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Recent CommentsLowTop Pedicle Screw: Added Flexibility for Spinal Disorder Treatment?
March 25, 2008
Spine surgeons are constantly looking for additional flexibility with next generation technology to treat a broad range of deformities and physical anatomies. Is the LowTop pedicle screw system by Pioneer Surgical Technology significantly better than currently available products? When will it be on the market?
Answer:
The LowTop pedicle screw system is designed to be a user-friendly product. It has a ‘no torque’ locking feature and includes poly axial and fixed screws in a range of pre-assembled size ranges. The poly axial screw system can be locked in any position during the procedure, allowing for compression, distraction and rod rotation prior to the final lock.
Pioneer CEO Matthew N. Songer, M.D. said the product
“holds great promise in offering spine surgeons additional flexibility . . . to treat a broad range of deformities and physical anatomies.”
The Food and Drug Administration (FDA) granted clearance to Pioneer Surgical Technologies to market the LowTop system in March, and it is expected to hit markets later on this year.
Vertebroplasty: Evidence for Effectiveness?
March 18, 2008
Vertebroplasty can greatly improve the quality of life for osteoporosis patients. Are there any recent studies, though, which provide evidence for the minimally invasive treatment’s safety, effectiveness and low-complication rate?
Editor’s Note:
Vertebroplasty, the injection of medical-grade bone cement into a fractured vertebra, shores up the fracture similar to an internal cast and provides pain relief. It is indicated for painful vertebral compression fractures that fail to respond to conventional medical therapy, such as minimal or no pain relief with analgesics or narcotic doses that are intolerable.
Answer:
A study regarding the efficacy of vertebroplasty was recently reported at the Society of Interventional Radiology Scientific Meeting recently.
The study followed 884 osteoporosis patients who were treated with vertebroplasty for five years, and found that the procedure significantly decreased pain and improved functional ability. Pain scores were reduced from 7.9 (out of 11) pretreatment to 1.3 after treatment. Patients’ abilities to perform daily tasks also improved - a written survey found a decrease in disability from 69 percent to 13.5 percent.
“These data provide good news for physicians and osteoporosis patients. Many osteoporosis patients with compression fractures are in terrible pain and have a greatly diminished ability to perform basic daily activities, such as dressing themselves,” said Giovanni C. Anselmetti, M.D., interventional radiologist at the Institute for Cancer Research and Treatment in Turin, Italy.
The study also showed that vertebroplasty does not increase the risk of fracture in nearby vertebra. “Vertebroplasty is already known to be a safe and effective treatment for osteoporotic vertebral fractures. Osteoporosis patients remain susceptible to new fractures, which often occur in the contiguous vertebra to an existing fracture. Our large-scale study shows that vertebroplasty does not increase the risk of fracture in the level contiguous to previously treated vertebra and that these new fractures occur at the same rate as they would in osteoporosis patients who did not have vertebroplasty,” added Anselmetti.
Source: Abstract 182, “Percutaneous Vertebroplasty in the Osteoporotic Patients: Five Years Prospective Follow-up in 884 Consecutive Patients,” can be found at http://www.SIRmeeting.org.
Aleutian Spacer Systems Fully Launched
March 15, 2008
K2M, Inc announced the successful evaluation and launch of the ALEUTIAN AN (Anatomically Narrow) and the ALEUTIAN Anterior - Lumbar Spacer Systems. The ALEUTIAN family incorporates a full array of Spacer Systems, which include the Anterior - Lumbar, Small - Anterior, Posterior - Lumbar 10 x 22, Posterior - Lumbar 10 x 26, Posterior - Lumbar 10 x 27 and AN (Anatomically Narrow).ALEUTIAN incorporates a full range of anatomically designed spacers to address varying surgical approaches and different parts of the spine. ALEUTIAN features a durable and biocompatible material called PEEK-OPTIMA®; the radiolucent feature of which has the potential to increase visualization of the graft and allow for more accurate fusion assessment and placement. In addition, the elastic modulus more closely matches that of cortical bone for load sharing, with the potential to minimize stress shielding. The bulleted nose allows for easier insertion and distraction; and the self-retaining teeth can potentially help post operative stabilization of the implant. The family of ALEUTIAN Spacer Systems is available with a complete offering of additional preparation and insertion instruments, including the innovative ALEUTIAN Adjustable Inserter, which easily articulates as the implant advances into the spine during surgery. This unique instrument increases the potential for a shorter, more simplified surgery.
“We are pleased to launch the final two components of the ALEUTIAN family of Spacer Systems. This marks another important step in our development of a complete portfolio of unique, next generation products,” stated Eric Major, K2M’s President and CEO. “We continue to focus on the complex spine segment of the market and strive to be the leading provider of innovative products for treating the most difficult clinical challenges facing surgeons in the operating theater.”
“The ALEUTIAN Spacer System provides a complete product offering which combines the unique PEEK implant designs with special instruments that allow surgeons many options during surgery,” stated Paul Brisson, MD, Chief, Division of Orthopaedic Surgery at The Brooklyn Hospital Center. “This system includes innovative instrument designs allowing for both minimally invasive and traditional open surgical approaches, providing extensive versatility in one product.”
Charite Artificial Spinal Disc Design To Be Tweaked
March 7, 2008
The Charite artificial spinal disc, manufactured by Johnson & Johnson, will be “tweaked” by the manufacturer.
A J&J spokesman says the problem is not with the clinical efficacy of the Charite, but with Medicare reimbursement. They state that a lack of clinical data regarding Charite’s performance has resulted in problems with Medicare payment.
But some surgeons have stated that the design is flawed. Complaints about a faulty center of rotation and post surgical problems with the implant have been reported. In a Congressional hearing, ethical conflicts associated with surgeons receiving payment from manufacturers were discussed.
The Charite is composed of two cobalt chromium endplates that are surgically attached to the vertebrae of the diseased segment. The native disc is removed, and a flexible polyethylene core is inserted between the plates. The core is designed to replace the diseased disc and allow for separation of the vertebrae, normal range of motion and flexibility of the spine.
The product was the first of its kind on the market when released. A competing product manufactured by Synthes Inc is similar in design.
Source: Reuters
http://www.reuters.com/article/email/idUSN0626513720080307