ARTHROPLASTY
Unicompartmental or total knee replacement: The 15-year results of a prospective randomized controlled trial
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(4):6 J Bone Joint Surg Br. 2009 Jan;91(1):52-7To compare the two surgical procedures, 102 knees requiring knee replacement were randomized to receive either unicompartmental knee replacement (UKR) or total knee replacement (TKR). A previous assessment established that UKR had superior results at 5 year follow-up. The continued 15 year follow-up demonstrated that results were maintained with 71.4% of patients having excellent outcomes in terms of Bristol knee score and prosthesis survivorship.
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
3/4
Outcome Measurements
3/4
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？
Unicompartmental knee replacement (UKR) has increased in popularity over the last few years; however, there is still an existent belief that a TKR is preferable for patients over the age of 60, as is regarded to have a better success rate. The data in this study has previously established the superiority of UKR with a follow up of 5 years. For a longer term follow up of 15 years, this study was conducted to validate the findings.
主な研究課題は何ですか？
Does the use of the St Georg Sled unicompartmental knee replacement provide superior outcomes when compared to total knee replacement at 15 years?
重要な知見は？
- Surgeries in 4 patients in the UKR group were unsuccessful (either revision surgery or a Bristol knee score < 60), whereas in 6 patients in the TKR group were considered unsuccessful (p=0.51) .
- 71.4% of patients had an excellent outcome in the UKR group compared to 52.6 % in the TKR.
- Average Bristol knee scores were 92 and 87.5 in the UKR and TKR groups, respectively (p=0.99), with the median pain scores being 40 and 35 (15-90), respectively.
- The survivorship of the implant (either revision surgery or a Bristol knee score < 60) was 89.8% (95% CI 74.3 to 100) in the UKR group and 78.7% (95% Ci 56.2 to 100) in the TKR group. There was no difference in survival between the two groups (p=0.51).
- 78% patients in the UKR group had > 120° of flexion compared to 38% in the TKR group (p=0.08).
最も覚えておくべきことは？
Unicompartmental knee replacement maintained the excellent early results at 15 years, demonstrating excellent Bristol knee scores and implant survivorship.
それが私の患者ケアにどのように影響するか？
The use of UKR can provide excellent results for elderly patients requiring knee replacement. Further research is needed with larger simple sizes.
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