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RecruitingNCT05683314Updated Jan 13, 2023

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

An observational study in Unstable Sacral/Pelvic or Acetabular Fracture, sponsored by China Medical University Hospital. Recruiting at 1 site in Taiwan. Per ClinicalTrials.gov, last updated 2023-01-13.

Sponsored by China Medical University Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Jan 2018; still recruiting 8 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Sex
All
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Study summary

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.

Read the 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.

02

Conditions studied

  • Unstable Sacral/Pelvic or Acetabular Fracture

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Keywords

  • Unstable sacral
  • Unstable pelvic
  • acetabular fracture
03

In context

Fractures, Bone

2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.

This study's planned enrollment of 300 is above the median of 100 across 675 observational studies indexed under Fractures, Bone.

Browse Fractures, Bone studies →

Lead sponsor

China Medical University Hospital is the lead sponsor of 464 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

sacral/pelvic or acetabular fracture patients

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • Acetabular_Pelvic_Sacral fracture with open reduction and internal fixation

    Procedure: Tranditional open reduction and internal fixation

  • Acetabular_Pelvic_Sacral fracture with minimally invasive internal fixation

Interventions

  • ProcedureTranditional open reduction and internal fixation

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

    Also known as: Minimally invassive internal fixation, Navigation, 3D printing modle, 3D simulation

06

What researchers measure

Primary outcomes

  1. EQ-VAS

    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.

    Time frame: Post-operative at 48th month

  2. EQ-5D

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

    Time frame: Post-operative at 48th month

  3. Majeed pelvic score

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

    Time frame: Post-operative at 48th month

Secondary outcomes

  1. 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.

    Time frame: intraoperative blood loss

  2. Surgical 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.

    Time frame: intraoperative duration

07

Study locations

1 of 1 sites recruiting
  • China Medical University Hospital
    Taichung, North District 404327, Taiwan
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05683314
Lead sponsor
China Medical University Hospital
Responsible party
Chun-Hao Tsai (Medical doctors, Department of Orthopedics , Principal Investigator, Clinical Professor, China Medical University Hospital) — Principal investigator
First posted
Jan 13, 2023
Start date
Jan 3, 2018
Primary completion
Dec 31, 2025 (estimated)
Completion
Jan 2, 2029 (estimated)
Last update
Jan 13, 2023

Study contacts

Chun-Hao Tsai, PhD
Contact
ritsai8615@gmail.com
04-22052121 ext. 5052
Yu-Han Chang
Contact
arthrokneecmuh@gmail.com
+886 0909 507 981

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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