Spinal fusion surgery: The science behind Manning's life changing operation

By Christi Sodano | Feb 02, 2012 | Medill Reports Chicago

With his home turf the epicenter of the Super Bowl buzz this season, his younger brother in contention for the NFL championship and a potentially life-changing contract decision only one month away, it is little wonder why Peyton Manning’s recovery is at the forefront of Indianapolis conversation.

Last September, Manning underwent his third neck surgery in two years. The controversial spinal-fusion surgery aimed to correct a cervical disc herniation in his neck has been associated with declines in his on-field performance.

Cervical disc herniation occurs when the cushioned discs, which act as shock absorbers between the vertebrae, bulge and pinch the spinal cord or nerve root that are encased in the spine.

This is generally caused by repeated neck motion or trauma and can result in loss of motor function and numbness or sharp pain, said Dr. Selene Parekh, associate professor of orthopedic surgery at Duke University.

Typically surgery is considered only after the patient has endured prolonged pain of up to six weeks, said Dr. Wellington Hsu, assistant professor of orthopedic surgery at the Feinberg School of Medicine at Northwestern University.

In Manning’s case, disc fragments pinching the nerve root in his cervical spine likely caused acute pain and decreased arm strength.

During the September operation, doctors removed a single disc through a small incision in the front of the neck, alleviating pressure on the nerve root and replacing the disc with bone grafts or a plastic implant. Once the new disc is set into place, the surrounding vertebrae are fused using a titanium plate and screws in the upper and lower vertebrae.

Prior to Manning’s spinal-fusion surgery, he underwent two microdiscectomies in an attempt to correct the problem. After a series of diagnostic tests in September showed his recovery was not on track, spinal-fusion surgery became the next step.

Although the surgery is touted by many industry professionals as more than 95 percent successful, Dr. Kenneth Pettine, an American Academy of Orthopedic Surgeons member, said in a 2010 report, “The perception is that this is a great operation. I’m not saying it’s an awful operation. We’re just presenting the data that it’s certainly not 95 percent.”

“When you get one level fused, the next level up and down has to take all the motion. This very often accelerates into adjacent level dysfunction. That can happen two years later, that can happen 10 years later,” said Shaeffer Bannigan, development engineer at NuVasive, Inc., a spinal surgery technology company.

Hsu, who published a study in 2010 about the likelihood of athletes to return to the NFL after spinal- fusion surgery said, “For a player like Manning, the time frame to play football is closing in and when his arm strength was not improving fast enough, he elected to have the fusion.”

In his study, Hsu analyzed 99 players, some of whom are still on the field, and found on average players treated surgically had a higher return-to-play rate and longer career than players who are treated nonsurgically and position was a key factor in success after surgery.

Performance after surgery largely depends on the player's position and is particularly relevant for quarterbacks, Parekh said.

“Loss of function, even if only by a few degrees, is significant because if neck rotation is inhibited, that can affect your ability to assess what is happening on the field,” he said.

Recovery plans after surgery vary depending on the patient.

According to Parekh’s medical-information blog, the bone usually takes 12 weeks to fuse and after fusion, “a prolonged course of therapy will be needed to regain some of the loss of function, mobility and strength.”

Despite a lengthy recovery process, Hsu speculated that, “Manning will be able to come back to the NFL next year. What his level of play will be after he returns is still yet to be determined.”

However, Hsu’s opinion is not shared by all.

“My personal opinion was that there wasn’t an entirely honest view of what was happening him, there is a real chance that he may never return to play in the NFL,” Parekh said.

View this article in its original publication.

Now Enrolling: ACADIA Facet Replacement System Study for Lumbar Spinal Stenosis

The ACADIA™ Facet Replacement System (AFRS) study is designed to compare two treatment options for lumbar spinal stenosis and is one of many clinical trials in which The Spine Institute is participating. This page is designed to provide more information as to what the study involves and who is eligible to participate. After learning about the study here, if you are interested in participating or would like to receive more information, please contact our research coordinator, Nic Rittenhouse, at 970.669.8881, ext. 229 or complete our contact form.

Pre-Procedure Evaluation

To be eligible for the ACADIA™ study, you must meet specific study criteria that are designed to find the best possible candidates for the study. During your pre-procedure evaluation, your doctor will review your medical history, perform a neurological exam, and take images of your lower spine called radiographs to determine the extent of your stenosis. You will also be asked to complete several questionnaires to help us determine the level of pain or discomfort your stenosis is causing you and how it’s affecting your quality of life.

