Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT05763784 |
| Other study ID # |
STU-2021-1070 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2023 |
| Est. completion date |
September 1, 2025 |
Study information
| Verified date |
February 2023 |
| Source |
University of Texas Southwestern Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
The scope of the study is 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. The authors believe that this fixation method will be more stable then
cannulated screws and as stable as plating. In addition, investigator believes that avoiding
extensile approach needed for plating will have a positive effect on patient's outcome and
rehabilitation.
