INFUSE® Bone Graft/PEEK Interbody Spacer/Anterior Cervical Plate Clinical Trial Underway

For Patients with Degenerative Disc Disease in the Cervical Spine

Spinal surgeons around the country are now enrolling candidates for a clinical trial to study the safety and effectiveness of INFUSE® Bone Graft in the cervical spine. Together with an interbody spacer and anterior cervical plate, INFUSE® Bone Graft is being used as a means to help initiate fusion in the cervical spine (neck) to treat degenerative disc disease (DDD).

This is a non-randomized clinical trial comparing INFUSE® Bone Graft, inside a PEEK Interbody Spacer with an anterior cervical plate, to two previously completed clinical trials. Both control arms previously completed used an allograft (donated human bone) spacer and anterior cervical plate. Patients enrolled in the study will receive the investigational treatment and must be evaluated by their surgeon at regular intervals for at least twenty-four months following the surgery.

Facts About Neck Pain

• Over 66% of Americans will experience neck pain at some time in their life.
  --Spine Journal
• Over 33% of patients with neck pain develop persistent or recurrent symptoms that last longer than 6 months.
  --PAIN Journal, publication of International Association for the Study of Pain
• 25% to 30% of the U.S. population report activity limitations secondary to cervical spinal conditions.
  --American Association of Orthopedic Surgeons

Causes of Pain

The most common cause of pain results from degenerative conditions of the spine, which occur naturally with age. Degenerative changes can cause spinal structures to harden, thicken, dehydrate, expand, and lose elasticity. These changes reduce flexibility and functionality, and the spine becomes less able to tolerate loads and is more susceptible to injury.

The first changes from degeneration generally start in a person's early 20s and continue progressively throughout life. Degeneration and the effects of everyday "wear and tear" can lead to changes in the structural integrity of the discs, joints and vertebral cartilage. While this process cannot be stopped, degenerative effects can be slowed by regular exercise, proper lifting techniques, balanced nutrition, and not smoking.

About Anterior Cervical Discectomy and Fusion (ACDF)

The anterior cervical discectomy and fusion (ACDF) is the most common form of surgery for treating cervical degenerative disc disease. Over 200,000 ACDF procedures are performed annually in the U.S., says the American Association of Neurological Surgeons.

The ACDF procedures in this study are performed through an anterior (front) incision in the neck. The surgeon removes the intervertebral disc and replaces it with a PEEK Interbody Spacer filled with INFUSE® Bone Graft. Then the two vertebrae are stabilized with an anterior plate to allow for bone growth and solid fusion. The goal of the procedure is to relieve compression on the spinal cord and/or nerve roots.

About INFUSE® Bone Graft

• INFUSE® Bone Graft is a recombinant version of BMP-2, a natural protein found in the human body, and is placed on a collagen sponge, which acts as a scaffold for bone to grow. The protein attracts bone forming cells from surrounding tissue to stimulate new bone formation.
• Over 500,000 patients have been successfully treated since FDA approval in 2002.
• Over 15 FDA-approved clinical trials have been performed using INFUSE® Bone Graft, making it the most studied biologic agent available to surgeons today.

FDA Approved Indications for INFUSE® Bone Graft

• Spine (2002) -- Spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2 -- S1 using LT-CAGE® Lumbar Tapered Fusion Device with an anterior approach.
• Trauma (2004) -- Acute, open tibial shaft fractures that have been stabilized with intramedullary nail fixation. Must be applied within 14 days after initial fracture. Patients should be skeletally mature.
• Oral Maxillofacial (2007) -- Alternative to autogenous bone graft for sinus augmentations, and for localized alveolar ridge augmentations for defects associated with extraction sockets.

INFUSE® Bone Graft should not be used immediately prior to or during pregnancy. Women of childbearing potential should be advised not to become pregnant for one year following treatment with INFUSE® Bone Graft. The safety and effectiveness of INFUSE® Bone Graft in nursing mothers has not been established.

INFUSE® Bone Graft has not been studied in pregnant women and should not be used immediately prior to or during pregnancy. Women of child bearing potential should consult their surgeons regarding treatment with this device.

For important safety information -- Spine, please go to https://www.infusebonegraft.com/infuse_indications.html

For important safety information -- Trauma, please go to https://www.infusebonegraft.com/infuse_indications_trauma.html

For important safety information -- Oral Maxillofacial, please go to https://www.infusebonegraft.com/omf_indications.html

About the PEEK Interbody Spacer

• Polyetheretherketone (PEEK) polymer has been successful in a wide range of medical components such as heart valves, dental implants, surgical screws, spinal implants and other operating room devices for more than 20 years.
• The PEEK Interbody Spacer is cleared by the FDA as a vertebral body replacement from levels T1-L5. This device can be used to replace and restore the height of a vertebral body and is intended to be used with supplemental fixation.

About the Anterior Cervical Plate

• The anterior cervical plates are composed of titanium alloy and are the standard of care in ACDF procedures.
• Anterior cervical plates are indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions.

How Can I Enroll?

To participate in the clinical trial, you must meet the following minimum criteria:

• Have cervical degenerative disc disease at a single-level from C3-C7;
• Be at least 18 years of age;
• Undergo at least 6 weeks of non-operative treatment prior to enrollment;
• Not be pregnant or planning a pregnancy during the study;
• Be willing and able to participate in the study for at least the 24-month follow up period.

All potential candidates are subject to the above clinical trial criteria and additional criteria not listed here. Patients enrolled in the study must be evaluated by their surgeon at regular intervals for at least 24 months following surgery.

Caution: Investigational Device.
Limited by Federal (or United States) law to investigational use.