ARTHROPLASTY
No radiological and clinical advantages with patient-specific positioning guides in total knee replacement
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2018;6(11):2 Acta Orthop. 2018 Feb;89(1):89-94109 patients scheduled for total knee arthroplasty were randomized to surgery with either the use of patient-specific cutting guides or conventional intra- and extramedullary guides. Patients were assessed for overall lower limb alignment, femoral component alignment in the coronal, sagittal, and axial planes, tibial component alignment in the coronal and sagittal planes, and patient-reported outcome measures and knee range of motion over a 2-year follow-up. Results demonstrated no statistically significant differences between groups in the rate of outliers (>3deg deviation from planned alignment) in any alignment comparison, or in any patient-reported outcome measure or range of motion over a 2-year follow-up.
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。
2/4
Randomization
2/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
Therapy Description
4/5
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？
When first introduced, there was a lot of interest in patient-specific instruments as a method to potentially improve the alignment of components in total knee arthroplasty. As randomized controlled trials have been published on their use, mixed evidence in support of their efficacy has been reported. There is a continued need for high-quality studies on their use in order to determine their role in routine practice for total knee arthroplasty.
主な研究課題は何ですか？
In total knee arthroplasty, is there any significant difference in mean component alignment, the incidence of outliers in component alignment (>3deg deviation from planned alignment), or patient-reported outcome measures, over 2 years postoperatively between patient-specific instrumentation and convention instruments?
重要な知見は？
- The incidence of femoral outliers did not significantly differ between the PSI group and the CONV group in the coronal plane (7/43 vs. 4/47; p=0.3), sagittal plane (29/43 vs. 23/47; p=0.08), or axial plane (5/43 vs. 7/47; p=0.7).
- The incidence of tibial outliers did not significantly differ between the PSI group and the CONV group in the coronal plane (8/43 vs. 3/47; p=0.08) or the sagittal plane (17/43 vs. 26/47; p=0.1).
- The incidence of outliers in HKA angle (reference: neutral alignment) did not significantly differ between the PSI group and the CONV group (11/42 vs. 11/49; p=0.7).
- No significant differences between the PSI group and the CONV group were observed in KOOS scores, NRS pain scores, EQ-5D scores, or knee range of motion in flexion and extension at 3 months, 1 year, or 2 years (all p>0.05).
最も覚えておくべきことは？
In total knee arthroplasty, there were no significant differences between cases completed using patient-specific instruments and cases completed using standard intra- and extramedullary guides in rate of overall lower limb malalignment, rate of malalignment of either the femoral component or tibial component individually, or in patient-reported outcome measured and knee range of motion over 2 year follow-up.
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 there does not appear to be a clinical benefit to the use of patient-specific instruments over conventional instruments in completing total knee arthroplasties.
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