What's New
Baxano iO-Flex
For patients suffering from pinched nerves, back pain, shooting leg pains or stenosis there is a new device which Dr. Pazmino can offer here at SpineCal to un-pinch those nerves. Using the Baxano iO-Flex Dr. Pablo Pazmino is able to access areas with his lumbar decompressions we thought were inaccessible via standard instruments. If you look closely the Baxano iO-Flex is a file with small teeth on one side of the device. Using this special file Dr. Pablo Pazmino is able to reshape the natural bone during your lumbar decompression.
This is performed in three essential steps. First Dr. Pablo Pazmino safely inserts the instrument in the foramen (hole where the nerve lives). Next Dr. Pazmino confirms the nerve is nowhere near the instruments teeth. Finally in step three he proceeds to reshape the foramen using the Baxano iO-Flex and in doing so gives your nerves the room they require to be completely and thoroughly decompressed. Call or email us at SpineCal to see if you qualify for this new technique of Lumbar decompression.
OptiMesh Deployable Grafting System
Patients with back pain may be interested to know that Dr. Pablo Pazmino now offers a new minimally invasive method of bone graft insertion through a Percutaneous minimally invasive approach. OptiMesh is a three-dimensional deployable mesh pouch that's implanted into stable vertebral body defects empty, through a small tube, and then deployed to its full size once it’s in place. This enables Dr. Pablo Pazmino to treat these defects minimally invasively or even percutaneously.
The principal purpose of OptiMesh is to contain bone graft (1500 series implants) in order to control its placement: Keep the graft where it’s supposed to be; where it was placed.
The OptiMesh can be placed percutaneously
Under the microscope you can see the OptiMesh implant and granular bone graft conform to the host bone bed. New bone grows through the pores of the OptiMesh implant (model; mesh is stained black in this slice). Call or email us at SpineCal to see if you qualify for this new Percutaneous technique of Lumbar bone graft insertion.
Nuvasive Brigade
This Nuvasive Brigade Cage is used during Anterior Lumbar Interbody Fusions (ALIF) by Dr. Pablo Pazmino. Dr. Pablo Pazmino uses this cage at times because it has four screws within the Poly Ether Ether Ketone (PEEK) cage which secure it to the bone. The cage comes in a variety of widths and dimensions allowing Dr. Pablo Pazmino to customize the cage to suit the patient.
Dr. Pablo Pazmino is able to secure the screws to the vertebral bodies above and below using their threaded taper block single step locking mechanism as seen here below.
This is the final construct once between the vertebral bodies which allows for a restoration of disc height and lordotic curvature. Call or email us at SpineCal to see if you qualify for this new technique of Lumbar fusion using the Nuvasive Brigade.
Interlock
For certain patients interested in a new way of performing a neck fusion or Anterior Cervical Discectomy and Fusion…..Dr. Pablo Pazmino now offers the Nuvasive Cervical Interlock. After the prior diseased disc is removed, Dr. Pablo Pazmino inserts the Poly Ether Ether Ketone (PEEK) spacer into the space between the bones.
Next Dr. Pablo Pazmino picks the custom sized implant to meet your specific anatomy.
Once Dr. Pazmino selects the implant that meets the depth, height and width of your prior disc space he mounts the Nuvasive Interlock device and prepares to insert it. This is how the cage will look once it is placed within the bones of your neck.
Next Dr. Pazmino secures the Interlock cage to your bones with the correct screw length.
Dr. Pazmino is able to lock the screws within the cage itself underneath a 360 degree circumferential locking ledge.
Dr. Pazmino performs this entire procedure under Xray so the screw length and cage size can be custom matched to your anatomy.
The bone will heal through the PEEK spacer connecting the bone above the implant to the bone below the implant through this device.
As you can see this device allows Dr. Pazmino to remove the disc and place a new spacer with the screws inside the cage itself. This means in patients who qualify for this procedure they no longer need a plate anterior to the cage.
Call or email us at SpineCal to see if you qualify for this new technique of Anterior Cervical Discectomy and fusion.
Viper Percutaneous Fusion
VIPER™ is a cutting edge percutaneous fixation system with intuitive instrumentation that is fast, designed to minimize muscle trauma and requires only two skin incisions.
