Impact of Surgery on Pain in Lateral Compression Type Pelvic Fractures: a Prospective Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Posttreatment Pain
研究概览
简要总结
Lateral compression type pelvic ring injuries remain the most common type of pelvic fractures encountered. There is a substantial amount of controversy surrounding the treatment of these injuries and there is evidence that both operative and non-operative treatment can be successful.
详细描述
The crux of the problem is determining which of these patients would benefit from early surgical stabilization and which will heal uneventfully without surgery. Many authors site patient pain and inability to mobilize as indications for surgery, although there is conflicting evidence supporting this claim. The presence of chronic pain in the trauma population is a growing area of interest, and there is a push towards controlling pain more effectively in the acute setting. It remains to be proven that surgical intervention is more effective at decreasing acute and longer term pain.
There is evidence in the literature to support both operative and non-operative treatment of patients with LC1 or LC2 pelvic fractures. There is conflicting evidence that surgical stabilization decreases acute pain and narcotic requirements, although patients are often counseled to that effect. The investigators propose to prospectively randomize patients with lateral compression type pelvic fractures to non-operative versus operative treatment and track which group has less pain, less need for narcotic pain medications, and who mobilizes with physical therapy faster.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has one of the following pelvic fractures (includes bilateral sacral fractures): Lateral compression type 1, Lateral compression type 2, Lateral compression type 3
- •The patient is between 18 and 80 years of age, inclusive
- •The patient has reached skeletal maturity
- •The patient's pelvic fracture is a result of trauma (includes polytraumatized patients)
- •The patient/family/guardian is English-speaking
- •The patient's surgeon agrees to randomization (the patient is amendable to either operative or non-operative treatment)
- •Patient enrollment and, if applicable, patient randomization can occur within 96 hours post injury
排除标准
- •The patient has prior surgical hardware in place that precludes intervention
- •The patient's pelvic fracture is classified as a Lateral compression type 1 and the associated sacral fracture is incomplete as indicated by failure to violate both the anterior and posterior cortex
- •The patient received prior surgical intervention for his/her current pelvic injury
- •The patient has sacral morphology that precludes percutaneous fixation
- •The patient is non-ambulatory due to an associated spinal cord injury
- •The patient was non-ambulatory pre-injury
- •The patient is currently pregnant
- •The patient is enrolled in another research study that does not allow co-enrollment
- •The patient is likely to have severe problems with maintaining follow-up
研究组 & 干预措施
Operative
Patients enrolled in the operative treatment group will undergo surgical intervention for their pelvic fracture. The surgeon will decide the best surgical technique as per standard of care for the patient's injury. The patient will mobilize as per the surgeon's instructions and x-rays will be taken at follow-up clinic appointments to determine if the injury is healing properly. If additional surgery is required or other complications arise, this will be recorded within the study follow-up forms.
干预措施: LC fracture surgical fixation (Procedure)
Non-operative
Patients enrolled in the non-operative treatment group will not undergo surgical intervention for their pelvic fracture. They will mobilize as per the surgeon's instructions according to standard of care of for this injury. X-rays will be taken at follow-up clinic appointments to determine if the injury is healing properly or if the pelvis has shifted and may warrant surgical intervention. If complications arise and/or surgery is required, crossover will be allowed and recorded within study follow-up forms.
干预措施: LC fracture non-operative management (Procedure)
结局指标
主要结局
Posttreatment Pain
时间窗: up to 12 weeks post injury
The primary outcome was patient-reported pain severity, as measured by the mean of the 4 pain severity items of the Brief Pain Inventory (BPI): worst pain in the last 24 hours, least pain in the last 24 hours, pain on average, and pain right now. The BPI uses a 0-10 level visual analog scale (VAS) with a 24-hour recall period, where 0 anchors "no pain" and 10 anchors "pain as bad as you can imagine." The minimum clinically important difference (MCID) is not definitively established for the BPI in a trauma population; however, the MCID for other 10-point VAS pain scales has been reported between 1.0-2.5 points.
次要结局
- Length of Hospitalization(through patient discharge, up to 12 weeks post injury)
- Posttreatment Function(up to 12 weeks post injury)
- Time to First Mobilization Post Injury(through patient discharge, up to 12 weeks post injury)
研究者
Robert O'Toole
Head of the UM SOM's Division of Orthpaedic Traumatology and Chief of Orthopaedics for the University of Maryland Medical Center's (UMMC) R Adams Cowley Shock Trauma Center
University of Maryland, Baltimore