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NCT Number: NCT05683314

A Comparison Study for Unstable Sacrum/Pelvis and Acetabular Fracture Treated With Open Reduction and Internal Fixation With Minimally Invasive Internal Fixation

Unstable sacral/pelvic or acetabular fracture are severe high energy fractures Surgical intervention are necessary after patient's conditions are stable. The complexity of local anatomical structure, the nearby major vessels, organ and visceral structures make the operations difficult and in high risks.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

The surgical principles are concluded as:

  • Sacrum fracture with rotational instability: close reduction and iliosacral screw fixation
  • Sacrum fracture with vertical shearing instability: open reduction and ipsilateral riangular osteosynthesis with /without neurological decompression
  • Spinopelvic dissociation: open reduction and bilateral triangular osteosynthesis with

/without neurological decompression

  • Iliac fracture with sacroiliac joint(SI) joint dislocation: close reduction with iliosacral screw fixation (for SI joint dislocation), anterior open reduction with double plates fixation (for iliac fracture)
  • Anterior acetabular/ pubic fracture: close /open reduction with plates/screw fixation.
  • Symphysis dislocation: open reduction with double plates
  • Acetabulum fracture: posterior open reduction with double plates anterior open /minimally invasive reduction with plates/screw fixation. The implementation of anterior column screw under C-arm X-ray transillumination for pubic fractures was first report in the literature in 1995, and we had this surgical method in our hospital since 2011. The first report of minimally invasive internal fixation in pelvic or acetabular in the literature was reported in 2013, and we had such minimally invasive surgical approach in our hospital since 2014. We would like to retrospectively and prospectively collect the final outcome of these patients and the comparative analysis of different surgical methods in our institution.

AO foundation published an updated fracture and dislocation classification compendium in 2018. Pelvic ring fracture is classified into ABC three type according to intact, incomplete/complete disruption of the posterior arch. Each type of injury is further divided into groups regarding of severity. The old Young Burgess classification of pelvic ring injury has been integrated into this classification. This retrospective study aim to re-classify patients who sustained unstable pelvic fracture and underwent surgery in CMUH under Dr. Tsai since 2009 according to the new system.

The investigators adopted Majeed Pelvic Score for functional outcome and EQ-5D for quality of life evaluation. A telephone survey will be conducted for all patients. Multiple logistic and linear regression analyses will be used for statistical assessment with the MPS and the EQ-5D. This will provide the investigators with the insight of the correlation between injury severity and functional/QOL outcome. Also, the investigators' study aims to determine the prognostic factors relate to poor outcome. Age, mechanism of injury, sex, ISS score, associated injury, surgical method, bladder or neurologic complication, radiologic outcome,unity of fracture will be recorded from medical chart. Statistical analysis will be conducted to identify the correlation between each factor that influence the functional and QOL outcome.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years old and above with the appropriate informed consent
  • traumatic pelvic or acetabular fracture with 2018 AO/OTA classification
  • a minimum of 48 months postoperative follow-ups

Exclusion criteria

  • pelvic or acetabular fractures that were pathological or non-traumatic in nature
  • patients with incomplete follow-up details
  • patients who denied surgical management
  • patients who received external fixation as part of their treatment strategy

Treatment and study plan

Tranditional open reduction and internal fixation

Procedure

Under navigation and bone desity projecting method assisted 3D simulation and printing for minimal invasive surgrey

Other names: Minimally invassive internal fixation, Navigation, 3D printing modle, 3D simulation

Primary outcomes

  1. EQ-VAS

    Time frame: Post-operative at 48th month

    The EQ-VAS is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.

  2. EQ-5D

    Time frame: Post-operative at 48th month

    EQ-5D is an instrument which evaluates the generic quality of life developed in Europe and widely used.

  3. Majeed pelvic score

    Time frame: Post-operative at 48th month

    he Majeed scoring system is a disease-specific outcome measure that was originally designed to assess pelvic injuries.

Secondary outcomes

  1. Blood loss

    Time frame: intraoperative blood loss

    We used a cut-off of 500 cc blood loss. 500 cc was determined in accordance to the American College of Surgeons Advanced Trauma Life Support haemorrhagic shock classification, whereby a 10 to 15% blood volume loss of 500 to 750 cc in a healthy 70 KG human adult would lead to physiological changes.

  2. Surgical duration

    Time frame: intraoperative duration

    4 hours of surgical duration was determined according to a review by Cheng et al. in which 2 to 4 hours of surgery was shown to lead to increased risks of postoperative complications.

Study contacts

Contact information is provided by the study sponsor or research team.

Chun-Hao Tsai, PhD

CONTACT

[email protected]

04-22052121 ext. 5052

Yu-Han Chang

CONTACT

[email protected]

+886 0909 507 981

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2025
Study completion
2029
First posted
Jan 13, 2023
Registry last updated
Jan 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.