BAK® Interbody
`Fusion Systems
`The Complete Interbody
`Fusion System for the Spine
`
`
`Fusion Systems
`The Complete Interbody
`Fusion System for the Spine
`
`
`
`BAK® Interbody
`Fusion Systems
`
`This Patient Information Brochure is
`provided to help you make an informed
`decision about your back surgery.
`
`Normal
`
`Nerve Root
`
`Spinal Cord
`
`Vertebra
`
`Intervertebral Disc
`
`Abnormal
`
`Compressed and
`degenerative disc
`
`Entrapped Nerve Root
`
`
`
`This surgical procedure will be using the BAK®
`Interbody Fusion Systems.
`
`Some common causes of back problems are disc
`injury (e.g., herniation) and disc degeneration.
`Disc degeneration affects about 12 million
`people in the U.S., of whom most are with-
`in the ages of 20 to 65. Approximately
`10 percent of patients with degenera-
`tive discs are candidates for some
`type of spinal surgery.
`
`In your lower back there are five
`vertebrae (bones). Between
`each of the vertebra is a disc.
`Discs are the “shock absorb-
`ers” of your spine and act as
`spacers between vertebrae.
`As discs degenerate, they
`lose their water content and
`height, bringing the vertebrae
`closer together. This results
`in a weakening of the shock
`absorption properties of the
`disc and a narrowing of the
`nerve openings between the
`vertebrae which may pinch
`your nerves. This disc degener-
`ation can eventually cause back
`and leg pain or numbness.
`
`The BAK systems are designed
`to stabilize and fuse the
`degenerative disc space(s),
`with the intent of providing a
`better alternative treatment for
`disc disorders.
`
`1
`
`
`
`What Are the BAK Interbody Fusion Systems?
`The BAK Interbody Fusion Systems are an
`innovative technique for spinal fusion, which is
`less invasive than other methods. This procedure uti-
`lizes small, threaded cylinders to restore the degener-
`ated disc space to or near its original height, relieving
`pressure on your nerves. These systems are approved
`for patients with degenerative disc disease (DDD)
`at one or two levels and may be implanted from the
`second lumbar disc (L2) down to the sacrum.
`
`In addition, patients should be skeletally mature
`and should have had six months of non-operative
`treatment. The BAK systems should not be used in
`patients with severe infection.
`
`What Happens During Surgery?
`During surgery, your doctor will remove portions of
`the painful disc and vertebral bones, allowing the
`implants to be inserted into the disc space. A small
`amount of bone may then be taken from your hip and
`packed inside the BAK systems. The BAK systems
`can be implanted from either a front (anterior), back
`(posterior) or laparoscopic surgical approach. If the
`BAK systems are to be implanted through a laparo-
`scopic approach, surgery is limited to the L4-L5 and
`L5-S1 disc levels. However, patients with multiple
`previous abdominal surgeries should not have the
`BAK systems implanted through the laparoscopic
`approach. Your doctor will make the decision on
`surgical approach based upon your condition.
`
`2
`
`
`
`What are Some of the Benefits of the BAK
`Procedure?
`Part of the development process for the BAK
`systems was a tightly regulated clinical study.
`Clinical outcomes of this study have shown reduc-
`tions in pain and increased activity levels. Based
`upon the findings of this clinical study, the BAK
`systems were shown to offer many advantages over
`traditional fusion methods. The following are some
`advantages:
`• The procedure has been found to have a low
`overall complication rate.
`• The amount of blood loss during surgery can
`be much less than other types of spinal fusion.
`• Postoperative pain may be minimized through a
`decrease in the amount of surgical intervention.
`• Operative procedure time and length of stay in the
`hospital can be less than other fusion methods.
`• Return to daily activities can be much quicker.
`
`These findings follow the general trend in medical
`care toward less invasive surgical techniques that
`provide better outcomes for patients.
`
`3
`
`
`
`What Were the Results of the Clinical Study?
`The clinical study was conducted by 42 doctors at 19
`hospitals across the U.S. The study included a total of
`947 patients treated by either an anterior or posterior
`open approach and measured success in different
`areas. The success rates are shown below for overall
`success and for each measure of success. The clinical
`success rates for patients two years after surgery were
`measured in the following areas:
`
`Complications requiring additional surgery:
`
` Anterior
`
`1 Level 2 Level
`
`98%
`80%
` Fusion Rate
`84%
`86%
` Pain Improvement
` Function Maintained 95%
`94%
` or Improved
` Strength Maintained 94%
` or Improved
` Overall Success
`
`94%
`
`81%
`
`59%
`
` Posterior
`1 Level 2 Level
`94%
`71%
`87%
`81%
`92%
`95%
`
`94%
`
`100%
`
`78%
`
`50%
`
`Note that the number of patients used to calculate the
`success rates were slightly different for each of the
`measurements above due to unavailable data.
`
`For a patient to be considered an overall success,
`improvement was required in all four of the major
`measurements (fusion, pain, function and muscle
`strength).
`
`4
`
`
`
`Based on this clinical study of the open procedure,
`the following statements may also be made about
`the BAK systems:
`• The two-year data indicate the likelihood of
`needing additional supplemental fixation
`increases over time in patients who were not fused
`or showed no improvement in pain.
