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
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.
The surgical principles are concluded as:
Spinopelvic dissociation: open reduction and bilateral triangular osteosynthesis with
/without neurological decompression
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.
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 →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.
sacral/pelvic or acetabular fracture patients
Exclusion Criteria:
Procedure: Tranditional 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
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
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
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
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
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
Plan to share: No
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China Medical University Hospital