Spinal
msbkclinicalresearch@medtronic.com
1800-876-3133

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2007

First Posted

June 12, 2007

Study Start

June 1, 2007

Primary Completion

December 1, 2011

Study Completion

June 1, 2012

Last Updated

March 19, 2013

Results First Posted

March 19, 2013

Record last verified: 2012-12

Locations

US(16)