*Department of Orthopaedic Surgery, Louisiana State University Medical Center, New Orleans, LA; †Department of Statistics, North Carolina State University, Raleigh, NC; ‡Department of Orthopaedic Surgery, Duke University, Durham, NC; and §Department of Orthopaedic Surgery, University of Pennsylvania, Philadelphia, PA.
J Orthop Trauma. 2017 May;31(5):248-251. doi: 10.1097/BOT.0000000000000778.
The clinical value of low-intensity pulsed ultrasound (LIPUS) for fresh fracture is known. Yet, in the absence of a definition of what "fresh" is, payers have adopted study inclusion criteria drawn from randomized clinical trials as de facto definitions of which patients should be treated, with "fresh" defined as <1 week old. Patients with fracture may thus be ineligible for LIPUS treatment after week 1, which potentially denies access to patients who could benefit from LIPUS. We seek to characterize the inflection point at which heal rate declines.
Prospective cohort.
Food and Drug Administration-mandated nationwide postmarketing surveillance registry.
Observational cohort of 5983 registry enrollees.
LIPUS, 20 min/d.
Fracture heal rate. Logistic regression was used to model the odds ratio of nonunion from week 1 to week 12. Covariates in the model included age, gender, body mass index, open fracture, and smoking.
We estimated the time point at which a fracture responds to LIPUS as well as during the first week after fracture. There was significant bone-to-bone variation; metatarsal was "fresh" until week 7, ankle until week 9, humerus until week 10, and femur and radius until week 12. Healing was significantly impacted by patient age, body mass index, and open fracture (all, P ≤ 0.02).
Our results suggest that fractures of the metatarsal, femur, humerus, ankle, and radius respond to LIPUS treatment, as if they were still fresh at least 6 weeks longer than the eligibility allowed under current coverage policies.
Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.
低强度脉冲超声波（LIPUS）在新鲜骨折中的临床价值是已知的。然而，由于缺乏对“新鲜”的定义，支付者采用了随机临床试验的纳入标准作为事实上的定义，即哪些患者应该接受治疗，将“新鲜”定义为<1 周。骨折患者可能因此在第 1 周后没有资格接受 LIPUS 治疗，这可能使那些可能受益于 LIPUS 的患者无法获得治疗。我们试图确定愈合率下降的拐点。
前瞻性队列研究。
食品和药物管理局要求的全国性上市后监测登记处。
登记处的 5983 名观察队列患者。
LIPUS，20 分钟/天。
骨折愈合率。使用逻辑回归模型来模拟从第 1 周到第 12 周的骨折不愈合的比值比。模型中的协变量包括年龄、性别、体重指数、开放性骨折和吸烟。
我们估计了骨折对 LIPUS 反应的时间点以及骨折后第一周的时间点。存在显著的骨对骨差异；跖骨直到第 7 周才“新鲜”，踝关节直到第 9 周，肱骨直到第 10 周，股骨和桡骨直到第 12 周。患者年龄、体重指数和开放性骨折对愈合有显著影响（均 P≤0.02）。
我们的结果表明，跖骨、股骨、肱骨、踝关节和桡骨的骨折对 LIPUS 治疗有反应，就好像它们至少在当前覆盖政策允许的资格期限之外仍然“新鲜”至少 6 周。
治疗性 III 级。请参阅作者说明以获取完整的证据水平描述。
