Single bisphosphonate infusion does not speed up fracture healing in high tibial osteotomy .
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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)?
Sim = 1
Incerto = 0,5
Não relevante = 0
Não = 0
A Avaliação dos Critérios de Relato avalia a transparência com que os autores relatam as caraterísticas metodológicas e do ensaio na publicação. A avaliação está dividida em cinco categorias que são apresentadas de seguida.
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
O Índice de Fragilidade é uma ferramenta que auxilia na interpretação de achados significativos, fornecendo uma medida de força para um resultado. O Índice de Fragilidade representa o número de eventos consecutivos que precisam de ser adicionados a um resultado dicotómico para que o resultado deixe de ser significativo. Um número pequeno representa um resultado mais fraco e um número grande representa um resultado mais forte.
Porque é que este estudo era necessário agora?
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.
Qual era a principal questão de investigação?
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?
- 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.
De que é que me devo lembrar mais?
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.
Como é que isto afectará o tratamento dos meus doentes?
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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