跳至主要内容
临床试验/NCT05763784
NCT05763784撤回不适用

Percutaneous TightRope Fixation for Traumatic Pubic Symphysis Diastasis

University of Texas Southwestern Medical Center0 个研究点开始时间: 2023年12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
Diastasis healing as measured by x-ray.

研究概览

简要总结

This study is done to evaluate the safety of a minimal anterior approach to the pubis symphysis and to examine the efficacy of TightRope for internal fixation of pubic symphysis traumatic diastasis.

详细描述

Pelvic ring injuries are a challenging task for the orthopaedic surgeon. Commonly, these are associated with hemorrhagic shock, head injury and abdominal trauma. Mortality rate is high and ranges between 11 and 57 percent Pelvic ring injuries are found in polytrauma patients. As such, perioperative complications are not uncommon and comprise shock, sepsis, acute respiratory distress syndrome (ARDS), Multiorgan dysfunction syndrome (MODS), compensatory anti-inflammatory response syndrome (CARS) , sexual dysfunction , and chronic pain.

Reduction and fixation of these injuries is difficult due to complex pelvic anatomy and powerful deforming musculature forces. Often, anatomical restoration requires extensile exposures with considerable biologic burden on the already injured patient. Open reduction is a risk factor for surgical site infections and possible sepsis. The latter is highly associated with increased Body Mass Index (BMI) and risk of postoperative infection.

Minimal invasive pelvic surgery, using closed reduction and percutaneous screws can reduce intraoperative blood loss and shock, decrease mortality rates, postoperative infections and sepsis. In addition, minimal invasive surgery has been shown to be as effective as formal open reduction surgery. Patients with soft tissue compromise such as degloving injuries or burns can also benefit from incorporating minimal invasive surgery.

Internal fixation of pelvic injury is broadly classified to posterior elements (Sacrum, Sacroiliac joint and Sacrotuberous and sacrospinous ligaments) and anterior elements (Pubic symphysis, pectineal ridge and rami). Currently, percutaneous fixation of the Sacroiliac components is widely done, however, formal open reduction using an extensive approach and symphyseal plating remains the gold standard for fixation of the pubis symphysis diastasis.

Currently the management of symphyseal injuries is still one that the overwhelming body of pelvic surgeons would still treat with open reduction and plating via a Pfannenstiel approach. This is because of the relative ease of accessibility to the anterior pelvic ring, good access to the surgical target, low incisional hernia rates and perceived low infection rates. This technique is not without its disadvantages though. The approach requires dissection through a complex anatomical region. Access for plate insertion often requires lateral incision extension, particularly in larger patients. This can increase the risk of damage to inguinal canal and its contents. This can result in ongoing pain symptoms. The approach also sometimes requires the detachment of the distal insertion of the rectus abdomens muscles. The sequelae of this were discussed by Pennal In this study the investigator aims to test a new pubic symphysis diastasis fixation strategy, using the TightRope device combined with a percutaneous anterior approach. TightRope device (Arthrex) is wildly used in orthopaedic surgery for ankle syndesmotic fixation . This device utilizes two metal buttons that can be inserted to attach to bone segments, through a single drill hole. Compression between the two buttons is achieved by pooling the external threads. Following proper reduction and sufficient compression the device is automatically fixed by a locking mechanism in the superficial button. TightRope has been shown to be as strong as conventional 3.5 mm stainless steel screws used in pubic symphysis fixation . In addition, TightRope fixation can potentially decrease the high failure rate of symphyseal plating, reporting to be between 12-33%. In this study a custom-made TightRope prototype made for symphysis diastasis will be used.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • Age above
  • Pelvic injury with pubic symphysis diastasis necessitating internal fixation. The study will include both English and Spanish speaking patients.

排除标准

  • Age under 18, hemodynamic instability, Pregnancy, concomitant acetabular fracture, malignancy, open fracture. patient not able to understand and sign informed consent (English and Spanish).

结局指标

主要结局

Diastasis healing as measured by x-ray.

时间窗: 2 years

Diastasis healing will be measured by x-ray. x-ray images will be taken during the initial procedure and on each follow-up. The distance will be measured from the most medial side of each side of the superior rami. Any widening will be compared to post operative x-ray and measured in centimeters. The bigger the gap the less stabilized the pubic symphysis.

次要结局

未报告次要终点

研究者

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

Simon Tiziani

Postdoctoral Trainee

University of Texas Southwestern Medical Center

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