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Research ArticleArticle
Open Access

Clinical Outcomes of a Polyaxial Interspinous Fusion System

Joseph A. Sclafani, Kevin Liang, Donna D. Ohnmeiss and Charles Gordon
International Journal of Spine Surgery January 2014, 8 35; DOI: https://doi.org/10.14444/1035
Joseph A. Sclafani
1Milestone Research Organization
MD
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Kevin Liang
1Milestone Research Organization
Ph.D
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Donna D. Ohnmeiss
2Texas Back Institute
Dr. Med.
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Charles Gordon
3Precision Spine Care
MD
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    Fig. 1

    An interspinous process fusion device demonstrating polyaxial properties.

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    Table 1

    Summary of patient demographics

    n
    No. patients53
    Age at surgery60 years
    Sex (Male:Female)24:29
    Initial Diagnosis
    Spinal Stenosis24
    Herniated Disc10
    Spondylolisthesis5
    Follow-up period (average)22 months
    Follow-up rate94% (50/53)
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    Table 2

    Pre- and postoperative pain scores collected through a retrospective chart review. Outcome scores were collected at a minimum 1 year postoperative time point. Note that there was a significant improvement in the overall pain score in all groups except for patients with a low (<5/10) preoperative pain score. All surgical indications other than primary disc herniation had significant improvement in overall pain score after interspinous process fusion.

    Preoperative Pain ScorePostoperative Pain ScorePaired t-test p value
    Overall7.2 ± 1.74.5 ± 2.80.0001*
    Male7.1 ± 1.84.2 ± 2.90.001*
    Female7.2 ± 1.64.7 ± 2.80.001*
    Age > 597.3 ± 1.95.3 ± 3.00.05*
    Age ≤ 597.1 ± 1.63.9 ± 2.60.001*
    Preoperative pain ≥ 8/108.5 ± 0.75.0 ± 3.10.0001*
    Preoperative pain < 5/104.4 ± 0.84.4 ± 2.5> 0.05
    BMI ≥ 307.4 ± 1.55.4 ± 2.80.01*
    BMI < 307.1 ± 1.84.0 ± 2.70.0001*
    Diagnosis
    Stenosis7.4 ± 1.54.5 ± 2.80.0001*
    Herniated Disc7.0 ± 2.04.8 ± 3.3> 0.05
    Spondylolisthesis7.8 ± 1.63.2 ± 3.10.01*
    Operative Level
    L2-37.0 ± 1.25.8 ± 1.1> 0.05
    L3-47.4 ± 2.14.5 ± 3.3> 0.05
    L4-57.5 ± 1.44.3 ± 2.40.001*
    L5-S15.9 ± 1.73.8 ± 3.3> 0.05
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    Table 3

    Representation of successful Macnab outcome scores (excellent or good) by patient demographics, diagnosis and operative level. There was not a significant difference in success when stratified by gender, diagnosis or operative level. There was a significantly higher rate of surgical success in patients aged over 59 years compared to those less than 59 years old.

    Excellent/GoodFair/Poor
    Overall6/18 (48%)21/5 (52%)
    Male3/9 (55%)8/2 (43%)
    Female3/9 (43%)13/3 (57%)
    Age > 595/12 (59%)11/1 (41%)
    Age ≤ 591/6 (33%)10/4 (67%)
    Preoperative pain ≥ 8/105/7 (48%)10/3 (52%)
    Preoperative pain < 5/102/4 (67%)3/0 (33%)
    BMI ≥ 302/2 (24%)10/3 (76%)
    BMI < 304/16 (61%)11/2 (39%)
    Diagnosis:
    Stenosis3/10 (54%)9/2 (46%)
    Herniated Disc2/2 (80%)1/0 (20%)
    Spondylolisthesis0/3 (33%)6/0 (67%)
    Operative Level
    L2-30/0 (0%)3/1 (100%)
    L3-42/4 (55%)5/0 (45%)
    L4-52/9 (55%)8/1 (45%)
    L5-S11/3 (57%)3/0 (43%)
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Clinical Outcomes of a Polyaxial Interspinous Fusion System
Joseph A. Sclafani, Kevin Liang, Donna D. Ohnmeiss, Charles Gordon
International Journal of Spine Surgery Jan 2014, 8 35; DOI: 10.14444/1035

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Clinical Outcomes of a Polyaxial Interspinous Fusion System
Joseph A. Sclafani, Kevin Liang, Donna D. Ohnmeiss, Charles Gordon
International Journal of Spine Surgery Jan 2014, 8 35; DOI: 10.14444/1035
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  • clinical outcome
  • minimally invasive spine surgery

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