SPINE
Comparison of the PEEK cage and an autologous cage made from the lumbar spinous process and laminae in posterior lumbar interbody fusion
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2017;5(5):14 BMC Musculoskelet Disord. 2016 Aug 30;17(1):37469 patients scheduled for single-level posterior lumbar interbody fusion were randomized to one of two different implant groups: one group received an autologous cage consisting of the resected spinous process and lamina (ACSP) from earlier in the procedure, and one group received a polyetheretherketone (PEEK) cage. The purpose of this study was to determine and compare clinical and radiographical results of the ACSP group in comparison to the PEEK cage group over 24-month follow-up. Results demonstrated no significant differences between groups in either visual analog pain scores, functional status, fusion success, restoration of disc height, or regional lordosis of the operative level.
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。
1/4
Randomization
4/4
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？
Posterior lumbar interbody fusion is a standard procedure performed in the treatment of patients with degenerative lumbar disc disease. Synthetic fusion cages made of polyetheretherketone (PEEK) are often used to complete these procedures. While generally accepted as providing patients with excellent outcomes, PEEK cages, as a result of their synthetic nature, can result in long-term complications and need for removal. An autologous graft composed from en bloc resection of the spinous process and laminae during surgery has been suggested as a possible alternative, although data on the efficacy of this graft material is limited.
主な研究課題は何ですか？
In posterior lumbar interbody fusion, is there any significant difference between an autologous cage made from the lumbar spinal process and lamina and a standard, synthetic polyetheretherketone (PEEK) cage in clinical and radiological results over 24-month follow-up?
重要な知見は？
- VAS pain scores improved significantly from preoperative to postoperative within both the ACSP group (7.54+/-1.24 to 2.05+/-0.61) and the PEEK group (7.23+/-0.88 to 1.86+/-0.63); the difference between groups in postoperative VAS pain score was not statistically significant (p>0.05).
- An "Excellent" or "Good" functional rating was given to thirty patients of each group; the remaining patients in each group were rated as "Fair". No patient of either group was rated as having a "Poor" functional outcome.
- Successful fusion within 8-12 weeks of surgery was documented in >90% of patients in both groups, and 100% of patients by 24 months.
- Disc height increased preoperatively to postoperatively in the ACSP group from 21.50+/-4.77mm to 43.29+/-3.62mm, and in the PEEK group from 21.91+/-3.75mm to 45.43+/-3.51mm; the difference between groups in postoperative disc height was not statistically significant.
- No significant differences between groups were observed in regional lordosis of PLIFs at either L3/4, L4/5, or L5/S1 (all p>0.05).
- One superficial wound infection occurred in the PEEK group. No cases of surgery-related neurological injury or hardware failure were documented in either group.
最も覚えておくべきことは？
In instrumented single-level posterior lumbar interbody fusion, cases completed with an autologous cage using the resected spinal process and lamina during the procedure demonstrated similar clinical and radiological results to those completed with a polyetheretherketone (PEEK) cage.
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 an autologous cage using the resected spinal process and lamina in posterior lumbar interbody fusion may offer an effective alternative to standard PEEK cages in these procedures. While the body of evidence on the use of the autologous cage used in the current study is still limited, if consistent efficacy is demonstrated in subsequent studies, it could represent a more inexpensive alternative to synthetic PEEK cages.
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