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Research ArticleSpine
Open Access

A Randomized Trial Comparing 2 Techniques of Balloon Kyphoplasty and Curette Use for Obtaining Vertebral Body Height Restoration and Angular-Deformity Correction in Vertebral Compression Fractures due to Osteoporosis

L. Bastian, F. Schils, J.B. Tillman and G. Fueredi on behalf of the SCORE Investigators
American Journal of Neuroradiology March 2013, 34 (3) 666-675; DOI: https://doi.org/10.3174/ajnr.A3363
L. Bastian
aFrom the Klinikum Leverkusen (L.B.), Leverkusen, Germany
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F. Schils
bDepartment of Neurosurgery (F.S.), Clinique Saint Joseph, Liège, Belgium
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J.B. Tillman
cMedtronic Spine LLC (J.B.T.), Sunnyvale, California
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G. Fueredi
dAurora Memorial Hospital of Burlington (G.F.), Burlington, Wisconsin.
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    Fig. 1.

    Patient accountability.

  • Fig. 2.
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    Fig. 2.

    Primary end point of absolute height restored at index vertebrae as a percentage of adjacent normal vertebrae. Group means and 95% confidence intervals are shown for measurements at the posterior, anterior, and midpoint of index vertebral bodies for each group at baseline and at 48 hours postoperatively by using standing lateral x-ray films.

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    Fig. 3.

    Index vertebral body height gain in millimeters. CF (A) and IBTF (B) group means and 95% confidence intervals are shown for vertebral body height improvement (compared with preoperative) in millimeters, measured at the posterior, anterior, and midpoint of index vertebral bodies after prone positioning (postural reduction), IBT inflation, cementation, and postoperative steps. Preoperative and postoperative assessments used standing lateral x-rays, and intraoperative assessments used lateral fluoroscopic images.

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    Fig. 4.

    Index vertebral body kyphosis angle. CF (A) and IBTF (B) group means and 95% confidence intervals are shown for kyphotic angulation improvement (compared with preoperative) of index vertebral bodies measured as the angle between the inferior and superior endplates of index vertebrae after prone positioning (postural reduction), IBT inflation, cementation, and postoperative steps. Preoperative and postoperative assessments used standing lateral x-rays, and intraoperative assessments used lateral fluoroscopic images.

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    Fig. 5.

    Case illustration of kyphosis correction for each step in the kyphoplasty procedure. A, Preoperative T2 short-τ inversion recovery MR imaging. B, Preoperative standing x-ray. C, Intraoperative postural reduction without bolsters. D, Intraoperative postural reduction with a bolster. E, Intraoperative first balloon inflation. F, Intraoperative curette and second balloon inflation. G, Intraoperative cement placement. H, Postoperative standing x-ray.

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    Fig. 6.

    Case illustration of a nonmobile fracture. A, Preoperative standing x-ray. B, Intraoperative postural reduction with a bolster. C, Intraoperative first balloon inflation. D, Intraoperative curette and second balloon inflation. E, Intraoperative cement placement. F, Postoperative standing x-ray.

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    Fig. 7.

    Case illustration of nonmobile fracture and use of curette. A, Intraoperative postural reduction with a bolster. B, Intraoperative first balloon inflation. C, Intraoperative curette usage (used bilaterally but image shows use only on 1 side). D, Intraoperative second balloon inflation. E, Anteroposterior (AP) film of C. F, AP film of D. G, Intraoperative cement placement. H, Postoperative standing x-ray.

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    Fig. 8.

    Postoperative back pain and ambulation. A, Group means and 95% confidence intervals are shown for the back pain numeric rating scale (0–10) measured at baseline and discharge. Paired t test P values for comparison with baseline are shown for each group. B, Percentage of patients in each ambulation category is shown for baseline and at discharge for each group. Stuart-Maxwell P values comparing postoperative status with baseline are shown for each kyphoplasty group.

Tables

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    Table 1:

