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

January 12, 2023 updated by: Chun-Hao Tsai, China Medical University Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The surgical principles are concluded as:

  1. Sacrum fracture with rotational instability: close reduction and iliosacral screw fixation
  2. Sacrum fracture with vertical shearing instability: open reduction and ipsilateral riangular osteosynthesis with /without neurological decompression

  3. Spinopelvic dissociation: open reduction and bilateral triangular osteosynthesis with

    /without neurological decompression

  4. 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)
  5. Anterior acetabular/ pubic fracture: close /open reduction with plates/screw fixation.
  6. Symphysis dislocation: open reduction with double plates
  7. 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.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
    • North District
      • Taichung, North District, Taiwan, 404327
        • Recruiting
        • China Medical University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chun-Hao Tsai, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

sacral/pelvic or acetabular fracture patients

Description

Inclusion Criteria:

  1. 18 years old and above with the appropriate informed consent
  2. traumatic pelvic or acetabular fracture with 2018 AO/OTA classification
  3. a minimum of 48 months postoperative follow-ups

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Acetabular_Pelvic_Sacral fracture with open reduction and internal fixation
Procedure: Tranditional open reduction and internal fixation
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
Acetabular_Pelvic_Sacral fracture with minimally invasive internal fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Post-operative at 48th month
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.
Post-operative at 48th month
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.
Post-operative at 48th month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
intraoperative blood loss
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.
intraoperative duration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2018

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

January 2, 2029

Study Registration Dates

First Submitted

December 23, 2022

First Submitted That Met QC Criteria

January 12, 2023

First Posted (Estimate)

January 13, 2023

Study Record Updates

Last Update Posted (Estimate)

January 13, 2023

Last Update Submitted That Met QC Criteria

January 12, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUH108-REC3-144

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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