Spine
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Multicenter Study
One Year Outcomes From a Prospective Multicenter Investigation Device Trial of a Novel Conformal Mesh Interbody Fusion Device.
A prospective multicenter investigational device exempt trial is underway evaluating a novel conformable mesh interbody fusion device in subjects undergoing single-level fusion for degenerative disc disease. Patients meeting inclusion and exclusion criteria were offered enrollment. There is no comparative group in this study. ⋯ 12-month outcomes demonstrated excellent patient compliance and positive outcomes for pain, function, fusion, and device safety. Clinical improvements were observed by 6-weeks post-op and appear durable up to 1 year later. A novel mesh interbody device may provide an alternative means of interbody fusion that reduces connective tissue disruption.Level of Evidence: 3.
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Prospective cohort study. ⋯ The PROMIS-29 scale scores assessing pain intensity, physical function, and anxiety evidenced the most responsivity in the study sample. The results, when considered in light of the findings from other investigators, support 5.0 points as a reasonable MCID for most of the PROMIS-29 scales. Further studies are needed to determine the generalizability of the findings.Level of Evidence: 2.
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A 2-year follow-up review of 62 patients with severe rigid scoliosis (>120°). ⋯ For severe rigid scoliosis with a Cobb angle greater than 120°, a combination of short-term presurgical HPT and posterior surgery is an effective and safe solution. After 4 to 6 weeks of presurgical HPT the Cobb angle can be decreased by approximately 50%, providing a favorable condition for spine corrective surgery.Level of Evidence: 3.
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This is a multicenter retrospective review of 257 surgically treated consecutive ASD patients who had a minimum of five fused segments, completed a 2-year follow-up (53 ± 19 yrs, females: 236 [92%]). ⋯ In this multicenter study, in an Asian ASD patient cohort, the GAP score was not associated with the incidence of MF or revision surgery. Additional studies on the predictive ability of the GAP score in different patient cohorts are warranted.Level of Evidence: 3.