ANN’S STORY BONE GRAFTING (Spine and Orthopaedic)

SPINAL FUSION SURGERY HELPS ANN’S CHRONIC BACK PAIN

Ann thought spine surgery was the very last option for her severe back pain, so she tried to work through the discomfort. It wasn’t until after surgery with Infuse™ Bone Graft that she realized just how much the pain had been affecting her life.

Ann admits she didn't fully realize how bad she was feeling until the pain was gone. "Before surgery, I'd lost 15 pounds because I wasn't eating or sleeping enough," she says. "Since then, I've gained back the weight I'd lost, and people say they can tell I feel good. I no longer have that 'chronic pain grimace' anymore. And I can move normally. Before that, I just kind of hobbled around, holding my back."

LIFE WITH BACK PAIN

As a primary care sports medicine specialist, Ann built a successful career by helping college athletes stay off the injured roster and on the playing field. If a Division I player under her care came in complaining of severe back pain, she'd quickly pinpoint the problem and prescribe the proper treatment, even if it meant sidelining a star player.

But when Ann — a dedicated athlete in her own right, with 25 marathons under her belt — found herself at the mercy of severe back pain, she knew her spine was the culprit. But she continued to work and run through her discomfort because, as she says, "Back pain had always been a part of my life."

Ann continued to dismiss the persistent ache in her lower back until it started to interfere with her running ability. "Eventually, the pain started getting worse when I ran downhill," she says. "I still pretty much ignored it. Then my leg started going numb and I developed a motor problem called 'foot drop.' That’s when I finally decided to get it checked out."

DIAGNOSIS AND TREATMENT OPTIONS

Ann found she had spondylolisthesis, a condition — congenital, in her case — where one vertebra slips over the other. She also was diagnosed with degenerative disc disease, spinal stenosis, and foraminal stenosis, all of which may result in back pain, leg numbness, and loss of mobility.

For several years, Ann chose to work with a physical therapist instead of opting for surgery. "Anything to avoid spine surgery,” Ann said, “I'd always heard you didn't want to have spine surgery until you’d run your chassis to the ground and exhausted all your other options."

Eventually, her symptoms became so debilitating that it became difficult for her to do her job or maintain any semblance of a normal training schedule. A "friendly intervention" by some concerned running buddies also helped Ann reconsider her stance against spine surgery.

SPINE SURGERY WITH INFUSE BONE GRAFT

Ann's first step was to find a spine surgeon she could be confident in and comfortable with. "You want someone who can identify the right operation for the right person, and at the right time," she said. “And they also have to have technical expertise."

Her search ended with Dr. Kevin Foley with the Semmes-Murphy Clinic in Memphis, TN, who recommended a lumbar spinal fusion. Spinal fusion involves removing the degenerated disc material and fusing, or joining together, the vertebrae on either side of the disc space. This requires a bone graft, or small piece of bone material, to help promote bone growth at the fusion site.

Traditionally, surgeons obtain this graft material either from a donor (allograft) or from the patient's hip (autograft), which requires an additional surgical procedure. Ann’s surgeon, however, performed the procedure using Infuse Bone Graft with a lumbar cage. The active ingredient in Infuse Bone Graft is recombinant human bone morphogenetic protein-2 (rhBMP-2), which stimulates bone formation. By using Infuse Bone Graft, Dr. Foley was able to achieve the goals of spinal fusion, but without the additional bone harvest procedure.

Following her surgery, Ann slept through the night as her anesthesia wore off. "The next morning, I woke up almost without any pain at all," she said. "Maybe some operative pain, but not that deep, deep pain in my lower back that I had before." Ann was able to leave the hospital three days after surgery, and was able to manage her post-op discomfort with regular-strength pain relievers. Within a week, she was able to return home.

Dr. Foley was able to check the progress of her healing with CT scan films Ann shipped to him each month. At four months, he cleared her for light running. "Now, I’m up to running 30–40 miles a week, as well as cycling and weight training, and I'm back on my ab-strengthening program."

