SPINE
A prospective, double-blind, randomized controlled trial of treatment of atlantoaxial instability with C1 posterior arches >4 mm by comparing C1 pedicle with lateral mass screws fixation
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2016;4(15):26 BMC Musculoskelet Disord. 2016 Apr 14;17(1):164140 patients with atlantoaxial instability (AAI), with C1 posterior arches greater than 4mm, were randomized to undergo either C1 pedicle or lateral mass screw fixation. The purpose of this study was to compare the feasibility and clinical outcomes of the two treatments of AAI after a mean follow-up period of 24.5 months. Findings indicated that C1 pedicle screw fixation may be less invasive and yield fewer complications compared to C1 lateral mass screw fixation.
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
はい = 1
不確実＝0.5
無関係 = 0
いいえ = 0
報告基準評価では、著者が出版物内で試験の方法論的特徴や試験特性を報告する際の透明性を評価します。評価は以下の5つのカテゴリーに分類されます。
3/4
Randomization
4/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
Therapy Description
3/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Fragility Indexは、重要な所見の解釈を助けるツールで、結果の強さの尺度を提供します。Fragility Indexは、その所見が有意でなくなるために、二項対立の結果に追加する必要がある連続した事象の数を表します。数値が小さいほど弱い所見を表し、数値が大きいほど強い所見を表します。
なぜ今この研究が必要なのですか？
Atlantoaxial instability (AAI) is atypical movement at the cervical region, in between the atlas and axis, caused by malformation of bone or alterations of ligament. Atlantoaxial fixation is required to repair the instability, though various approaches that have been previously used, such as sublaminar wiring, Harms and Magerl techniques, have reported many postoperative complications followed by substantial rates of non-union. The Harms method utilizes polyaxial screws that are independently inserted into the C1 posterior arch and C2 pedicles, thereby allowing C1 posterior arch fixation to be split into pedicle and lateral mass screw fixation. The present study aims to compare the clinical outcomes of C1 pedicle and lateral mass screw fixation methods in treatment of AAI.
主な研究課題は何ですか？
In treatment of atlantoaxial instability, how do C1 pedicle and lateral mass screw fixation compare with regards to feasibility and clinical outcomes, as assessed up to 38 months postoperatively?
重要な知見は？
- A significantly shorter mean operation time was reported in the Pedicle screw group compared to the Lateral mass group (85 +/- 11 vs. 110 +/- 17 minutes, respectively; p<0.01).
- Significantly less volume of blood was lost in the Pedicle screw group compared to the Lateral mass group (180 +/- 40 vs. 370 +/- 80 ml, respectively; p<0.01)
- Hospitalization time, JOA scores, and VAS scores were similar between groups (p>0.05).
- JOA and VAS scores were significantly improved within both groups from preoperation to final follow-up (both p<0.01).
- No postoperative hardware complications were observed in any patient up to final follow-up; however, 6 cases of inferior wall fracture of the posterior arch, 2 cases of penetration of axis pedicle screws into the vertebroarterial foramen, and 2 cases of medial wall fracture of the axis pedicle were reported.
- 13 cases of burst bleeding from the C1-2 venous plexus during surgery and 9 cases of immediate pain and numbness in the occipitocervical region caused by C2 nerve roots irritation were noted in the Lateral mass group compared to no incidences in the Pedicle screw group (both p<0.01).
最も覚えておくべきことは？
In treatment of atlantoaxial instability, an operative procedure using C1 pedicle screw fixation was reported to result in a significantly shorter operation time, lower volume of blood loss, and fewer venous plexus and nerve root injuries compared to the C1 lateral mass screw fixation method. However, hospitalization time, Japanese Orthopaedic Association scores, and visual analogue scale scores were comparable between groups.
それが私の患者ケアにどのように影響するか？
The results of this study suggest that the C1 pedicle screw fixation method may be less invasive and less complicated compared to C1 lateral mass screw fixation for patients with atlantoaxial instability. Further trials with longer follow-up periods are required to evaluate the long-term effects between groups.
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