ARTHROPLASTY
Lower periprosthetic bone loss and good fixation of an ultra-short stem compared to a conventional stem in uncemented total hip arthroplasty
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2016;4(8):4 Acta Orthop. 2015 Dec;86(6):659-6651 patients with osteoarthritis undergoing total hip arthroplasty were randomized to receive either an uncemented conventional tapered stem or an uncemented ultra-short stem. The purpose of this randomized controlled trial was to compare the different stems in terms of periprosthetic bone loss in the proximal femur, safety, and migration, at 2 years postoperatively. The results suggested that the decrease in periprosthetic bone mineral density (Gruen zone 1 and 1-7) was significantly lower in the ultra-short stem patients. During the first 6 postoperative weeks, the ultra-short stem group displayed greater implant migration, which remained significant at 2 years. Between groups, clinical outcomes were similarly improved at 2 years and adverse events were comparable.
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。
4/4
Randomization
2/4
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？
Total hip arthroplasty (THA) is a common procedure in patients with hip osteoarthritis, and there are various prosthetic designs and techniques utilized to minimize the risk of complications and revisions while maintaining excellent patient outcomes. Periprosthetic bone loss in uncemented femoral stems raises concerns of fracture, and shorter femoral stems have gained popularity as they aim to provide a more physiological load pattern in the femur and reduce stress shielding. The absence of a stem that engages the diaphysis of the femur prevents off-loading of the proximal femur, but may also affect the stability necessary for bone integration of the implant. The present study sought to analyze the effects of an ultra-short uncemented stem in patients with osteoarthritis undergoing THA.
主な研究課題は何ですか？
In patients undergoing total hip arthroplasty for the treatment of osteoarthritis, how did an ultra-short uncemented stem compare to a conventional tapered uncemented stem in terms of periprosthetic bone loss in the proximal femur, safety, and achievement of fixation at 2 years postoperatively?
重要な知見は？
- At 2 years, the decrease in BMD in zone 1 was significantly smaller in the ultra-short stem group compared to the conventional group (MD: 18.2% [95% CI 9.5, 26.8]; p<0.001). In zone 7, the decrease in BMD did not significantly differ between groups (MD: 4.5% [95% CI 2.8, 11.8]; p=0.4).
- At 2 years, the decrease in BMD in the entire periprosthetic region (Zone 1-7), was significantly less in the ultra-short stem group (MD: 5.3% [95% CI 1.5, 9.1]; p=0.02).
- After 6 weeks postoperative, the ultra-short stems demonstrated significantly median maximum total point motion (1.51mm [0.33-5.44]) compared to the conventional stem group (0.74mm [0.13-5.29]), and significance was maintained up to 2 year follow-up (1.71mm [0.39-6.00] vs. 0.87 [0.87-7.47], respectively; p=0.01). Migration had stopped after 3 months for the majority of components in both groups, and all components were stable at 2 years.
- Both groups displayed significant improvements from baseline to 2 years postoperatively in the median HHS and WOMAC scores. However, no significant differences were noted in these outcomes between groups (p=0.2 and p=0.5, respectively)
- The improvement in health-related quality of life (EQ-5D) was similar between groups at 2 years. The number of patients suffering from mid-thigh pain was greater in the conventional group during the first 6 months, without reaching statistical significance at any point.
- Adverse events were similar between groups (Ultra-short: 45 vs. Conventional: 51). Periprosthetic fracture occurred in one patient in the Ultra-short stem group and periprosthetic infection occurred in one patient in the conventional stem group
最も覚えておくべきことは？
At 2 years, the decrease in periprosthetic bone mineral density in the proximal femur at Gruen zone 1 was significantly lower in the total hip arthroplasty patients who received an uncemented ultra-short stem when compared to a conventional tapered uncemented stem. During the first 6 postoperative weeks, the ultra-short stem group displayed significantly more migration when compared to conventional stems, this difference lasted to the 2 year follow-up. Between groups, all clinical outcomes (HHS, WOMAC, EQ-5D, mid-thigh pain) were similarly improved at 2 years, and adverse events were comparable.
それが私の患者ケアにどのように影響するか？
The results of this randomized controlled trial suggest that at 2 years, the use of an uncemented ultra-short stem may reduce periprosthetic bone loss in the greater trochanteric region and along the entire preriprosthetic region, though was associated with greater migration early in the follow-up period compared to a conventional stem. Nevertheless, clinical outcome and adverse events did not appear to be affected within this time frame. Further study is warranted given the small evidence base of high-quality literature on the topic, and limited results regarding long-term stability and survivorship between the two designs.
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