SPINE
Total disc arthroplasty does not affect the incidence of adjacent segment degeneration in cervical spine: Results of 93 patients in three prospective randomized clinical trials
This report has been verified
by one or more authors of the
original publication.
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OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(8):23 Spine Journal; 2010; 10; 1043-104893 patients, with mono or bi-level cervical disc symptomatic disease and upon failure of conservative treatment, were randomized to undergo total disc arthroplasty (TDA) or anterior cervical discectomy and fusion (ACDF). Primary Outcome Measures were Visual Analogue Score (VAS), Neck Disability Index and Radiographic Assessment were made at different time points until 48 months. Both the ACDF and TDA procedures were found to be equivalent for rendering pain relief in both mono and bi level disc disease and had equivalent risks for inducing adjacent segment degeneration. Interestingly, it was observed that patients with concurrent degenerative disc disease of the lumbar spine had greater likelihood of developing adjacent segment degeneration.
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
3/4
Outcome Measurements
1/4
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？
Anterior cervical discectomy and fusion (ACDF) is an established treatment for the degenerative disc disease of the cervical spine; however, the development of implants and procedures to restore motion, segmental anatomy, and function shows success after further investigation. The purpose of this study was to compare the incidence of adjacent segment disease in patients treated for degenerative disc disease with either total disc arthroplasty or anterior cervical discectomy and fusion.
主な研究課題は何ですか？
Is there a difference in incidence of adjacent segment disease after patients with degenerative disc disease are treated with either total disc arthroplasty or anterior cervical discectomy and fusion?
重要な知見は？
- The success rates were similar in procedures, 71% in TDA and 73.5% in ACDF, and median symptom-free survival period was 39.79+/-1.9 months for ACDF and 38.09+/- 1.9 months for TDA patients. Smokers had a trend towards worse survival rates (p=0.17) for both procedures.
- VAS and NDI scale were similar between groups (p-value = 0.693)
- No statistical difference was noted between groups in terms of development of adjacent lumbar disease (p-value = 0.885)
- Presence of documented lumbar disease was a statistically significant risk factor for development of adjacent lumbar disease (p-value = 0.016)
最も覚えておくべきことは？
Total disc arthroplasty and anterior cervical discectomy and fusion have the same clinical outcomes. However, lumbar disease increases the risk of adjacent cervical degenerative disc disease.
それが私の患者ケアにどのように影響するか？
This study suggests that both techniques are equivalent in treating degenerative disc disease and do not increase risk of adjacent lumbar disease compared to one another. The study also notes that lumbar disease is a significant risk factor for development of adjacent cervical degenerative disc disease. Therefore, it is recommended that physicians consider other factors before considering which treatment is most appropriate for patients.
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