`• For both anterior and posterior approaches,
`patients with one disc space fused had lower
`overall complication rates than patients with two
`disc spaces fused.
`• Patients implanted with a BAK system from the
`posterior approach had higher rates of operative
`complications and early postoperative surgical
`interventions than patients from the anterior
`approach.
`• Patients implanted from the anterior approach
`had a higher overall rate of early postoperative
`complications than patients implanted from the
`posterior approach.
`
`BAK® Vista® Interbody Fusion Systems
`
`5
`
`
`
`A separate clinical study was conducted that
`evaluated the short-term safety of the BAK systems
`implanted through a laparoscopic surgical approach.
`Based on this clinical study, the following statements
`may be made:
`• Laparoscopic patients had a longer surgical time,
`but shorter hospital stay and lower blood loss,
`compared to open procedure patients. Clinical
`outcomes were similar between the laparoscopic
`patients and open procedure patients with the
`following exceptions: there was a higher incidence
`of ileus (slow movement of the intestines),
`retrograde ejaculation into the bladder,
`postoperative disc herniation, and reoperations
`in the laparoscopic study group.
`• Ten percent of the laparoscopic patients were
`converted to an open procedure resulting in
`longer surgical time and greater blood loss.
`
`BAK® Interbody Fusion Systems
`
`6
`
`
`
`What Are Some Possible Complications of the
`BAK Procedure?
`Spinal surgery is not without risk. It is normal to have
`concerns about possible complications. Complica-
`tions related to spinal implant surgery include, but
`are not limited to, the following: tear in the outer
`lining of the spinal cord (dura); spinal fluid leak;
`nerve complications; infection; slow movement of
`the intestines (ileus); implant migration; blood vessel
`damage/bleeding; leg pain; hematoma; pneumonia;
`retrograde ejaculation into bladder; fractured sacrum;
`blood clots; wound closure problems; and bladder
`problems.
`
`Specific information on the rates of complications
`for the BAK systems and spinal surgery should be
`discussed with your doctor. Please talk with your
`doctor about the results from the research study and
`the possibility that you might need more than one
`operation.
`
`General Surgical Complications Not Specifically
`Related to the Implant May Include:
`•
`reactions to anesthesia
`• attack
`•
`infection
`• bruise (hematoma)
`• blood vessel damage/bleeding
`• pneumonia
`• blood clots
`• wound closure problems
`• death
`
`Please consult your doctor about the complication
`rates related to treatment with the BAK systems.
`
`7
`
`
`
`What Should I Do Before Surgery?
`It is well known that smokers experience lower
`surgical success rates than non-smokers. If you
`smoke, please consider terminating your habit as far
`in advance of the surgical procedure as possible to
`increase your chances of a successful outcome. In
`addition, poor nutrition impacts a body’s ability to
`heal itself. If you eat well-balanced, nutritional
`meals as far in advance of surgery as possible, this
`will also help to increase your chances of a
`successful outcome.
`
`What Should I Expect After Surgery?
`After the surgery is completed, your pain and activity
`level will continue to be evaluated. You will be ex-
`pected to see your doctor several times after surgery
`to evaluate your pain and function. Your doctor may
`take X-rays to check the fusion of your spine. Ask your
`doctor about the postoperative rehabilitation program
`and required follow-up. It is important to follow your
`doctor’s directions carefully in order to recover from
`surgery as quickly as possible.
`
`NOTE: Please call your doctor if you experience
`any of the following symptoms:
`• Signs of infection (i.e. fever, chills, redness around
`incision, increased pain, the feeling of pressure
`in the spine)
`• Bleeding or excessive drainage from your incision(s)
`• Sudden onset of severe pain, or significant increase
`in your pain level
`Loss of sensation, or significantly decreased sensation
`in your legs/feet
`Increased or persistent shortness of breath
`
`•
`
`•
`
`8
`
`
`
`Who Do I Talk To if I Still Have Questions?
`This brochure is provided to give you information
`about your treatment options, but it is not intended
`to replace professional medical care or provide medi-
`cal advice. If you have any further questions or need
`additional information about the BAK systems, please
`call or see your doctor, who is the only one qualified
`to diagnose and treat your condition.
`
`What Patients Should Not Be Implanted
`with the BAK systems?
`The BAK system should not be implanted in patients
`that have infection at the site of operation. The BAK
`system also should not be implanted laparoscopically
`in patients that have had previous multiple
`abdominal surgeries.
`
`In addition, safety and effectiveness have not been
`established in patients with the following conditions:
`gross obesity, three or more levels to be fused, symp-
`tomatic cardiac disease, pregnancy, previous fusion
`attempts at the involved level(s), a severe slipped
`vertebrae, systemic or terminal illness, fragile or soft
`bones or a loss of bone density, a condition requiring
`steroid use or active drug abuse.
`
`9
`
`
`
`©2005 Zimmer Spine, Inc. L1036 Rev. H 10/05
`
`Zimmer Spine, Inc.
`7375 Bush Lake Road
`Minneapolis, MN 55439-2027
`U.S.A.
`
`Telephone 952.832.5600
`or 800.655.2614
`Fax 952.832.5620
`www.zimmerspine.com
`
`
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