ARTHROPLASTY
Rotation in total knee arthroplasty: no difference between patient-specific and conventional instrumentation
This report has been verified
by one or more authors of the
original publication.
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これにより、臨床的に意義のある研究をより早く認識することが可能になり、読者は将来の診療を形成する可能性が最も高い論文に集中することができます。
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2014;2(1):6 Knee Surg Sports Traumatol Arthrosc. 2013 Oct;21(10):2213-940 patients, between the ages of 50 and 85, who were unresponsive to conservative treatment and were scheduled to receive total knee arthroplasty (TKA), were randomly assigned into 1 of 2 groups to test the effect of patient-specific instrumentation (PSI) on accuracy and rotational alignment in TKA. Patients received treatment with PSI or through a conventional TKA. Results indicated that PSI did not have a significant effect on the rotational alignment in patients following TKA.
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
4/4
Outcome Measurements
2/4
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？
Implant malposition has been reported to be as high as 20-40% when using conventional instrumentation in total knee arthroplasty. To reduce the likelihood of implant malposition patient-specific instrumentation (PSI) was introduced with the goal of improving implant positioning and reducing the overall cost and surgery time needed to complete the procedure. Previous studies have shown that PSI can successfully restore the mechanical axis, but very little information has been gathered regarding the role of PSI in the rotation of the tibial and femoral implants. This study was brought forward to assess the matching of preoperative planning and postoperative position of the TKA implants, and to closely analyze the femoral rotation of implants positioned with or without PSI.
主な研究課題は何ですか？
Does the use of patient-specific instruments improve the accuracy of the rotational alignment in TKA?
重要な知見は？
- Patients in the PSI group experienced <2 degrees or mm of difference between the planned position of the femoral implant and the obtained position in all femoral measurements except distal cut flexion angle (Mean difference of 2.6 degrees, 95% CI= 0.9)
- Patients in the PSI group experienced <2 degrees of difference between the planned position of the tibial implant and the obtained position when analyzing average tibial proximal cut (1.2 degrees), but not when looking at mean tibial slope angle (Mean difference of 2.2 degrees, 95% CI= 0.8), and tibial rotation (Mean difference of 6.8 degrees, 95% CI= 2.1).
- A total of 90% of all patients in the PSI group experienced less than 2 degrees or less than 2 mm of difference between the planned position of the femoral and tibial implants and their obtained positions, expect for when measuring tibial rotation, where the variations were much higher.
- No difference was observed between the two groups when analyzing weight-bearing full length X-rays 3 months after surgery. Mean HKA was 179 degrees in the PSI group with 4 outliers compared to 178.3 degrees with 2 outliers in the control group (p>0.05).
- No difference was found between the two groups concerning frontal and sagittal position of implants measured through Ml and AP X-rays (FFC, FTC, LFC, and LTC angle, and tibial slope, p>0.05 for all measurements).
- No significant difference in femoral rotation was observed between the two groups with a mean of 0.4 degrees begin expressed in the PSI group compared to 0.2 degrees in the control group (p>0.05).
- Mean tibial rotation was 8 degrees of internal rotation in the PSI group compared to 15 degrees of internal rotation in the control (p>0.05).
最も覚えておくべきことは？
90% of all patients in the PSI group experienced less than 2 degrees or less than 2 mm of difference between the planned position of the femoral and tibial implants and their obtained positions, expect for when measuring tibial rotation, where the variations were much higher. No difference was observed between the two groups when analyzing weight-bearing full length X-rays 3 months after surgery or when concerning frontal and sagittal position of implants measured through Ml and AP X-rays. No difference in femoral rotation was found between the groups. Average tibial rotation was also similar between the two groups.
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 indicate that PSI does not improve rotation/ rotational alignment in TKA. Further research must be completed on the topic of patient-specific instrumentation to fully understand the effect it has on outcomes following TKA.
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