    Baseline patient demographics

    CharacteristicCFIBTF
    No. of patients evaluablea5755
    Age (yr) (mean)73.6 ± 8.476.0 ± 9.4
    Weight in kg (mean)71.0 ± 16.271.8 ± 16.3
    Height in cm (mean)162.1 ± 8.3162.2 ± 8.8
    Female (No.) (%)47 (82.5)41 (74.5)
    Ethnicity (No.) (%)
        Caucasian55 (96.5)55 (100.0)
        Hispanic1 (1.8)0 (0)
        Middle Eastern1 (1.8)0 (0)
    Smoking history (No.) (%)
        Never36 (63.2)36 (65.5)
        Former14 (24.6)14 (25.5)
        Current7 (12.3)5 (9.1)
    Index fracture age (wk) (median) (IQR)4.0 (2.0, 9.0)5.0 (3.0, 8.0)
    Index vertebral body location (No.) (%)
        T5-T97 (12.3)6 (10.9)
        T10-L242 (73.7)37 (67.3)
        L3-L58 (14.0)12 (21.8)
    Index fracture morphometry (No.) (%)b
        Wedge38 (66.7)34 (61.8)
        Crush4 (7.0)4 (7.3)
        Concave15 (26.3)17 (30.9)
    Prior symptomatic VCF (No.) (%)b
        044 (77.2)43 (78.2)
        15 (8.8)11 (20.0)
        22 (3.5)1 (1.8)
        36 (10.5)0 (0)
    • ↵a A total of 120 patients enrolled. Eight patients withdrew early, did not receive surgery, and, therefore, did not receive randomization assignment.

    • ↵b As determined by treating physicians.

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    Table 2:

    Procedure characteristics

    ProcedureaCFIBTF
    No. of patients treated5755
    Patients with mobile fracture (No.) (%)29 (50.9)28 (50.9)
    Procedure duration (min) (mean)33.5 ± 10.836.8 ± 12.5
    Fluoroscopy duration (min) (mean)3.8 ± 2.03.7 ± 3.3
    Anesthesia
        General49 (86.0)44 (80.0)
        Local8 (14.0)11 (20.0)
    Approach
        Extrapedicular3 (5.3)3 (5.5)
        Transpedicular54 (94.7)51 (92.7)
    Initial IBT inflation volume (mL)
        Left2.76 ± 1.212.52 ± 1.38
        Right2.86 ± 1.232.52 ± 1.45
    Initial IBT inflation pressure (PSI)
        Left167.3 ± 73.0168.5 ± 79.5
        Right169.9 ± 84.8159.5 ± 75.9
    Final IBT inflation volume (mL)
        Left2.79 ± 1.293.00 ± 1.48
        Right2.85 ± 1.353.03 ± 1.51
    Final IBT inflation pressure (PSI)
        Left164.1 ± 87.3151.8 ± 86.2
        Right157.6 ± 89.0138.6 ± 77.5
    Final cement volume (mL)
        Left2.78 ± 1.202.94 ± 1.16
        Right2.89 ± 1.253.00 ± 1.16
    Length of stay (hours)96.1 ± 153.977.5 ± 108.2
    • ↵a Thirteen patients in the curette-first group had an additional curettage and IBT inflation; 7 patients in the IBT-first group had a third IBT inflation.

    • View popup
    Table 3:

    Fracture characteristicsa

    Preoperative Fracture EvaluationCFIBTF
    No. of patients treated5755
    No. of fractures evaluable5654
    Fracture type
        Wedge47 (83.9)44 (81.5)
        Biconcave9 (16.1)10 (18.5)
        Crush0 (0)0 (0)
    Severity of fracture
        Slight13 (23.2)10 (18.5)
        Moderate21 (37.5)23 (42.6)
        Severe22 (39.3)21 (38.9)
    Vacuum cleft
        Absent43 (76.8)46 (85.2)
        Present13 (23.2)8 (14.8)
    Intraoperative evaluation
        No. of fractures evaluable5551
        Cement leakage absent46 (83.6)44 (86.3)
        Cement leakage present9 (16.4)7 (13.7)
        Disk86
        Epidural/foraminal10
        Paraspinal21
        Vascular21
         >15 mm10
    • ↵a Parameters assessed by radiographic core laboratory.

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American Journal of Neuroradiology: 34 (3)
American Journal of Neuroradiology
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Cite this article
L. Bastian, F. Schils, J.B. Tillman, G. Fueredi
A Randomized Trial Comparing 2 Techniques of Balloon Kyphoplasty and Curette Use for Obtaining Vertebral Body Height Restoration and Angular-Deformity Correction in Vertebral Compression Fractures due to Osteoporosis
American Journal of Neuroradiology Mar 2013, 34 (3) 666-675; DOI: 10.3174/ajnr.A3363

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A Randomized Trial Comparing 2 Techniques of Balloon Kyphoplasty and Curette Use for Obtaining Vertebral Body Height Restoration and Angular-Deformity Correction in Vertebral Compression Fractures due to Osteoporosis
L. Bastian, F. Schils, J.B. Tillman, G. Fueredi
American Journal of Neuroradiology Mar 2013, 34 (3) 666-675; DOI: 10.3174/ajnr.A3363
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