ARTHROPLASTY
Do patients care about higher flexion in total knee arthroplasty? A randomized, controlled, double-blinded trial
This report has been verified
by one or more authors of the
original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(8):8 BMC Musculoskelet Disord. 2013 Apr 8;14(1):127. doi: 10.1186/1471-2474-14-12736 patients undergoing a one-stage bilateral total knee arthroplasty were randomized to receive standard cruciate-retaining (CR) TKA in one knee and high-flex posterior-stabilized (PS) TKA in the other. This trial was designed to investigate whether higher flexion had an effect on patient perceived outcomes. 1 year results through Visual Analogue Scale and Short Form-36 survey indicated no differences in ability to perform daily activities, satisfaction, “feel” of the knee, or pain in either prosthesis.
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
3/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
Therapy Description
4/4
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？
In total knee arthroplasty, range of motion is considered to be a measurement of functional success. New high flex prosthetic designs have been used, but studies have not been able to show that increased flexion beyond 110 degrees have an influence on patient-perceived outcomes. This trial, therefore, aimed to investigate whether insertion of high flex posterior stabilized TKA had increased patient satisfaction, reduced pain, better “feel” and better abilities in activities of daily living compared to standard cruciate retaining prosthesis.
主な研究課題は何ですか？
Does higher knee flexion, provided by high-flex PS-TKA, affect patient-perceived outcomes, such as pain, satisfaction, ability to perform daily tasks, and "feel" of the knee at 1 year, compared to standard CS-TKA?
重要な知見は？
- PS TKA and CR TKA had similar mean maximum active and passive flexion preoperatively, at week 6 and 3 months. However, at 6 months and 1 year, PS TKA had significantly better flexion (p<0.05). By final follow up, 30 of the CR TKA’s and 31 of the high-flex PS TKA’s were able to extend to 0–5 degrees (P>0.05)
- VAS knee pain was similar in both types of TKA at all-time points (P>0.05).
- VAS satisfaction did not differ between PS TKA and CR TKA at all-time points (P>0.05)
- Patient perceived “feel” of the knee was reported to be the same at all-time points between the knees (P>0.05)
- Satisfaction in ROM during activities of daily living, biking, squatting, facing barriers, were stated to be similar in both prosthesis (P>0.05)
- For SF-36, 26/33 patients who completed questionnaire had comparable median physical component score (PCS) of 47.8 (range: 20.6-57.9) and median mental component score (MCS) of 59.2 (range: 32.8-64.6)
最も覚えておくべきことは？
Although high flexion PS prosthesis significantly increased flexion at 12 months compared to standard CR prosthesis, it had no significant effect on patient-perceived results, such as pain, satisfaction, "feel" of the knee, and ability to perform daily activities.
それが私の患者ケアにどのように影響するか？
The findings suggest that increasing flexion beyond 110 degrees through high-flex PS prosthesis does not produce better patient related outcomes in this population. Further studies with larger sample sizes should be conducted to suggest the best prosthesis choice across different populations and activity levels.
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