Percutaneous TightRope Fixation for Traumatic Pubic Symphysis Diastasis

NCT05763784 | Withdrawn FDA Device

• 1 other identifier: STU-2021-1070
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pubic Symphysis Diastasis

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Study Arms (1)

Pelvic Tightrope fixation

EXPERIMENTAL

Theses patients will be treated with Tightrope for their traumatic pubic symphysis diastasis

Device: Tightrope

Interventions

Tightrope DEVICE

Tightrope use special fiber and a set of metal buttons to fix diastasis of a joint.

Pelvic Tightrope fixation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age above 18. Pelvic injury with pubic symphysis diastasis necessitating internal fixation. The study will include both English and Spanish speaking patients.

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

MeSH Terms

Conditions

Pubic Symphysis Diastasis

Condition Hierarchy (Ancestors)

Diastasis, Bone; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Trainee

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: March 10, 2023
• Study Start: December 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: March 10, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share