Implant Basics:
- The 5.5mm Titanium Polyaxial Screws are cannulated versions of the EXPEDIUM™ Polyaxial Screws
- Available in diameters of 6mm and 7mm with lengths of 35mm-55mm
- Single Inner Closure Mechanism
- The 5.5mm Pre-Lordosed Rods
- Specifically designed to be used with the VIPER instrumentation
- Available in lengths of 35mm-70mm in 5mm
Instrument Basics
- The VIPER System is a revolutionary instrument set enabling percutaneous procedures to be more intuitive while only requiring two 15mm incisions per side. The key instruments are the Screw Extensions and Unique Rod Holder.
PEEK Dynamic Rod
This pedicle-based, posterior rod is designed to provide reproducible semi-rigid fixation that closely replicates the natural load distribution of the lumbar spine for patients who undergo spinal fusion surgery.
The CD HORIZON LEGACY PEEK Rod utilizes rods that are made of Polyetheretherketone (PEEK), a semi-crystalline thermoplastic polymer that meets all biocompatibility requirements and has a long history of use in surgical implants. When combined with CD HORIZON® Spinal System-based pedicle screws and minimally invasive approach options such as the MAST QUADRANT™ Retractor System, the CD HORIZON LEGACY PEEK Rod dynamically stabilizes the affected segment while allowing for a streamlined surgical technique that preserves much of the natural anatomy.
The CD HORIZON LEGACY PEEK Rod is suited for stabilizing the spine following interbody structural graft support. This "tension band" approach is based on Wolff's Law that bone forms where it is needed.
Some of the benefits of this include:
*Reduced stress on the screw-bone anchor points and construct instrumentation
*Better stress distribution throughout the construct potentially resulting in reduced risk of construct failure
*PEEK material is radiolucent reducing scatter and artifact in images allowing for better patient follow-up, especially within fusion assessment through CT / MRI
Kyphoplasty
A Vertebral Compression Fracture may be caused by osteoporosis (an age-related softening of the bones) or by the spread of tumor to the vertebral body. Certain forms of cancer can also weaken bone and cause the same problems.
Kyphoplasty is not appropriate for:
- Patients with young, healthy bones or those who sustained a vertebral body fracture or collapse in a major accident
- Patients with spinal curvature such as scoliosis or kyphosis that results from causes other than osteoporosis
- Patients who suffer from spinal stenosis or a herniated disk with nerve or spinal cord compression and loss of neurologic function not associated with a compression fracture.
STALIF Cervical
The latest stand-alone anterior lumbar fusion cage implant used in spinal surgery from Surgicraft (Figure 1) is manufactured from biocompatible polyetheretherketone (PEEK-OPTIMA, Invibio Ltd, Thornton, UK). The benefits this implant offers include reduced operating times, better bone fusion, restoration of height, and improved spinal alignment. We achieve this in a number of ways.
- The surgeon places the STALIF implant between vertebrae where it serves as a substitute for degenerative spinal discs. It can simply be inserted into place between the vertebral bodies and the screws hold it in place.
- In mechanics, Young's modulus (E) is a measure of the stiffness of a given material. The Young’s Modulus of PEEK is similar to that of cortical bone, therefore, it offers more elasticity than metal. It can absorb energy, handle the normal weight of the body and minimise stress on adjacent levels. The material is also radiolucent (unseen on X-rays) and thereby allows an improved view of the fusion mass that is taking place. However, to be able to offer X-ray (computer tomography or magnetic resonance) imaging for optimal positioning and postoperative assessments, titanium trace wires are press fitted into the implant*.
- Recovery for the patient is faster in many cases. Some patients need to be operated on from the back. However, the implant can be inserted through the patient’s stomach where reconstructing the spine is much less invasive. Some patients only need a small incision from the front or side, and in these cases recovery can be rapid, requiring only a two- or four-day hospital stay followed by a period of recuperation to allow for fusion to occur.
