OSTEOARTHRITIS
A single bisphosphonate infusion does not accelerate fracture healing in high tibial osteotomies
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OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(11):170 Acta Orthop. 2011 Aug;82(4):465-70. Epub 2011 Jun 2146 patients with knee osteoarthritis undergoing high tibial osteotomies were randomized 4 weeks postoperatively to receive a single bisphosphonate infusion of zoledronic acid or a sodium chloride placebo. The primary outcome was reduction in healing time. Other outcomes included hip knee ankle (HKA) angle and patient-relevant outcome measures (Knee injury and osteoarthritis outcomes score (KOOS)). Results indicated that a single bisphosphonate infusion intervention does not accelerate healing in high tibial osteotomies.
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
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？
Strength of a healing fracture has been known to increase with the use of anti-catabolic drugs, such as bisphosphonates. A human pilot study examined high tibial osteotomies in knee osteoarthritis, which indicated healing time was shortened with the use of bisphosphonates. The current study examines the effect of a bisphosphonate (zoledronic acid) infusion on reducing healing time after high tibial osteotomies.
主な研究課題は何ですか？
What are the outcomes in rate of fracture healing, hip-knee-ankle (HKA) angle, and patient-relevant outcome measures when a single bisphosphonate (zoledronic acid) infusion is intravenously administered, compared to a sodium chloride placebo in patients with knee osteoarthritis after undergoing a high tibial osteotomy?
重要な知見は？
- All osteotomies healed in both the zoledronic acid (intervention) and sodium chloride (control) groups.
- No difference was seen in the rate of healing between the intervention and control group. Zoledronic group: 77 days (95% CI: 75-80); Sodium chloride group: 77 days (95%CI: 74-81). However, pin fixation of the external frame increased with the intervention of a single zoledronic acid infusion.
- The DEXA analysis indicated similar outcomes in bone mineral density and bone mineral content between the two groups.
- Both groups showed an improvement in KOOS scores. Small but non-statistically significant differences were seen between the groups.
- For the hip, knee, ankle (HKA) angles, no change was seen between the two groups. The zoledronic group had a mean change of 0.3 (SD 3.3) degrees compared to -1.0 (SD 3.3) degrees in the control group (p=0.2)
- 13/25 patients from the zoledronic group reported muscle pain and influenza-like symptoms compared to 2/21 patients from the placebo group (RR=5, CI: 1.3-20; p=0.004).
- According to the radiographic results, both the intervention and control group retained correction when examined at the 1.5-year follow-up.
最も覚えておくべきことは？
The single zoledronic acid (bisphosphonate) infusion intervention did not accelerate healing in high tibial osteotomies when compared to the sodium chloride placebo. However, there was an increase in pin fixation of the external frame in the zoledronic acid group.
それが私の患者ケアにどのように影響するか？
The use of a single dose of zoledronic acid after undergoing a knee osteotomy does not appear to provide patients with an increased rate of fracture healing. Further examination is required to identify if single dose zoledronic acid treatment provides improved healing rates or superior bone mineral density for different orthopaedic procedures.
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