The Procedure

If you qualify for the study and choose to participate, your doctor will treat your stenosis with one of two procedures: surgical decompression with facet replacement using the ACADIA™ Facet Replacement System or surgical decompression with spinal fusion, which is a current standard of care for treating lumbar spinal stenosis. The decision as to which treatment you will receive is decided at random. As part of the study, two out of every three patients will receive the ACADIA™ Facet Replacement System and one out of every three patients will receive spinal fusion.

Post-Procedure Follow-Up

After your procedure, you will need to attend follow-up visits at six weeks, three months, six months, twelve months, and twenty-four months so your doctor can document your progress.

Frequently Asked Questions

What is the purpose of a clinical study?

A clinical study (also called a clinical trial or a research trial) is to examine treatment options for specific health conditions.  Although there are many types of clinical trials, all must follow the strict rules set by the U.S. Food and Drug Administration (FDA). These rules help protect the rights and safety of those who volunteer to take part in clinical research studies.

Can I receive the ACADIA™ Facet Replacement System without joining the study?

No, the ACADIA™ Facet Replacement System is currently only available to patients through a clinical study.

Are there any costs involved with taking part in the ACADIA™ Clinical Study?

Any study-related tests, procedures, physician fees, or services that are not covered by your insurance will be provided to you at no cost. However, you will be responsible for your insurance co-pays.

How do I know if I’m right for the ACADIA™ study?

In addition to the medical information that your doctor will collect at your pre-procedure evaluation, there are criteria that will make you right for the study (inclusion criteria), and criteria that will automatically exclude you (exclusion criteria). Here is a brief list – the complete list may be found on the ACADIA™ study protocol summary on The Spine Institute website.

Inclusion criteria include:

• 21-85 years of age and skeletally mature
• Undergone at least six cumulative months of conservative treatment prior to surgery including any of the following:

- Medications
- NSAIDs
- Physical therapy
- Bracing
- Chiropractic manipulation
- Modified activities of daily living
- Epidural injections
- Facet block injections

• Persistent leg, thigh, and/or buttock symptoms, including pain, numbness, burning or tingling
• Willing and able to comply with post-operative and routinely scheduled clinical and radiographic evaluations
• Live in the immediate area of The Spine Institute (Loveland, Colorado) and have no plans to relocate to another geographic area before the completion of the study, or live outside the immediate area and are willing to comply with scheduled postoperative visits with a Spine Institute physician.

Exclusion criteria include:

• Previous surgical procedure at the operative or adjacent level, except for micro-discectomy, laminectomy, lamino/foraminotomy, rhizotomy, IDET, and/or interspinous spacer
• Previous lumbar fusion or disc replacement procedure
• Osteoporosis
• Certain levels of spondylolisthesis or retrolithesis
• Scoliosis of the lumbar spine
• Discogenic back pain because of torn, herniated, inflamed or irritated disc or other cause that give you axial back pain from degenerative disc disease
• Spinal stenosis at more than three lumbar segments
• Acute trauma to the lumbar spine has occurred within the last 24 months
• Type I Diabetes
• Known allergy to cobalt chromium or titanium
• Pending litigation related to back pain or injury, or are currently receive Worker’s Compensation

These criteria will not automatically include you in or exclude you from in the ACADIA™ Clinical Study, they are merely to give you an idea of what’s involved. The complete list is available on the clinicaltrials.gov website.

For further questions on the study or to schedule a pre-procedure evaluation, please contact The Spine Institute Research Coordinator, Nic Rittenhouse, at 970.669.8881 ext. 229 or complete our contact form.

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Are You a Candidate for Lumbar Artificial Disc Replacement?

At the Spine Institute, we advocate for artificial disc replacement over fusion for a number of reasons. While everyone's condition is unique and you must always discuss your options for artificial disc replacement with your physician, here are the criteria for a candidate for a ProDisc-L implant made by Synthes:

• You must be suffering from Degenerative Disc Disease (DDD) at only one level between L3 and S1. DDD is defined as a disc that is worn out or has become injured and is causing pain. This determination is made based on history, physical examination and x-rays
• You should have at least six months of conservative treatment (e.g., medications, physical therapy, etc.) without relief of symptoms
• Your vertebrae must be dimensionally large enough to support the device
• You must not have an active infection, either throughout your body or localized to your spine
• You must have good bone quality (no osteoporosis or osteopenia)
• You must not be allergic to cobalt chromium, molybdenum, polyethelene, titanium, or tantalum
• You must be old enough that the bones in your body are mature and no longer growing
• You must not have spinal anatomy that would prevent implantation of the device or cause the device to be unstable in your body, as determined by your doctor

Learn more about other devices we use for lumbar artificial disc replacement on our website.