References:
http://paradigmbiodevices.com/press1.html
Prodisc-Lumbar Arthroplasty
Dr. Pazmiño has brought his orthopaedic subspecialty expertise in arthroplasty of the hip, knee and shoulder, elbow, ankle and wrist to the spine with lumbar arthroplasty. What is it? The PRODISC®-L Total Disc Replacement is an artificial intervertebral disc made from metal and plastic that is used to treat pain associated with degenerative disc disease (DDD). DDD is defined as discogenic back pain (pain resulting from a degenerated intervertebral disc) with degeneration of the disc confirmed by patient history and radiographic studies.
The PRODISC®-L Total Disc Replacement is implanted to replace a diseased or damaged intervertebral disc during a surgical procedure called spinal arthroplasty.
How does it work? The PRODISC®-L Total Disc Replacement consists of three parts:
- Two metal (cobalt-chrome alloy) endplates that are anchored to the top and bottom surfaces of the spinal bones (vertebrae)
- A plastic (ultra-high molecular weight polyethylene, or UHMWPE) inlay that fits between the two endplates
The plastic inlay and endplates help restore the natural distance between the two vertebrae (disc height). The top (superior) endplate can slide over the domed part of the inlay, which can allow movement at the level where it is implanted.
When is it used? The PRODISC®-L Total Disc Replacement is indicated for spinal arthroplasty in patients who:
- are skeletally mature
- have degenerative disc disease (DDD) at one level in the lumbar spine (from L3-S1)
- have no more than Grade 1 spondylolisthesis at the involved level
- have had no relief from pain after at least six months of non-surgical treatment
What will it accomplish? The PRODISC®-L Total Disc Replacement is used to replace a damaged intervertebral disc. The device may restore disc height, may reduce pain, and may allow movement at the level where it is implanted.
The ProDisc was designed in the late 1980's by Thierry Marnay, a French Orthopaedic Spine Surgeon. Marnay implanted this artificial disc into 64 patients. In 1999, these patients were studied to determine the long-term results of implantation. Three of these patients had died from unrelated causes, but 58 of the surviving 61 patients (95%) were found and studied extensively at 7-11 year follow-ups. All implants were intact and functioning. There had been no implant removals, revisions, or failures.
There was no evidence of subsidence (sinking or settling in bone) on follow-up radiographs compared to the peri-operative films, as reported by the operating surgeon as well as by an independent US Orthopaedic spine surgeon. A significant (p <0.001) reduction in patient-reported back pain and leg pain was identified. 92.7% of these patients were "satisfied" or "extremely satisfied" with the procedure.
Two-thirds of these patients had single level implants while one-third had two level ProDiscs. There was no outcome difference between the 1 and 2 level ProDisc implantations. Most importantly, at this long-term follow-up, there were no device-related safety issues, no untoward effects, no complications, and no adverse events. The ProDisc is based on spherical articulations. It has metal endplates made of a cobalt chromium molybdenum alloy (CoCrMo).
Three components of the ProDisc
Assembled ProDisc
The convex bearing surface, snap-fit into the inferior end plate, is made of ultra-high molecular weight polyethylene (UHMWPE). The artificial disc is attached through a large central keel and two spikes on each endplate. Physiologically, the ProDisc matches the range of motion in flexion, extension, axial rotation, and lateral bending as a normal spine.
The device is modular, so Dr. Pazmiño can customize the device to each patient's unique anatomic and physiologic requirements. There are two endplate sizes (medium and large), three heights of the polyethylene component (10, 12, and 14 mm), and two lordosis angles (6 and 11 degrees).
The implantation instrumentation is straightforward and user-friendly. Minimal access approaches to the lumbar spine, (typically through a mini-retroperitoneal approach) are possible given the streamlined design of the instrumentation.
The endplates are inserted in a collapsed form, so that over-distraction of the disc space is not required. Only after the metal endplates are seated in the vertebral bodies the disc space distracted. Dr. Paqzmiño then appreciates the soft tissue tension, and inserts an appropriately-sized UHMWPE implant within the disc space, snap-fitting it into the lower metal endplate to complete the assembly process within the body.
