Unstable Sacral/Pelvic or Acetabular FractureNCT05683314
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 of Unstable Sacral/Pelvic or Acetabular Fracture, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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 more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Unstable Sacral/Pelvic or Acetabular Fracture
- What is being tested?
- Tranditional open reduction and internal fixation
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Jan 2018to 2 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: sacral/pelvic or acetabular fracture patients
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung, North District, 404327
Chun-Hao Tsai, PhD, 04-22052121 ext. 5052, ritsai8615@gmail.com
Yu-Han Chang, +886 0909 507 981, arthrokneecmuh@gmail.com
About this study
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:
- 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.
- Being tested
- Tranditional open reduction and internal fixation
- Keywords
- Unstable sacral, Unstable pelvic, acetabular fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranditional open reduction and internal fixationProcedure or surgery
Also called Minimally invassive internal fixation, Navigation, 3D printing modle, 3D simulation
Under navigation and bone desity projecting method assisted 3D simulation and printing for minimal invasive surgrey
| Study group | Role | What they receive |
|---|---|---|
| Acetabular_Pelvic_Sacral fracture with open reduction and internal fixation | Not described Receives: Procedure: Tranditional open reduction and internal fixation | |
| Acetabular_Pelvic_Sacral fracture with minimally invasive internal fixation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Post-operative at 48th month
Secondary outcomes (2)
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.
Measured: 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.
Measured: intraoperative duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start3 Jan 2018
- Primary completion31 Dec 2025 (estimated)
- Study completion2 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unstable Sacral/Pelvic or Acetabular FractureStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun-Hao Tsai, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05683314
- Sponsor's protocol ID
- CMUH108-REC3-144
- Status last verified
- Jan 2023
- First submitted
- 23 Dec 2022
- Last updated
- 13 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Study for Unstable Sacrum/Pelvis and Acetabular Fracture Treated With Open Reduction and Internal Fixation With Minimally Invasive Internal Fixation
- ClinicalTrials.gov ID
- NCT05683314
- Acronym / sponsor ID
- CMUH108-REC3-144
- Keywords
- Unstable sacral, Unstable pelvic, acetabular fracture
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 3 Jan 2018 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 2 Jan 2029 (estimated)
- First posted
- 13 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- sacral/pelvic or acetabular fracture patients
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranditional open reduction and internal fixationAlso: Minimally invassive internal fixation, Navigation, 3D printing modle, 3D simulationUnder navigation and bone desity projecting method assisted 3D simulation and printing for minimal invasive surgrey | Procedure or surgery | Acetabular_Pelvic_Sacral fracture with open reduction and internal fixation |
Primary outcome
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.
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.
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.
2 secondary outcomes
Blood loss
Time frame: intraoperative blood loss
Surgical duration
Time frame: intraoperative duration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unstable Sacral/Pelvic or Acetabular Fracture, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chun-Hao Tsai, PhD (04-22052121 ext. 5052, ritsai8615@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EQ-VAS (time frame: Post-operative at 48th month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2023.