Remember, these are just criteria for the artificial disc replacement device. Only you and your doctor can decide the best treatment for you and your condition.

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10 Tips for a Healthy Back

Here are 10 tips for keeping your back healthy from knowyourback.org:

1. Standing: Keeping one foot forward of the other, with knees slightly bent, takes the pressure off your low back. 
2. Sitting: Sitting with your knees slightly higher than your hips provides good low back support. 
3. Reaching: Stand on a stool to reach things that are above your shoulder level. 
4. Moving Heavy Items:  Pushing is easier on your back than pulling. Use your arms and legs to start the push. If you must lift a heavy item, get someone to help you. 
5. Lifting: Kneel down on one knee with the other foot flat on the floor as near as possible to the item you are lifting. Lift with your legs, not your back, keeping the object close to your body at all times. 
6. Carrying: Two small objects (one in either hand) may be easier to handle than one large one. If you must carry one large object, keep it close to your body. 
7. Sleeping: Sleeping on your back puts 55 lbs. of pressure on your spine. Putting a couple of pillows under your knees cuts the pressure in half. Lying on your side with a pillow between your knees also reduces the pressure. 
8. Control Your Weight:  Additional weight puts a strain on your back. Keep within 10 lbs. of your ideal weight for a healthier back.
9. Quit Smoking:  Smokers are more prone to back pain than nonsmokers because nicotine restricts the flow of blood to the discs that cushion your vertebrae. 
10. Minor Back Pain:  Treat minor back pain with anti-inflammatories and gentle stretching, followed by an ice pack.

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Definitive Back-Pain Study?

written by Biloine W. Young | Orthopedics This Week | Dec. 6, 2011


Can a single injection of stem cells repair and regenerate diseased lumbar discs? That question may soon be answered by the first of its kind nationwide study that will test the safety and efficacy of the use of mesenchymal precursor cells (MPCs) to replace bone, cartilage and muscle.

Headquartered at the University of California, Davis, the study will be directed by Dr. Kee Kim, associate professor and chief of spinal neurosurgery at UC Davis Health System. He will collaborate with Scott Fishman, professor and chief of pain medicine and co-principal investigator, to monitor the patients' progress.

An estimated 30 million people in the United States suffer from back pain. Degenerative disc disease is the most common cause of low-back pain, which develops with the gradual loss of a material called proteoglycan, which cushions the bones of the spine and enables normal motion.

"Many scientists and clinicians have injected all different kinds of material into the degenerated disc, hoping that something good will happen. Thus far, we have not been very successful, but we hope that a stem cell-based therapy will be the answer that we have been seeking for decades," Kim said. In pre-clinical studies on sheep with discs that were damaged or degenerated, a single injection of the stem cells was found to make the discs indistinguishable from healthy ones.

"If safety and efficacy are shown in the study, this would be revolutionary,” Kim noted. “It would imply that we can possibly turn back the clock on aging by not only stopping the progression of degenerative changes in the disc, but also reversing the degenerative process," he said. The researchers plan one single injection of adult stem cells directly into the diseased lumbar discs.

Researchers will enroll approximately 100 study participants, 10 at UC Davis and the rest at 11 other medical centers throughout the country. The participants will be individuals who have suffered from moderate low-back pain for a minimum of six months and whose condition has not responded to other, conventional treatments.

The patients will be divided into four groups. One group will receive a high dose of MPCs plus hyaluronic acid, a substance that facilitates the localization and retention of the stem cells. A second group will receive a lower dose of MPCs, plus the hyaluronic acid. A third group will receive the hyaluronic acid alone and a fourth group will receive only the saline solution.

"As an investigator, the design of this study is one of its most attractive features. This type of randomized study where the patients are blinded to the treatment is as good as it's going to get to eliminate any possible bias," Kim said.

The current study is sponsored by Mesoblast Ltd., of Melbourne, Australia, which is investigating stem cell technology to regenerate and repair bone and cartilage. The MPCs are derived from a single adult donor's bone marrow to ensure homogeneity, thus minimizing the risk of rejection by the recipient. Kim will not receive compensation from Mesoblast for his participation in the study.

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Stem Cell Shots into the Heart Could Stave Off Chest Pain

This story from ABC World News Tonight includes a video that helps demonstrate the healing power of adult stem cells. Instead of injecting a patient's own adult stem cells into the spine to enable healing as we are doing at The Spine Institute, in this story, the adult stem cells are being injected into the patient's heart to treat chest pain.