The ProDisc has been implanted in over 8000 patients in Europe since December 1999. A multicenter FDA study was started in the United States in October 2001. The first ProDisc in the United States was implanted at the Texas Back Institute on October 3, 2001. The ProDisc-L was approved by the U.S. FDA on August 14, 2006 for use at a single vertebral level.
Prestige Cervical Arthroplasty
Click here to download the movie
The PRESTIGE® Cervical Disc is an artificial disc replacement which is designed to maintain motion for patients suffering from the symptoms of degenerative cervical disc disease or acute unresolved cervical disc herniation.
Dr. Pazmiño has brought his orthopaedic subspecialty expertise in arthroplasty of the hip, knee and shoulder, elbow, ankle and wrist into the cervical spine with cervical arthroplasty.
With the PRESTIGE® Cervical Disc Arthroplasty we can now offer our patients with radiculopathy and myelopathy <link these two words to my definitions on my f.a.q> related to traumatic or degenerative cervical disc disease (DDD) in the cervical spine an alternative to spinal fusion. Designed by Medtronic spine the disc replacement is constructed of stainless steel in a unique, two-piece ball-and-trough configuration. The disc replacement is designed to maintain motion at throughout the cervical spine.
Each vertebra in the spine is separated by a shock absorbing disc, which is made up largely of water. These discs lose water content because of disease, injury or age (over the age of 20), they compress, or lose height, which causes the vertebrae to move closer together. This reduces the disc's shock absorbing qualities, which may lead to bone spurs and narrowing of the nerve openings. On the other hand if a disc ruptures, it can place pressure on the surrounding nerve roots and the spinal cord, resulting in pain, numbness and/or weakness.
Dr. Pazmiño may recommend surgery if non-surgical treatment fails to provide relief from these symptoms. Before 1991 an anterior cervical discectomy with fusion (ACDF) had been the "gold standard" for surgically treating disc disease in the cervical spine. We used bone grafts and instrumentation such as metal plates and screws in order to fuse, or creates a bond between, two or more adjacent vertebrae. This is still a viable option as it stabilizes the spinal segment at hand and provides many with relief. Many of our patients have achieved excellent results with ACDF; however, a potential disadvantage associated with spinal fusion is the loss of motion and flexibility in the treated vertebral segment.
Dr. Pazmiño may recommend surgery if non-surgical treatment fails to provide relief from these symptoms. Before 1991 an anterior cervical discectomy with fusion (ACDF) had been the "gold standard" for surgically treating disc disease in the cervical spine. We used bone grafts and instrumentation such as metal plates and screws in order to fuse, or creates a bond between, two or more adjacent vertebrae. This is still a viable option as it stabilizes the spinal segment at hand and provides many with relief. Many of our patients have achieved excellent results with ACDF; however, a potential disadvantage associated with spinal fusion is the loss of motion and flexibility in the treated vertebral segment.
The PRESTIGE® Cervical Disc replaces a diseased or damaged disc and is designed to maintain motion. Made of stainless steel, the device has two articulating components (a ball on top and a trough on the bottom) that are inserted into the disc space and attached to the vertebral bodies on either side. The PRESTIGE® Cervical Disc was designed to allow for the following motions of a natural intervertebral disc: flexion, extension, side bending and rotation.
The PRESTIGE® Cervical Disc is available in a variety of sizes that allow Dr. Pazmiño to closely match a patient's anatomy.
While many factors contribute to the longevity of an artificial disc, the PRESTIGE® Cervical Disc has undergone significant testing to verify the safety and adequate durability of the device.
Clinical Research
Last year Dr. Pazmiño was a subinvestigator in the two level PRESTIGE® Cervical Disc Arthroplasty IDE FDA Clinical Trial.
In the largest clinical trial of its kind, the single level PRESTIGE® Cervical Disc proved to be a safe, effective alternative to fusion for patients with degenerative disc disease in the cervical spine.
The PRESTIGE® Cervical Disc, used in a procedure called cervical disc arthroplasty, or cervical artificial disc replacement, has been studied rigorously. Its safety and effectiveness as an alternative to anterior cervical discectomy with fusion (ACDF) for the treatment of degenerative disc disease (DDD) with myelopathy or radiculopathy has been evaluated in a Level 1, multi-center prospective randomized controlled study that involved 541 patients — the most extensive clinical study of its kind ever conducted and completed for the cervical spine.