LIFE AFTER SURGERY

Ann says her only problem now is bearing in mind that her back is "better—not bionic. Once you have a spinal fusion, you need to be mindful that the areas above and below the fusion may be more vulnerable," she explains. "So I do have to rein myself in and be more careful than perhaps I would have in the past.

"But I'm very glad I had the surgery. I feel fine, and I’m back to doing the things I love."

▪In an experimental rabbit study, rhBMP-2 has been shown to elicit antibodies that are capable of crossing the placenta. Reduced ossification of the frontal and parietal bones of the skull was noted infrequently (<3%) in fetuses of rabbit dams immunized to rhBMP-2; however, there was no effect noted in limb bud development. There are no adequate and well-controlled studies in human pregnant women. Women of child bearing potential should be warned by their surgeon of potential risk to a fetus and informed of other possible orthopedic treatments.
▪Women of childbearing potential should be advised that antibody formation to rhBMP-2 or its influence on fetal development has not been completely assessed. In the clinical trial supporting the safety and effectiveness of the Infuse™ Bone Graft/LT-Cage™ Lumbar Tapered Fusion Device, 2/277 (0.7%) patients treated with Infuse™ Bone Graft component and 1/127 (0.8%) patients treated with autograft bone developed antibodies to rhBMP-2. The effect of maternal antibodies to rhBMP-2, as might be present for several months following device implantation, on the unborn fetus is unknown. Additionally, it is unknown whether fetal expression of BMP-2 could re-expose mothers who were previously antibody positive. Theoretically, re-exposure may elicit a more powerful immune response to BMP-2 with possible adverse consequences for the fetus. However, pregnancy did not lead to an increase in antibodies in the rabbit study. Studies in genetically altered mice indicate that BMP-2 is critical to fetal development and that a lack of BMP-2 activity may cause neonatal death or birth defects. It is not known if anti-BMP-2 antibodies may affect fetal development or the extent to which these antibodies may reduce BMP-2 activity.
▪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 the Infuse™ Bone Graft/Medtronic Interbody Fusion Device.
▪The safety and effectiveness of the Infuse™ Bone Graft/Medtronic Interbody Fusion Device in nursing mothers has not been established. It is not known if BMP-2 is excreted in human milk.

SPINAL INDICATIONS

BRIEF SUMMARY OF INDICATIONS, CONTRAINDICATIONS, AND WARNINGS FOR:
Infuse™ Bone Graft/LT-Cage™ Lumbar Tapered Fusion Device
Infuse™ Bone Graft/Inter Fix™ Threaded Fusion Device
Infuse™ Bone Graft/Inter Fix™ RP Threaded Fusion Device
Infuse™ Bone Graft/Perimeter™ Interbody Fusion Device
Infuse™ Bone Graft/Clydesdale™ Spinal System
Infuse™ Bone Graft/Divergence-L™ Anterior/Oblique Lumbar Fusion System
Infuse™ Bone Graft/Pivox™ Oblique Lateral Spinal System

The Infuse™ Bone Graft/Medtronic Interbody Fusion Device is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1, who may also have up to Grade I spondylolisthesis or Grade 1 retrolisthesis at the involved level.

The following interbody devices and surgical approaches may be used with Infuse™ Bone Graft:

The LT-Cage™ Lumbar Tapered Fusion Device, implanted via an anterior open or an anterior laparoscopic approach at a single level.
The Inter Fix™ or Inter Fix™ RP Threaded Fusion Device, implanted via an anterior open approach at a single level.
The Perimeter™ Interbody Fusion Device implanted via a retroperitoneal anterior lumbar interbody fusion (ALIF) at a single level from L2-S1 or an oblique lateral interbody fusion (OLIF) approach at a single level from L5-S1.
The Clydesdale™ Spinal System, implanted via an OLIF approach at a single level from L2-L5.
The Divergence-L™ Anterior/Oblique Lumbar Fusion System interbody device implanted via an ALIF approach at a single level from L2-S1 or an OLIF approach at a single level from L5-S1.
The Pivox™ Oblique Lateral Spinal System implanted via an OLIF approach at a single-level from L2-L5.

