A minimally invasive L5-S1 spinal fusion procedure that stabilizes the foundation of your spine.
Small Incision Size
AxiaLIF+ utilizes a 2-3cm incision near the tailbone, minimizing damage to muscles and tissues around the spine.(1)
When compared to similar L5-S1 spinal fusion procedures, AxiaLIF+ frequently shortened recovery times for patients.(2,3,4,5)
High Fusion Rate
AxiaLIF+ demonstrates a 94% fusion rate for spinal fusion at the L5-S1 joint,(2,3,4) a success rate comparable to alternative methods.
How L5-S1 Spinal Fusion With AxiaLIF+ Works
AxiaLIF+, short for Axial Lumbar Interbody Fusion, is a minimally invasive spinal fusion procedure performed on the lumbar spine at the L5-S1 interspace.
Are you a candidate for L5-S1 spinal fusion? Patients that require stabilization in the spine to stop painful motion and decompress pinched nerves are often candidates for spinal fusion surgery. If you experience these symptoms and present the proper indications, your doctor may recommend a spinal fusion utilizing AxiaLIF+.
Your surgeon will perform the procedure while you are under general anesthesia. Medical professionals will cleanse the lower back area for surgery preparation. Your surgeon will make a small incision (2-3 cm) next to the tailbone, through which the surgeon will insert special instruments guided by surgical imaging techniques. Once a pathway to sacrum and lumbar spine is established through a protected, cannulated tube, your surgeon will extract the diseased disc to clear the space for the AxiaLIF+ implant. When completed, your surgeon will use bone graft to fill the empty disc space.Your surgeon will then insert the AxiaLIF+ implant, a threaded titanium rod, which will stabilize the spine and restore the lost disc height.
You may be a candidate for AxiaLIF+ if you have:
- Degenerative disc disease
- Spondylolisthesis (low grade) at L5-S1
- Spinal stenosis
- Failed fusion from a previous surgery
You may NOT be a candidate for AxiaLIF+ if you have:
Weeks before the surgery
- Presurgical tests
Your medical professionals may perform a blood test, chest X-ray, electrocardiogram, or other tests, to determine if you are fit for surgery. In the doctor’s office, you will sign consent forms and provide your medical history (i.e., allergies, medicines/vitamins, bleeding history, anesthesia reactions, and previous surgeries).
Tell your healthcare provider about any medications (over-the-counter, prescription, herbal, or supplements) that you are taking. Continue taking the medications your surgeon recommends. Stop taking all non-steroidal anti-inflammatory medicines (Naprosyn, Advil, Motrin, Nuprin, Aleve, etc.) and blood thinners (Coumadin, Plavix, etc.) 1 to 2 weeks before surgery as directed by your doctor. Ask your doctor if you are unsure.
- Stop smoking and drinking before surgery
The most important way to achieve a successful spinal fusion is to quit smoking 1 week before and 2 weeks after surgery. Stop cigarettes, cigars, pipes, chewing tobacco, and smokeless tobacco (snuff, dip).
Nicotine prevents bone growth and decreases successful fusion. In one medical study, fusion failed in 40% of smokers compared with 8% of non-smokers (7). Smoking also decreases blood circulation, resulting in slower wound healing and increased risk of infection. Talk with your doctor about help to quit smoking; your doctor may recommend nicotine replacements, pills without nicotine (Wellbutrin, Chantix), or tobacco counseling programs.
Your doctor may recommend you stop drinking alcohol 1 week before and 2 weeks after surgery to avoid bleeding problems.
Day before surgery
- Bowel prep
Emptying the colon is a precaution before a patient undergoes an AxiaLIF+ procedure. An empty bowel is easier to manipulate and protect during surgery and reduces the infection risk in the unlikely case of perforation. The preparation is the same taken to empty the bowel before a colonoscopy.
Of the various bowel preparations, each has slightly different instructions, including tips to make it more tolerable or what to drink with it. Get your preparation early, read the instructions, discuss with your doctor and plan for that day in advance.
The day before surgery, your doctor may recommend that you stop eating solid foods and begin a clear liquid diet. You will take the bowel preparation usually the afternoon/evening before surgery as instructed by your surgeon. Make sure to follow your doctor’s directions as closely as possible.
Morning of surgery
You will arrive at the hospital two hours before (if at a surgery center, typically 1 hour before) your scheduled operation to complete the necessary paperwork and pre-procedure work-ups. An anesthesiologist will talk with you and explain the effects of anesthesia and its risks. Your surgeon and medical staff will place an intravenous (IV) line in your arm.
Your surgeon and his office will likely give you the following instructions:
- No food or drink
- Shower using antibacterial soap. Dress in freshly washed, loose-fitting clothing.
- Wear flat-heeled shoes with closed backs.
- If you have instructions to take regular medication the morning of surgery, do so with small sips of water.
- Remove make-up, hairpins, contacts, body piercings, nail polish, etc.
