Pubic Symphysis DiastasisNCT05763784
Percutaneous TightRope Fixation for Traumatic Pubic Symphysis Diastasis
A study testing Tightrope in people with Pubic Symphysis Diastasis, run by University of Texas Southwestern Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pubic Symphysis Diastasis
- What is being tested?
- Tightrope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age above 18. Pelvic injury with pubic symphysis diastasis necessitating internal fixation. The study will include both English and Spanish speaking patients.
Who cannot join
- Age under 18, hemodynamic instability, Pregnancy, concomitant acetabular fracture, malignancy, open fracture. patient not able to understand and sign informed consent (English and Spanish).
About this study
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.
Read the detailed 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.
- Conditions
- Pubic Symphysis Diastasis
- Being tested
- Tightrope
- Medical subject headings
- Pubic Symphysis Diastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TightropeDevice
Tightrope use special fiber and a set of metal buttons to fix diastasis of a joint.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic Tightrope fixation | Experimental | Theses patients will be treated with Tightrope for their traumatic pubic symphysis diastasis Receives: Device: Tightrope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diastasis healing as measured by x-ray.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Why it stopped: This study plan has halted and was withdrawn from the IRB.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pubic Symphysis DiastasisStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Tiziani, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05763784
- Sponsor's protocol ID
- STU-2021-1070
- Status last verified
- Feb 2023
- First submitted
- 28 Jul 2022
- Last updated
- 10 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous TightRope Fixation for Traumatic Pubic Symphysis Diastasis
- ClinicalTrials.gov ID
- NCT05763784
- Acronym / sponsor ID
- STU-2021-1070
- Conditions
- Pubic Symphysis Diastasis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study plan has halted and was withdrawn from the IRB.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 10 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pelvic Tightrope fixation | Experimental | Device: TightropeTheses patients will be treated with Tightrope for their traumatic pubic symphysis diastasis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age above 18. Pelvic injury with pubic symphysis diastasis necessitating internal fixation. The study will include both English and Spanish speaking patients.
Key exclusion criteria (1 listed)
- Age under 18, hemodynamic instability, Pregnancy, concomitant acetabular fracture, malignancy, open fracture. patient not able to understand and sign informed consent (English and Spanish).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TightropeTightrope use special fiber and a set of metal buttons to fix diastasis of a joint. | Device | Pelvic Tightrope fixation |
Primary outcome
Diastasis healing as measured by x-ray.
Time frame: 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Pubic Symphysis Diastasis
Recruiting
Effects of Pelvic Floor Exercises and Pelvic Support Belt in Symphysis Pubis Dysfunction
Pubic Symphysis Diastasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Tightrope in people with Pubic Symphysis Diastasis, run by University of Texas Southwestern Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diastasis healing as measured by x-ray. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2023.