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

NCT05683314 · tracked via the Priya Life Science China tracker

Sponsor

China Medical University Hospital

Phase

Observational

Started

2018-01-03

Last updated

2023-01-13

Condition(s) studied

Unstable Sacral/Pelvic or Acetabular Fracture

Investigational drug(s) / intervention(s)

Tranditional open reduction and internal fixation

Tranditional open reduction and internal fixation: Under navigation and bone desity projecting method assisted 3D simulation and printing for minimal invasive surgrey

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.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

EQ-VAS — 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.
EQ-5D — Post-operative at 48th month
EQ-5D is an instrument which evaluates the generic quality of life developed in Europe and widely used.
Majeed pelvic score — Post-operative at 48th month
he Majeed scoring system is a disease-specific outcome measure that was originally designed to assess pelvic injuries.

Trial sites (1)

Facility	City	Region	Status
China Medical University Hospital	Taichung	North District	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05683314 on ClinicalTrials.gov ↗ ← All trials in China