SPINE
Transforaminal lumbar interbody fusion (TLIF) versus posterolateral instrumented fusion (PLF) in degenerative lumbar disorders: a randomized clinical trial with 2-year follow-up
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OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(19):36 Eur Spine J. 2013 Sep;22(9):2022-9100 patients suffering from degenerative lumbar disorders were randomized to evaluate the efficacy of transforaminal lumbar interbody fusion (TLIF) against instrumented posterolateral fusion (PLF), over 2 years. Functional outcome, patient satisfaction, complication rates, and operative factors were each evaluated. The TLIF procedure was associated with a significantly greater operation time and increased blood loss, as well as displaying a trend towards more leg pain, when compared against the PLF group.
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
Randomização
3/4
Medidas de resultado
3/4
Inclusão/Exclusão
4/4
Descrição do tratamento
4/4
Estatística
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？
Spinal fusion is a commonly used treatment for patients with low back pain caused by degeneration, failed disc surgery, spondylosis, spondylolisthesis, as well as resistance to conservative treatment. However, there is conflicting evidence on whether the use of transforaminal lumbar interbody fusion (TLIF) results in a lower morbidity rate compared to posterolateral lumbar fusion (PLF) and if it is as effective as the conventional method of treatment. This study was therefore needed to evaluate the efficacy of TLIF against PLF for functional outcome in patients with degenerative lumbar disorders.
主な研究課題は何ですか？
Does transforaminal lumbar interbody fusion (TLIF) provide more effective results in treatment for degenerative lumbar disorders than posterolateral lumbar fusion (PLF) in terms of functional disability, pain, fusion rate, and complications, when assessed over a span of 2 years?
重要な知見は？
- Operation time (288 min in TLIF versus 171 min in the PLF; p< 0.001) and blood loss (775ml in the TLIF versus 443ml in the PLF; p= 0.001) were significantly higher in the TLIF group, but length of hospital stay remained comparable between groups (9.8 versus 9.3; p= 0.405)
- Both the TLIF and PLF groups significantly improved compared to baseline evaluations in terms of DPQ and the LBPRS, (both p< 0.05), but no significant differences between groups was apparent for any of the other outcome parameters measured at any time point (each p> 0.05)
- TLIF group patients demonstrated a trend towards developing more leg pain compared to the PLF group (p> 0.05), but was deemed insignificant; a subgroup analysis on diagnosis did not distinguish any substantial benefits associated with TLIF procedures (p> 0.05 for each)
- Fusion rate at 2 years was 94% in the TLIF compared against 88% in the PLF group (p= 0.31); 16 TLIF patients used opioids and 3 TLIF patients used antidepressants compared to 14 and 6 at 2 years in the PLF group (p> 0.05).
- Complication rate in the TLIF group was 14% (7 patients) compared against 6% (3 patients) in the PLF group (p= 0.205)
- 33 of 46 (72%) TLIF patients and 33 of 45 (73%) PLF (p= 0.87) rated overall satisfaction positively at 2 years
- Work status comparisons at 2 years after surgery between groups was insignificant (p= 0.6) with 23 patients working, 1 without work, 2 on sick leave, and 22 retired in the TLIF group, compared against 23 working, 2 on sick leave, and 27 retired in the PLF group
最も覚えておくべきことは？
Transforaminal interbody fusion and instrumented posterolateral fusion provided similarly effective functional outcomes for lower back pain, when compared against baseline. However, the transforaminal interbody fusion group was found to have a significantly greater operation time and blood loss compared to the posterolateral fusion group. A trend towards more leg pain in the transforaminal interbody fusion group was also observed, but this was deemed insignificant.
それが私の患者ケアにどのように影響するか？
Transforaminal interbody fusion and instrumented posterolateral fusion in treatment for degenerative provided equally effective results in terms of the Dallas Pain Questionnaire (DPQ) and the pain index from the low back pain rating scale (LBPRS).The transforaminal interbody fusion group patients was also observed to have a significantly greater operation time and blood loss compared to the posterolateral fusion group. Further studies are needed to evaluate the validity of the findings presented in this study.
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