The Infuse™ Bone Graft/Medtronic Interbody Fusion Device consists of two components containing three parts – a spinal fusion cage, a recombinant human bone morphogenetic protein, and a carrier/scaffold for the bone morphogenetic protein and resulting bone. These components must be used as a system for the prescribed indication described above. The bone morphogenetic protein solution component must not be used without the carrier/scaffold component or with a carrier/scaffold component different from the one described in this document. The Infuse™ Bone Graft component must not be used without the Medtronic Interbody Fusion Device component.

NOTE: The Inter Fix™ Threaded Fusion Device and the Inter Fix™ RP Threaded Fusion Device may be used together to treat a spinal level. The LT-Cage™ Lumbar Tapered Fusion Device, the Perimeter™ Interbody Fusion Device, the Clydesdale™ Spinal System, the Divergence-L™ Anterior/Oblique Lumbar Fusion System, and the Pivox™ Oblique Lateral Spinal System implants are not to be used in conjunction with either the Inter Fix™ OR Inter Fix™ RP implants to treat a spinal level.

The Infuse™ Bone Graft/Medtronic Interbody Fusion Device is contraindicated for patients with a known hypersensitivity to recombinant human Bone Morphogenetic Protein-2, bovine Type I collagen, or to other components of the formulation and should not be used in the vicinity of a resected or extant tumor, in patients with any active malignancy, or patients undergoing treatment for a malignancy; in patients who are skeletally immature; in pregnant women; or in patients with an active infection at the operative site or with an allergy to titanium, titanium alloy, or polyetheretherketone (PEEK).

There are no adequate and well-controlled studies in human pregnant women. In an experimental rabbit study, rhBMP-2 has been shown to elicit antibodies that are capable of crossing the placenta. Women of child bearing potential should be warned by their surgeon of potential risk to a fetus and informed of other possible orthopedic treatments. The safety and effectiveness of this device has not been established in nursing mothers. Women of child- bearing potential should be advised to not become pregnant for one year following treatment with this device.

Please see the Infuse™ Bone Graft package insert for the complete list of indications, warnings, precautions, adverse events, clinical results, definition of DDD, and other important medical information. The package insert also matches the sizes of those sized devices that are indicated for use with the appropriate Infuse™ Bone Graft kit. An electronic version of the package insert may be found at www.medtronic.com/manuals.

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician with appropriate training or experience.

TIBIA TRAUMA INDICATIONS

BRIEF SUMMARY OF INDICATIONS, CONTRAINDICATIONS, AND WARNINGS FOR:
INFUSE™ BONE GRAFT

Infuse Bone Graft is indicated for treating acute, open tibial shaft fractures that have been stabilized with IM nail fixation after appropriate wound management. Infuse Bone Graft must be applied within 14 days after the initial fracture. Prospective patients should be skeletally mature.

Infuse Bone Graft consists of two components – recombinant human Bone Morphogenetic Protein-2 solution and a carrier/scaffold for the bone morphogenetic protein solution and resulting bone. These components must be used as a system. The bone morphogenetic protein solution component must not be used without the carrier/scaffold component or with a carrier/scaffold component different from the one described in this document.

Infuse Bone Graft is contraindicated for patients with a known hypersensitivity to recombinant human Bone Morphogenetic Protein-2, bovine Type I collagen or to other components of the formulation and should not be used in the vicinity of a resected or extant tumor, in patients with an active malignancy or patients undergoing treatment for a malignancy. Infuse Bone Graft should also not be used in patients who are skeletally immature, in patients with an inadequate neurovascular status, in patients with compartment syndrome of the affected limb, in pregnant women, or in patients with an active infection at the operative site.

There are no adequate and well controlled studies in human pregnant women. In an experimental rabbit study, rhBMP-2 has been shown to elicit antibodies that are capable of crossing the placenta. Women of child bearing potential should be warned by their surgeon of potential risk to a fetus and informed of other possible orthopedic treatments. The safety and effectiveness of this device has not been established in nursing mothers. Women of child-bearing potential should be advised to not become pregnant for one year following treatment with this device.

Please see the package insert for the complete list of indications, warnings, precautions, adverse events, clinical results, and other important medical information.