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临床试验/NCT05075382
NCT05075382撤回不适用

Fracture and Neurological Injury: Prospective Multicentre Study on Risk Factors of Complications and Opioid Intake in Elbow Trauma

Université de Montréal0 个研究点开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Measurement of inflammatory factors with blood tests

研究概览

简要总结

The goal of the project is to describe novel factors affecting outcome after elbow fracture surgery with an in-depth evaluation of the role played by neuro inflammation from concomitant peripheral nerve injury or head injury in elbow fracture outcomes.

Among all upper limb fractures, elbow trauma is the most frequently associated with a severe impact on patient function and quality of life. One of the main reasons for poor outcomes is the complexity of the elbow joint, which involves three bones and two planes of motion, essential to position the hand in space. The flexion extension axis is crucial for eating and hygiene, while forearm pro-supination is mandatory for most professions, from office work to manual labour.

详细描述

Elbow fractures are a challenging clinical problem. The advancement of science and technology has made major contributions to improve outcomes. Nonetheless, even with an anatomical restoration of the bone architecture, many patients stay with major limitations and pain. In clinical practice, it is striking to see how two patients with a similar elbow injury can exhibit completely opposite presentations: one who has completely healed from his/her injury and the other who has a stiff and painful elbow. The reasons for these changeable outcomes are unclear.

The investigator hypothesize that many of the answers will be related to the neurological system. This would explain why most studies strictly focusing on the orthopedic component of upper limb injury have yielded little improvement in preventing the adverse outcomes experienced by patients.

Following surgical treatment of an elbow fracture, patients often present with complications. Indeed, one third of patients complain of ulnar nerve symptoms after distal humerus fracture fixation, and 50% of patients treated surgically for elbow fracture-dislocations will have disabling stiffness and heterotopic ossification (HO). HO results from resident cells of mesenchymal origin in soft tissues transforming into bone. Furthermore, approximately half of all patients with fractures feel significant pain leading to persistent narcotic intake 3 months post injury; 40% will suffer from a neuropathic type of pain, which is poorly controlled by narcotic medication. Opioid usage is also related to increased sensitivity to pain (hyperalgesia) and dissatisfaction. Complications from opioids prolonged usage are numerous, from constipation to death due to an overdose. Canada is second worldwide, behind the United States, when it comes to opioid use and mortality secondary to opioid use. The majority of opioid dependant users were first exposed to these substances through medical prescriptions. This makes it imperative to improve the scinetific community understanding of pain mechanisms and find alternative treatments to opiates in the management of these injuries.

In view of these observations, the investigator's research must focus on something other than "satisfactory radiological results" in patients with elbow injuries. To this end, a multidisciplinary approach is needed. The investigators oversee research in elbow trauma, neurotrauma and have an expertise in upper limb evaluation. To improve the understanding of the underlying physiological principles that contribute to pain and chronic stiffness, one of the topics targeted by the investigator is the role of neuro-inflammation (NI) in chronic pain and functional limitation in elbow trauma. The surgical factors that increase NI will allow surgeons to choose different therapeutic options and develop novel treatments.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult 18 years or older with an acute elbow fracture and dislocation less than a week old
  • Open or arthroscopic surgery as the chosen treatment

排除标准

  • Patient with a history of ipsilateral trauma, neurological disorder or major pathology.
  • Patient unable to answer questionnaires.
  • Patient unavailable for a one-year follow-up, for example from another country.
  • Patient with vascular injury or open fracture
  • Patient with a historic of TBI
  • Patient with chronic medicated pain

结局指标

主要结局

Measurement of inflammatory factors with blood tests

时间窗: 3 months post-op

interleukins, P substance, TNF alpha, osteopontin, S100B, NSE, GFAP

次要结局

  • Patient rated elbow evaluation (PREE)(Baseline, 2 weeks post-op, 3-6-12 months post-op)
  • Range of motion(Baseline, 2 weeks post-op, 3-6-12 months post-op)
  • Quick-DASH(Baseline, 2 weeks post-op, 3-6-12 months post-op)
  • McGill Pain Questionnaire (MPQ-Short Form V2)(Baseline, 2 weeks post-op, 3-6-12 months post-op)
  • Tourniquet(Per-op)
  • Nerve dissection(Pero-op)
  • Neuropathic pain questionnaire (SLANSS)(Baseline, 2 weeks post-op, 3-6-12 months post-op)
  • Euro-Qol Group 5Q5D(Baseline, 2 weeks post-op, 3-6-12 months post-op)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dominique Rouleau

Principal investigator

Université de Montréal

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