ARTHROPLASTY
Component alignment during total knee arthroplasty with use of standard or custom instrumentation: a randomized clinical trial using computed tomography for postoperative alignment measurement
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OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2014;2(11):8 J Bone Joint Surg Am. 2014 Mar 5;96(5):366-7263 male patients (64 knees) undergoing total knee arthroplasty (TKA) were randomized to receive treatment using either patient-specific cutting blocks - derived from 3D preoperative CT images - or standard instrumentation. The purpose of this study was to compare these two approaches with respect to component alignment and short-term clinical outcomes. Results at 6 months indicated that there were no significant differences between groups in regards to clinical outcomes or tibial and femoral component alignment. The number of outliers with respect to sagittal tibial alignment/slope was significantly greater when patient-specific guides were used.
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
Randomização
3/4
Medidas de resultado
3/4
Inclusão/Exclusão
4/4
Descrição do tratamento
3/4
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？
A current trend in total knee arthroplasty (TKA) research is the use of patient-specific cutting blocks for improving the alignment of components. In order to customize these guides, patients undergo either magnetic resonance imaging (MRI) or computer tomography (CT) scans preoperatively to produce an image of their knee, from which these individualized cutting blocks are made. The majority of studies looking at this technique have used two-dimensional radiographs as opposed to 3D CT data. This study was needed to compare clinical outcomes and component alignment in patients undergoing TKA with either patient-specific cutting blocks (from 3D CT imaging) or standard instrumentation.
主な研究課題は何ですか？
In TKA, how does the use of patient-specific cutting blocks (derived from 3D preoperative CT images) compare to standard instrumentation (i.e. intramedullary femoral and external tibial cutting guides), with respect to clinical outcomes and component alignment, when assessed at 6 months?
重要な知見は？
- Between the study and control groups, respectively, there was no significant difference in surgical time (88.1 vs 92.1 minutes), postoperative hematocrit (31.9% vs 32.2%), hospital stay (3.1 vs 3.0 days), Knee Society rating scores (86.4 vs 90.2), Knee Society function scores (73.2 vs 82.1), improvement in KSS from baseline (+31.4 vs +31.1), or flexion arc (102.1 vs 104.1 degrees) (all p>0.05).
- Although one patient who underwent bilateral knee arthroplasty required two autologous units of blood, no patient in either group required a postoperative allogenic transfusion.
- There were no significant differences between the study and control groups with respect to the coronal mechanical axis (1.7 vs 1.3 degrees varus), the coronal femoral alignment (1.1 vs 1.0 degrees varus), femoral rotation (0.8 vs 1.7 degrees internal rotation), coronal tibial alignment (0.7 vs 0.3 degrees of varus), or sagittal tibial aslope (1.5 vs 2.4 degrees posterior) (all p>0.05).
- Although there were no significant differences between the study and control groups with respect to the percentage of outliers for the coronal mechanical axis (41% vs 38%), coronal femoral alignment (23% vs 23%), femoral rotation (27% vs 46%) and the coronal tibial alignment (14% vs 4%) (all p>0.05), there were significantly more outliers in the study group in regards to sagittal tibial alignment/slope (32% vs 8%; p=0.032).
- In the study group, the use of patient-specific guides was abandoned in 7/22 knees (32%). Insufficient extension space was noted in 12/22 knees (55%) of the study group, warranting additional cutting of either the femoral bone, the tibial bone, or both. Modifications to component size from preoperative plans in the study group occurred in 9/22 (41%) knees.
- In the control group, more bone was resected, following the initial cut, from either the distal femur or proximal tibia in 6 knees (23%) due to insufficient extension space. For one patient in this group, an excessive amount of bone was resected, requiring a polyethylene insert and a different, more constrained, implant.
- One patient in the control group required re-operation at 3 weeks, and another in the same group was scheduled to undergo revision for implant loosening at the time of publication.
最も覚えておくべきことは？
In total knee arthroplasty, patient-specific guides were not associated with significant differences in surgical time, postoperative hematocrit, hospital stay, Knee Society Scores, range of motion, as well as tibial or femoral component alignment as compared with standard instrumentation. More cases where patient-specific guides were used had outliers in tibial slope.
それが私の患者ケアにどのように影響するか？
The results from this study suggest that the use of patient-specific cutting blocks from preoperative 3D CT scans do not improve femoral and tibial component alignment, and malalignment in tibial slope was more frequently observed with their use. This is an important finding since preoperative CT scans are costly and create a delay before surgery can be performed. As a result, further evaluation of efficacy is warranted, and future studies should include a cost-effectiveness analysis comparing patient-specific guides and conventional instrumentation.
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