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