Validation and analysis of a multi-site MIS Prospective Registry through sub-analysis of an MIS TLIF Subgroup.

STUDY DESIGN: Retrospective analysis of multi-site, prospectively collected database. OBJECTIVE: To assess the validity and utility of a prospective spine registry by sub-analysis of patients treated with MIS TLIF. BACKGROUND: The MIS registry is a large-scale, multi-center series of prospectively collected clinical information on outcomes, complications, and adverse events for minimally invasive spine procedures for the treatment of degenerative lumbar conditions. METHODS: Analysis was performed on the MIS Prospective Registry database. A subgroup of patients treated by MIS TLIF technique was identified. Statistical analyses were performed on pre and post-operative data collected using validated health related quality of life outcome tools. Missing 1-year patient follow-up data was obtained through progressive correspondence modalities. RESULTS: Data analysis was performed on 98 MIS TLIF patients (56 female, 42 male) with a median age of 64.5 years (range 25-91 years) which were extracted from a total registry population of 478 patients. The one year follow-up rate was 87%. A total of 64 single-level, 23 two-level, 3 three-level, and 3 combined TLIFs staged with an MIS lateral procedure were included. The primary surgical indications were spondylolisthesis (27%), central stenosis (25%), foraminal stenosis (14%), post-laminectomy syndrome (14%) and degenerative scoliosis (6%). The peri-operative blood transfusion rate was 3%. Complications included intraoperative dural tear (n = 3), deep wound infection (n = 2), superficial dehiscence/cellulitis (n = 2). There was a 4% re-operation rate at the 1 year post-operative time point. Half of patients were discharged within 2 days (range 1-11 days, mean 2.97 days, median 2 days). All patients that were discharged on the first post-operative day (n = 14) underwent a single-level MIS TLIF procedure and had significantly lower pre-op disability index score than those discharged on POD 3-5 (43.7 ± 15.5 vs. 56.0 ± 18.3, p = 0.04). Average ODI scores in the subgroup of patients that had reached the one year postoperative time point were 46.5 pre-op (n = 46), and 26.2 at 1 year post-op (n = 40, p = 0.0001). There was significant improvement in VAS scores: pre-operative (back = 6.7, leg = 5.4, n = 46), and 1 year post-operative (back = 3.2, leg = 1.7, n = 40, p = 0.0001). Patients with pre-operative ODI scores greater than 50 demonstrated significant improvement starting at the 6 week post-operative time point (24 point improvement, n = 46, p < 0.001). A pre-operative ODI between 35-50 showed significant improvement starting at 3 months (15.5 point improvement, n = 29, p = 0.05). Patients with a pre-operative ODI score less than 35 had an initial period of increased disability with a trend towards significant improvement by 3 months post-op (n = 20). CONCLUSIONS: Initial findings of the MIS Prospective Registry show patients can be enrolled in a relatively short time period and patient based questionnaires can successfully be obtained through a combination of clinic follow-up appointments and remote correspondence. Outcomes of the MIS Registry MIS TLIF subgroup were consistent with previously published MIS TLIF studies. Sub-analysis of data collected through level-specific patient diagnosis and treatment modalities permits outcome analysis of a wide breadth of spinal conditions and interventions.

Use of vertebroplasty to prevent proximal junctional fractures in adult deformity surgery: a biomechanical cadaveric study.

BACKGROUND CONTEXT: Vertebral compression fractures at the proximal junction are common complications of long spinal fusion surgeries that can contribute to the development of proximal junctional kyphosis or proximal junctional failure. To our knowledge, no biomechanical studies have addressed the effect of vertebral augmentation at the proximal junction. PURPOSE: To evaluate the effectiveness of prophylactic vertebroplasty in reducing the incidence of vertebral compression fractures at the proximal junction after a long spinal fusion in a cadaveric spine model. STUDY DESIGN: Biomechanical cadaveric study. METHODS: We divided 18 cadaveric spine specimens into three groups of six spines each: a control group, a group treated with one-level prophylactic vertebroplasty at the upper instrumented vertebra, and a group treated with two-level prophylactic vertebroplasty at the upper instrumented vertebra and the supra-adjacent vertebra. In all spines, the pedicles were instrumented from L5 to T10. Using eccentric axial loading, the specimens were then compressed until failure. Failure was defined as a precipitous decrease in load with increasing compression. The effect of augmentation on load-to-failure was checked using linear regression. The effect of augmentation on incidence of adjacent fractures was checked using logistic regression. Differences at the level of p<.05 were considered significant. KyphX cement introducer was donated by Kyphon, and the pedicle screws were donated by DePuy. RESULTS: Fractures occurred in 12 of 18 specimens: five in the control group, six in the one-level group, and only one in the two-level group; these differences were statistically significant. CONCLUSIONS: Prophylactic vertebroplasty at the upper instrumented level and its supra-adjacent vertebra reduced the incidence of junctional fractures after long posterior spinal instrumentation in this axially loaded cadaveric model. Additional studies are necessary to determine if these results are translatable to clinical practice.

Provisional new syndrome of MR/MCA with evolving phenotype.

We report on a 10-year-old patient with a provisionally new syndrome of MR/MCA with an evolving phenotype. Major findings at birth included short umbilical cord; striking hypotonia and cutis laxa with increased OFC; facial abnormalities with epicanthal folds, telecanthus, mild hypertelorism, wide flat nasal bridge, hypoplastic nose with upturned nostrils, and low-set dysplastic ears; asymmetric deformed chest with prominent sternum and winged scapulae; wider thumbs and halluces; left cryptorchidism and unusual perianal creases. Chromosomal and metabolic studies were normal. With aging, the phenotype has changed significantly: cutis laxa disappeared, the perianal creases and hypotonia are much milder, the initial apparent macrocephaly turned out to be true microcephaly, broad thumbs are less evident, but skeletal anomalies are more striking. Unsuccessful extensive diagnostic searches since birth and presentation in meetings suggest the presence of a private syndrome.