The video that immediately follows the story of treating a heart with adult stem cells tracks the progress of a young man with a spinal cord injury who was treated with embryonic stem cell therapy. This therapy is different from the work we are doing with adult stem cells, but it's a remarkable testament to the healing power of stem cells.

Go to the story and video

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5 Comments on Spine Surgeries in ASCs From Surgeons Who Perform Them

written by Laura Miller | Becker's Orthopedic, Spine, and Pain Management Review | November 21, 2011

Here are five spine surgeons performing cases in ambulatory surgery centers and why they urge other surgeons to transition into the outpatient setting.

1. Richard Hynes, MD, The Back Center (Melbourne, Fla.). Dr. Hynes says the advantages of performing cases in the ASC include the same or quicker recovery time, reduced length of stay in a medical facility and same-day recovery. He performs several procedures, including laminectomies, anterior cervical discectomies and fusions and other minimally invasive, percutaneous spine procedures in an outpatient ambulatory surgery center.

Improved technology for less invasive procedures has made it possible to bring spine cases into the outpatient setting, according to Dr. Hynes. Interbody fixation, bone morphogenic protein and percutaneous procedures are the way of the future, he says, and the methodology will continue to evolve for better outcomes.

2. James Lynch, MD, SpineNavada, Surgery Center of Reno. Dr. Lynch performs spine surgery in an ASC and says it's good business in today's cost- and quality-conscious healthcare environment to do so. Positive data for spine surgery and spine surgeons in the ASC setting will play a large role in the future, as comparative profiling of physicians using data points allows patients to "shop" for physicians and hospitals to benchmark providers against one another, he says.

He expects to see spine technology revolve around minimally invasive spine surgery, robotics, nuclear disc replacement and imaging in the future. An additional shift toward generic spinal implants could help administrators manage costs at ASCs and specialty spine facilities.

3. Robert Nucci, MD, Citrus Park Surgery Center (Tampa, Fla.). Dr. Nucci performs several cases in outpatient ASCs, including far lateral interbody fusions. To perform single or multi-level FLIFs, Dr. Nucci removes the disc through a small incision, inserts a mesh cage and inflates it with allograft bone. The average OR time for the procedure is 129 minutes, surgeon time is 118 minutes and recovery time is 180 minutes. The average blood loss is 141 cc and there is minimal muscle tissue disruption.

Dr. Nucci also performs cervical disc replacement in ASCs using an artificial disc. The average OR time is 92.4 minutes, surgeon time is 77.5 minutes and recovery is 140.8 minutes. Patients are under anesthesia for approximately two hours and experience average blood loss of 95 cc. He hasn't experienced any complications with that procedure. The reasons he cites for performing these cases in an ASC include:

•    The infection rate is lower than in hospitals
•    There is less overhead cost and increased efficiency in the OR
•    Shorter anesthesia time

4. Joan O'Shea, MD, The Spine Institute of Southern New Jersey. Dr. O'Shea predicts at least 80 of practicing spine and neurosurgeons are capable of performing their cases in the ASC, whether they are currently doing so or not. However, not every surgeon is suited for the switch; she notes that ASC surgeons must perform quick surgeries, be confident in their surgical ability and have a good support team.

For her cases in the ASC, Dr. O'Shea increases patient comfort and decreases the risk of complications by:
•    Taking patients off of medications during the preoperative
•    Using cottonoids to stop epidural bleeding
•    Using Decadron to relieve patients of post-operative nausea and vomiting
•    Using cervical traction five to 15 pounds
•    Encouraging early ambulation to avoid urinary issues

5. Ken Pettine, MD, The Spine Institute, Loveland (Colo.) Surgery Center. Spine surgeries performed at the hospital are a significant expense and surgeons stand to leave money on the table if they perform procedures there instead of an ASC, Dr. Pettine says. His experience shows outpatient spine surgery can be performed safely and effectively in ASCs; in the 284 outpatient spine cases Dr. Pettine has performed, he reports no complications (although his ASC has a 23-hour convalescence center). He recommends ASCs start slow with less complicated cases, such as decompressions, and then moving to the more complicated procedures.

To recruit spine surgeons, ASC administrators can present data about the safety and efficacy of spine in other ASCs and entice them through shared income. Insurance contracts for spine can be attractive to payors because implant carve-outs bill 10 percent over retail price while hospitals bill significantly higher. Surgery centers can gain an even higher return if they negotiate discounts with device companies.


Read the original article on Becker's Orthopedic, Spine, and Pain Management Review.

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