Here are findings from seven studies focused on spine or orthopedic medical devices.
1. Baxano Surgical's AxiaLIF procedure, a pre-sacral interbody fusion procedure, was compared to transforaminal lumbar interbody fusion in an analysis published in the Journal of Managed Care Medicine. According to the analysis, AxiaLIF lowered cost per procedure by $3,500 and shortened hospital stays.
2. ConforMIS announced results from a clinical study evaluating hospital outcomes and costs in patients undergoing total knee arthroplasty using ConforMIS iTotal customized knee implants compared with standard, off-the-shelf implants. According to the analysis, patients with the off-the-shelf implants had an adverse event rate of 13.9 percent, while the rate for patients with the ConforMIS implant was 1.6 percent.
3. VertiFlex announced that the two-year clinical results of the Superion Indirect Decompression System, compared with an alternative surgical control device, have been published in BMC Musculoskeletal Disorders. The study found that leg pain scores in the Superion Indirect Decompression System group of patients improved by more than 75 percent from baseline at two years.
4. A new study conducted by surgeons from Rady Children's Hospital in San Diego shows the Misonix BoneScalpel could reduce blood loss during adolescent idiopathic scoliosis correction surgery. The BoneScalpel limited overall blood loss by 30 percent to 40 percent.
5. Device company Paradigm Spine published two separate independent prospective clinical studies that examine the short- and long-term durability of coflex interlaminar stabilization. One study examined decompression alone in comparison to decompression supplemented with coflex interlaminar stabilization, and found a statistical improvement in outcomes of the coflex group over the decompression only group.
The second study study focused on outcome measures such as back pain improvement, functional stabilization of disc heights and foraminal volume with maintenance of dynamic motion at the index level of surgery. The study found significant improvement in each category for coflex patients.
6. VEXIM announced the results of an international clinical study on the clinical performance of SpineJack in treating acute traumatic vertebral compression fractures. Functional capacity was measured using the Oswestry Disability Index, and according to study results, there was an improvement of 86 percent in ODI scores at one year after SpineJack implantation, following an improvement of 81 percent at three months.
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