- Leave all valuables and jewelry at home (including wedding bands).
- Bring a list of medications (prescriptions, over-the-counter, and herbal supplements) with dosages and the times of day usually taken.
- Bring a list of allergies to medication or foods.
This 8-step procedure generally takes 1 to 3 hours.
Step 1: prepare the patient
You’ll lie on your stomach on the operative table and your anesthesiologist will perform anesthesia. Once asleep, your your surgeon and medical staff will cleanse your low back and buttocks area and prepare you for surgery. Because the incision is close to the rectum, the surgeon will sometimes check this region visually by air or contrast via a catheter.
Step 2: make the incision
A 2-3 cm incision is made near the tailbone. The surgeon makes a path between the bowel and sacrum – an area usually filled with fatty tissue. The rectum is carefully avoided as muscles and fat are gently moved aside to open a path to the L5-S1 disc space.
Step 3: locate the damaged disc
Looking at the fluoroscope (a special X-ray), the surgeon carefully passes a long, narrow tube along the path of the sacrum to the sacral base (S1). A drill passed through this tube will then create a passage through the bone to reach the damaged disc.
Step 4: remove the disc
The surgeon uses rotating brushes to remove only the inner nucleus of the disc without disturbing the outer wall (annulus). The loose material is suctioned out leaving a disc space that is cleaned and cleared for fusion. Next, specialized instrumentation will clean out more of the disc space, and the removed disc tissue will be collected to make bone graft to be reused in the procedure. The open disc space will be filled and expanded with bone graft materials.
Step 5: prepare the bone graft
Your collected disc material is mixed with another graft material, typically BMP, into a thick paste. The mortar-like paste is pushed through the tube, filling the empty disc space . This graft contains proteins that help new bone to form and fuse.
Step 6: insert the rod
Guided by x-ray fluoroscopy, the surgeon opens a channel into the L5 bone. Next, the distance across your disc space, from bone to bone, will determine the length of AxiaLIF+ rod needed. Bridged across the disc space, the rod holds the two bones apart to restore normal disc space. The rod is fixed into the bone and more bone graft can be added as needed.
Step 7: insert facet screws (optional)
Depending on the patient’s spinal pathology, facet screws or pedicle screws may help to strengthen stabilization in the spine. If screws are needed, two small incisions are made below the waist over the L5 joint. Screws are inserted using fluoroscopy.
Step 8: close the incision
The tubes and instruments are removed. The skin incision is closed with Steri-Strips or biologic glue.
You will awake in the postoperative recovery area. Blood pressure, heart rate, and respiration will be monitored. Any pain will be addressed. Once awake, you can begin gentle movement (sitting in a chair, aided walking). Most patients will have the opportunity to go home the same day. However, if any difficulty in breathing or unstable blood pressure occurs, the patient may require continued hospitalization.
- After surgery, pain is managed with narcotic medication. Because narcotic pain pills are addictive, they are used for a limited period (2 to 4 weeks). As their regular use can cause constipation, drink lots of water and eat high fiber foods. Laxatives (e.g., Dulcolax, Senokot, Milk of Magnesia) can be bought without a prescription or your surgeon may prescribe one for you. Thereafter, pain is typically managed with acetaminophen (Tylenol).
- If you had a fusion, do not use non-steroidal anti-inflammatory drugs (NSAIDs) (e.g., aspirin; ibuprofen, Advil, Motrin, Nuprin; naproxen sodium, Aleve) for 6 months after surgery. NSAIDs may cause bleeding and interfere with bone healing.
- Do not smoke. Smoking delays healing by increasing the risk of complications (e.g., infection) and inhibits the bones' ability to fuse.
- Do not drive for 2 to 4 weeks after surgery or until discussed with your surgeon.
- Avoid sitting for long periods of time.
- Do not lift anything heavier than 5 pounds (e.g., gallon of milk).
- Housework and yard-work are not permitted until the first follow-up office visit. This includes gardening, mowing, vacuuming, ironing, and loading/unloading the dishwasher, washer, or dryer.
- Postpone any other rigorous activity until your follow-up appointment unless your surgeon specifies otherwise.
- You may need help with daily activities (e.g., dressing, bathing), but most patients are able to care for themselves right away.
- Gradually return to your normal activities. Walking is encouraged; start with a short distance and gradually increase to 1 to 2 miles daily. A physical therapy program may be recommended.
- If applicable, learn how to wear a back brace before leaving the hospital. Wear it when walking or riding in a car.
- You may shower 1 to 4 days after surgery as advised by your surgeon. Follow your surgeon’s specific instructions. No tub bath, hot tub, or swimming pool until your health care provider says it’s safe to do so.
When to Call Your Doctor
- Call if your temperature exceeds 101°F. Call if the incision begins to separate or show signs of infection, such as redness, swelling, pain, or drainage.