The goal of the PRESTIGE® Cervical Disc clinical trial was to compare the outcomes associated with cervical artificial disc replacement with the PRESTIGE® Cervical Disc and ACDF. It was conducted at 32 study sites across the United States and treatment took place between October 2002 and August 2004. Patients in the study, who had to be at least 18 years of age with documented DDD conditions/symptoms with associated neurologic involvement that had not responded to non-surgical treatment for at least 6 weeks, were randomly assigned to the PRESTIGE® Cervical Disc or ACDF investigational groups.
- 276 patients in the PRESTIGE® Cervical Disc study group received an anterior cervical discectomy and decompression followed by placement of the PRESTIGE® Cervical Disc.
- 265 patients in the fusion control group received an anterior cervical discectomy and decompression with the placement of an interbody ring allograft and the ATLANTIS® CervicalPlate System (also by Medtronic).
- Patients in both groups underwent tightly-controlled radiographic and clinical examinations pre-operatively, and at routine follow-up periods post-operatively.
According to the study, patients who underwent cervical artificial disc replacement with the PRESTIGE® Cervical Disc achieved equivalence to all treatment outcome parameters and superiority in neurologic success and overall success at 24 months, compared to the outcomes of patients in the ACDF treatment group.
Some key findings of the PRESTIGE® Cervical Disc clinical trial include:
- At the 12 and 24 months follow-up points, the PRESTIGE® Cervical Disc patient group reported more improvement in their neck pain and a greater ability to go about their daily activities than the fusion control group.
- Patients receiving the PRESTIGE® Cervical Disc maintained sagittal (front and back) angular motion averaging more than 7 degrees in the normal physiologic range of motion. Pre-operatively, the PRESTIGE® Cervical Disc group had a mean angular motion of 7.55 degrees, which increased to an average of 7.59 degrees at 12 and 24 months post-operatively.
- On average, patients receiving the PRESTIGE® Cervical Disc had a median return to work that was 16 days faster than those in the ACDF treatment group.
According to the study, patients who underwent cervical artificial disc replacement with the PRESTIGE® Cervical Disc achieved equivalence to all treatment outcome parameters and superiority in neurologic success and overall success at 24 months, compared to the outcomes of patients in the ACDF treatment group. - Patients in the PRESTIGE® Cervical Disc group experienced no implant failures or migrations.
- Fewer patients in the PRESTIGE® Cervical Disc group required secondary surgical procedures than those in the ACDF investigational group.
Prodisc-Cervical Arthroplasty
The ProDisc-C total disc replacement has been determined to be safe and effective in the treatment of intractable symptomatic cervical disc disease (SCDD) at one level from C3 to C7. The ProDisc-C total disc replacement surgery is intended to:
- Remove the diseased disc
- Restore normal disc height
- Decompress surrounding neural structures
- Potentially provide motion in affected vertebral segment
- Improve patient function
- Controlled and predictable motion
- Fixed center-of-rotation
- Coupled motion: translation with rotation
- Prevents pure anteroposterior shear to protect posterior anatomical structures
- Patented central keel provide secure primary fixation
- Plasma-sprayed titanium coating on bone contacting surfaces promotes bony on-growth
- Implant does not contact anterior soft tissue structures after implantation
- 18 anatomical sizes facilitate an accurate match with the patient’s anatomy
- 6 footprints
- 3 heights (5, 6 and 7 mm)
- Three step implantation technique
- Enables accurate sizing and precise placement of the implant
Design Philosophy
The ProDisc-C implant has been designed to maintain the physiological range of motion in the spine. The implant was developed using the clinically proven ball and socket concept used in joint replacement implants for over 40 years. The ProDisc-C implant is composed of three components – two cobalt chrome alloy (CoCrMo) endplates and an ultra-high molecular weight polyethylene (UHMWPE) inlay and is inserted into the vertebral bodies en bloc.
The key features of the ProDisc-C design philosophy are:
Ball and socket design
Secure fixation with zero profile
Anatomic Sizing
Safe and reproducible surgical technique