NSAID Use and Healing After Tibia Fractures and Achilles Tendon Ruptures
试验速览
- 阶段
- 不适用
- 入组人数
- 456
- 主要终点
- Incidence of non-union after tibia fracture
研究概览
简要总结
Rationale: The Emergency Department (ED) typically serves as the front line for patients with acute fractures and tendon ruptures. Pain control for these patients is an essential task of the ED physician. With the advent of the opioid epidemic, ED physicians are becoming more inclined to prescribe non-narcotic pain medications such as non-steroidal anti-inflammatory drugs (NSAIDs). Yet, the effects of NSAIDs on musculoskeletal healing are controversial. The few human studies examining the effects of NSAID use on fracture healing have provided conflicting results. Even less is known about the effects of NSAIDs on tendon healing as this information has largely been gleaned from rodent studies with contradictory findings. There has never been a large, prospective, randomized, double-blinded study to determine the effects of NSAIDs on healing after fractures or tendon ruptures. Here, I propose to pilot the first prospective, randomized, double-blinded study examining the effects of NSAID use on healing after tibia fractures and Achilles tendon ruptures.
Aim 1 seeks to determine whether NSAID use is associated with an increased incidence of fracture nonunion and worse functional recovery six months following tibia fractures. I hypothesize that NSAID use after tibia fractures will be associated with an increased incidence of fracture nonunion and worse functional recovery. Aim 2 seeks to determine whether NSAID use is associated with worse functional recovery six months after Achilles tendon ruptures. I hypothesize that NSAID use after Achilles tendon ruptures will be associated with worse functional recovery.
Significance: Emergency Department providers commonly prescribe NSAIDs for pain control following fractures and tendon injuries. However, the implications of this practice on bone and tendon healing are unknown. This proposal will pilot the first prospective, randomized, double-blinded study to determine whether NSAID use affects healing after tibia fractures and Achilles tendon ruptures. Results from this study will impact NSAID prescribing patterns for tibia fractures and Achilles tendon ruptures in the ED, either by demonstrating that they impair recovery and should be avoided, or that they need not be withheld as an effective non-narcotic form of pain control.
详细描述
Specific Aims The Emergency Department (ED) typically serves as the front line for patients with fractures and tendon ruptures. Pain control for these patients is an essential task of the ED physician. With the advent of the opioid epidemic, ED physicians are becoming more inclined to prescribe non-narcotic pain medications such as non-steroidal anti-inflammatory drugs (NSAIDs). Yet, the effects of NSAIDs on musculoskeletal healing are highly controversial. There is some evidence that NSAIDs may prevent osteoblasts from rebuilding bone after fractures by inhibiting COX-2. Indeed, some retrospective studies have found NSAID use to be associated with an increased incidence of fracture nonunion after acetabular, tibial, and humeral shaft fractures, while other studies reported no difference. The only prospective randomized controlled trials evaluating the effects of NSAIDs on fracture healing reported no effect of NSAID use on healing after Colles fractures; however, these trials were likely underpowered to detect a difference in nonunion rates. Here, I propose to pilot the first large, prospective, randomized, double-blinded study examining the effects of NSAIDs on healing after tibia fractures, which are vulnerable to nonunion.
Similar to fractures, the effects of NSAIDs on tendon healing are unclear. Some studies suggest that NSAIDs may inhibit proliferation and migration of tendon cells after injury, while other studies indicate that NSAIDs enhance collagen synthesis. Rodent studies are equally conflicting, with some reports of worse outcomes associated with NSAID use and other studies showing no difference. Recently, I obtained preliminary data showing that NSAID use after Achilles tendon ruptures is associated with worse functional outcomes as measured by the Achilles Tendon Total Rupture Score (ATRS). While this was the first study examining the effects of NSAID use on recovery after Achilles tendon rupture in humans, the data were retrospective, observational, and not blinded. Here, I propose to pilot the first prospective, randomized, double-blinded study to determine the effects of NSAIDs on recovery after Achilles tendon ruptures.
Aim 1: Determine whether NSAID use is associated with an increased incidence of fracture nonunion and worse functional recovery six months after tibia fractures.
Hypothesis: I hypothesize that NSAID use after tibia fractures will be associated with an increased incidence of fracture nonunion and worse functional recovery.
Aim 2: Determine whether NSAID use is associated with worse functional recovery six months after Achilles tendon ruptures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Acetaminophen
Patients will receive 650mg PO Acetaminophen every 6 hours as needed for pain
干预措施: Acetaminophen (Drug)
Ibuprofen
Patients will receive 600mg PO Ibuprofen every 6 hours as needed for pain
干预措施: Ibuprofen 600 mg (Drug)
结局指标
主要结局
Incidence of non-union after tibia fracture
时间窗: 6 months
Fractures
Functional Recovery after Achilles Tendon Rupture
时间窗: 6 months
Achilles Tendon Total Rupture Score measures functional recovery after Achilles tendon rupture on a scale of 0 (worse) to 100 (best).
次要结局
- Functional Impairment after Tibia Fracture on a scale of 1 to 3 (none to severe)(6 months)
- Degree of pain after Tibia Fracture on a scale of 1-9(6 months)
研究者
Vanessa Franco, MD, PhD
Assistant Professor
University of California, Los Angeles