Because of the minimally invasive nature of this procedure and its utilization of a small incision, the operation is completed within a short period of time. AxiaLIF+ minimizes blood loss and has very few complications associated with the surgery. The procedure reduces tissue trauma which allows patients to return to daily activities a few weeks after surgery.
Keep in mind that each patient’s recovery differs based on health and lifestyle. Keep a positive attitude and diligently perform your physical therapy exercises.
Recent medical studies have indicated that fusion rates from AxiaLIF+ are 94%(2,3,4). Patients report an average of 63% improvement in back pain for single-level AxiaLIF+ (6,7,8).
This information is not meant to replace any personal consultation that takes place with your doctor.
- What are the risks of this procedure?
- How long will I have to stay in the hospital after surgery?
- How long will it take to return to my daily activities?
- How much pain should I expect after the procedure is performed?
- How long will it take to get back to work?
- Are there medical studies to demonstrate the safety and efficacy of spinal fusion with AxiaLIF+?
As with any surgical procedure, there are risks. With AxiaLIF+, there is minimal dissection of vital nerves, arteries or muscle which decrease the chance of serious complications during surgery. There is a low risk of bowel injury (0.6%)4. Other risks associated with AxiaLIF+ and with L5-S1 spinal fusion, in general, should be discussed with your surgeon.
AxiaLIF+ length of stay may be as short as one to two days3, but it depends on your individual surgical outcome and your surgeon’s medical opinion.
Only your doctor can determine when you should resume your regular daily activities, but many AxiaLIF+ patients are active within a period of weeks.
The amount of pain that a patient will experience immediately following the procedure can vary. As with most spine surgeries, this discomfort will tend to diminish over time. In two separate patient studies, patients experienced a reduction in pain over time.2,3
Only your doctor can determine when you should resume your regular work activities.
Yes, please refer to this link for the comprehensive bibliography that includes more than fifty peer-reviewed medical studies demonstrating the safety and efficacy of AxiaLIF+.
AxiaLIF+ in the News
Animated Breakdown of the AxiaLIF+ Procedure
1. Rapp SM, Miller LE, Block JE. AxiaLIF system: Minimally invasive device for presacral lumbar interbodypinal fusion. Med Devices (Auckl). 2011;4:125-131. doi:10.2147/MDER.S23606.
2. Bradley WD, Hisey MS, Verma-Kurvari S, Ohnmeiss DD. Minimally invasive trans-sacral approach to L5-S1 interbody fusion: Preliminary results from 1 center and review of the literature. Int J Spine Surg. 2012;6:110-4. PubMed PMID: 25694879; PubMed Central PMCID: PMC4300883.
3. Marchi L, Oliveira L, Coutinho E, Pimenta L. Results and complications after 2-level axial lumbar interbody fusion with a minimum 2-year follow-up. J Neurosurg Spine. 2012 Sep;17(3):187-92. PubMed PMID: 22803626.
4. Tobler WD, Gerszten PC, Bradley WD, Raley TJ, Nasca RJ, et al. Minimally invasive axial presacral L5-S1 interbody fusion: two-year clinical and radiographic outcomes. Spine (Phila Pa 1976). 2011 Sep 15;36(20):E1296-301. PubMed PMID: 21494201.
5. Aryan HE, Newman CB, Gold JJ, Acosta FL Jr, Coover C, Ames CP..2008. Percutaneous axial lumbar interbody fusion (AxiaLIF) of the L5-S1 segment: initial clinical and radiographic experience. Minim Invasive Neurosurg. 51(4):225-30. Pubmed PMID: 18683115.
6. Gerszten PC, Tobler W, et al. Axial presacral lumbar interbody fusion and percutaneous posterior fixation for stabilization of lumbosacral isthmic spondylolisthesis. J Spinal Disord Tech 25(2):E36-40, 2012.
7. Tobler WD, Gerszten PC, et al. Minimally invasive axial presacral L5-S1 interbody fusion: two-year clinical and radiographic outcomes. Spine 36(20):E1296-1301, 2011.
8. Whang PG, Sasso RC, et al. Comparison of axial and anterior interbody fusions of the L5-S1 segment: a retrospective cohort analysis. J Spinal Disord Tech 26:437-443, 2013.
AxiaLIF is a registered trademark of Quandary Medical LLC. Quandary Medical LLC holds multiple patents related to the methods and apparatuses associated with AxiaLIF.
Indication for use: AxiaLIF System is intended to provide anterior stabilization of the L5-S1 spinal segment (s) as an adjunct to spinal fusion. The system is indicated for patients requiring fusion to treat pseudoarthrosis (unsuccessful previous fusion), spinal stenosis, spondylolisthesis (Grade 1 or 2 if single-level: Grade 1 if two-level), or degeneration disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Its usage is limited to anterior supplemental fixation of the lumbar spine at L5-S1 or L4-S1 in conjunction with use of legally marketed posterior fixation such as facet screw or pedicle screw systems at the same levels that are treated with system.