The Effect of Sacroiliac (SI) Screw Removal on Patient-Reported Pain and Functional Outcomes After Open or Closed Reduction and Internal Fixation of Pelvic Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Post-operative Pain Within 6 Months After Iliosacral Screw Removal Using the Brief Pain Inventory (BPI)
研究概览
简要总结
Chronic pain following surgical stabilization of a pelvic fracture is very prominent and can have a major affect on a patient's quality of life. Persistent pain after radiographic evidence of fracture union commonly leads to implant removal. But, the routine removal of orthopaedic fixation devices after fracture healing remains an issue of debate.
详细描述
Many surgeons remember patients whose intractable, hardly explainable local symptoms and complaints of pain resolved quickly after a hardware-removal procedure. However, implant removal requires a second surgical procedure in scarred tissue, poses a risk for nerve damage, infection and re-fractures, and is not a guarantee of pain relief.
Rates of implant removal vary based on anatomic location and implant selection. Many studies have introduced and assessed the outcomes of hardware removal in the ankle, tibia and femur. But, there is currently no controlled trial that assesses the benefits and harms of sacroiliac (SI) screw removal in pelvic fracture patients.
Reports in literature are not consistent concerning the incidence of painful hardware and the outcome and pain relief after hardware removal. There is conflicting evidence that removing hardware decreases acute pain in ankle, tibia, and femur fractures but there is a need to explore the effect of SI screw removal in pelvic fracture patients. The investigators propose to prospectively randomize patients with a pelvic fracture requiring the use of SI screws for stabilization to removal versus non-removal of SI screws and track which group has less pain and need for narcotic pain medications.
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 is between 18 and 80 years of age, inclusive
- •The patient has a pelvic fracture that required SI screw stabilization
- •The patient has reached skeletal maturity
- •The patient's pelvic fracture was the result of trauma (includes polytraumatized patients)
- •The patient is English-speaking
- •The patient's pelvic fracture was initially treated at Shock Trauma
- •The patient is currently experiencing pain associated with his/her pelvic fracture
- •The patient's surgeon agrees to randomization (the patient is amendable to either SI screw removal or non-screw removal treatment)
- •The patient is able to be randomized between 4 and 8 months post-SI screw stabilization surgery at an orthopaedic follow-up appointment
排除标准
- •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 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
Screw Removal
Patients enrolled in the SI screw removal treatment group will undergo the surgery 5-9 months after the initial SI screw stabilization surgery. The surgeon will remove all screws that he/she is able and feels is appropriate for the patient. The patient will mobilize as per the surgeon's instructions and x-rays will be taken at follow-up clinic appointments as per standard of care to determine if the injury continues 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: SI Screw Removal Surgery (Procedure)
Non-screw Removal
Patients enrolled in the Non-SI screw removal treatment group will not undergo surgical intervention to for removal of their SI screws. remove all screws that he/she is able and feels is appropriate for the patient. The patient will mobilize as per the surgeon's instructions and x-rays will be taken at follow-up clinic appointments as per standard of care to determine if the injury continues healing properly. If complications arise and/or the patient requires screw removal surgery, crossover will be allowed and recorded within study follow0up forms.
干预措施: Non-screw removal treatment (non-operative management) (Procedure)
结局指标
主要结局
Post-operative Pain Within 6 Months After Iliosacral Screw Removal Using the Brief Pain Inventory (BPI)
时间窗: Up to 24 months post initial SI screw stabilization
The BPI is presented on a 0-10 level visual analog scale with a 24-hour recall period. A level of 0 is described to the patients as "no pain," and "10" described as "pain as bad as you can imagine." The BPI includes four items: the worst pain the patient has felt in the last 24 hours, the least pain the patient has felt in the last 24 hours, the average pain the patient has felt in the last 24 hours, and the pain the patient feels right now. The BPI score is the average of the four items.
次要结局
- Pelvic Function Within 6 Months After Iliosacral Screw Removal, Measured Using the Majeed Pelvic Outcome Score.(Up to 24 months post initial SI screw stabilization)
研究者
Marcus Sciadini
Associate Professor in Orthopaedics
University of Maryland, Baltimore