Sacral FractureNCT06755580
Comparison of Minimally Invasive Versus Open Spinopelvic Fixation for Unstable Sacral Fractures
An observational study of Sacral Fracture, run by F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica at 1 site in Slovakia.
Trial summary
The aim of this retrospective study is to evaluate patients with vertically unstable high-energy sacral fracture operated on at our institution with spinopelvic fixation, to compare the traditionally open method of fixation with the minimally invasive fixation. Read more about this study
- Who is it for?
- Ages 16 to 77 years
- Conditions the study is for
- Sacral Fracture
- What is being tested?
- spinopelvic fixation
- Type of treatment
- Surgery or procedure
- How many people
- 51 participants
- Where
- 1 siteSlovakia
- Study dates
- 1 Jan 2014to 18 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 to 77 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients operated at our institution
Who may be able to join
- patient with high energy vertically unstable sacral fracture
- patients operated with open or minimally invasive spinopelvic fixation
- patients followed up for at least one year
Who cannot join
- patients with low-energy osteoporotic fractures of the sacrum
- patients with insufficiency fractures of the sacrum
- patients operated on using a method other than spinopelvic fixation
- patients who were not followed up for at least one year after surgery
Trial locations and contacts
1 site in 1 country.
Slovakia1 site
F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
Banská Bystrica, 97517
About this study
The aim of this retrospective study is to evaluate patients with vertically unstable high-energy sacral fracture operated on at our institution with spinopelvic fixation, to compare the traditionally open method of fixation with the minimally invasive fixation. The aim of the research is to determine whether minimally invasive surgical techniques can achieve comparable fracture reduction and functional outcome as open surgical approaches. Another aim is to determine whether the minimally invasive surgical procedure leads to shorter patient hospitalization, lower perioperative blood loss, and lower postoperative complications.
Read the detailed description
This retrospective study included 51 patients with vertically unstable sacral fracture operated at our institution with open or minimally invasive spinopelvic fixation over a period of 11 years (2014-2024). The patients were divided into two groups. One group of patients underwent open spinopelvic fixation, the other group underwent minimally invasive spinopelvic fixation. Each patient underwent a CT scan before and after surgery. The degree of fracture dislocation and reduction was measured in three planes at each examination. The degree of reduction was divided into four groups according to residual dislocation. In the perioperative period, blood loss, the length of the surgical procedure from the first incision to the suture of the wounds, and radiation exposure were monitored. Intraoperative blood loss was calculated from the waste in the surgical suction system. Functional outcome was assessed one year after surgery. A standardized questionnaire according to the Majeed score was used to assess functional outcome.
- Conditions
- Sacral Fracture
- Being tested
- spinopelvic fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinopelvic fixationProcedure or surgery
open and minimally invasive spinopelvic fixation for unstable or dislocated high-energy sacral fractures
| Study group | Role | What they receive |
|---|---|---|
| patients operated with open spinopelvic fixation | patients with vertically unstable high-energy sacral fracture operated with traditionally open spinopelvic fixation Receives: Procedure: spinopelvic fixation | |
| patients operated with minimally invasive spinopelvic fixation. | patients with vertically unstable high-energy sacral fracture operated with minimally invasive spinopelvic fixation Receives: Procedure: spinopelvic fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
pelvic ring symmetry
position of fracture fragments before and after surgery measured in three planes on CT scan
Measured: up to 1 year
invasiveness of the surgical procedure
The invasiveness of the surgical procedure was measured based on perioperative blood loss. Perioperative blood loss was calculated from the waste in the surgical suction system (mililiters)
Measured: in perioperative period
length of the surgical procedure
length of the surgical procedure from the first incision to the suture of the wounds
Measured: in perioperative period
radiation exposure of the patient during surgical procedure
radiation exposure of a patient during a surgical procedure measured by the X-ray machine used during the operation (microgray/m2)
Measured: in perioperative period
Functional outcome after surgery based on a standardized questionnaire according to the Majeed score
One year after surgery, patients fill out a standardized questionnaire according to the Majeed scoring system. Majeed score is a pelvic injury-specific functional assessment that comprises seven items, including pain, work, sitting, sexual intercourse, standing, unaided gait, and walking distance, with a total score range of 0 (worst outcome) to100 (best outcome), in order of decreasing disability.
Measured: one year after surgery
complications
During the observation period, postoperative complications such as wound infection, loosening of osteosynthetic material, loss of reduction, nonunion, and newly developed neurological deficit will be recorded in patients.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start1 Jan 2014
- Primary completion16 Dec 2024
- Study completion18 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacral FractureStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hrin Tomas, MD, F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
- Investigators
- Tomas Hrin, MD, Principal investigator, F.D. Roosevelt Teaching Hospital with Policlinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755580
- Sponsor's protocol ID
- 12/2024
- Status last verified
- Feb 2025
- First submitted
- 20 Dec 2024
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: plan to share all collected IPD
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Minimally Invasive Versus Open Spinopelvic Fixation for Unstable Sacral Fractures
- ClinicalTrials.gov ID
- NCT06755580
- Acronym / sponsor ID
- 12/2024
- Conditions
- Sacral Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- F.D. Roosevelt Teaching Hospital with Policlinic Banska BystricaUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 16 Dec 2024 (actual)
- Study completion
- 18 Dec 2024 (actual)
- First posted
- 1 Jan 2025 (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.
The aim of this retrospective study is to evaluate patients with vertically unstable high-energy sacral fracture operated on at our institution with spinopelvic fixation, to compare the traditionally open method of fixation with the minimally invasive fixation. The aim of the research is to determine whether minimally invasive surgical techniques can achieve comparable fracture reduction and functional outcome as open surgical approaches. Another aim is to determine whether the minimally invasive surgical procedure leads to shorter patient hospitalization, lower perioperative blood loss, and lower postoperative complications.
Detailed description
This retrospective study included 51 patients with vertically unstable sacral fracture operated at our institution with open or minimally invasive spinopelvic fixation over a period of 11 years (2014-2024). The patients were divided into two groups. One group of patients underwent open spinopelvic fixation, the other group underwent minimally invasive spinopelvic fixation. Each patient underwent a CT scan before and after surgery. The degree of fracture dislocation and reduction was measured in three planes at each examination. The degree of reduction was divided into four groups according to residual dislocation. In the perioperative period, blood loss, the length of the surgical procedure from the first incision to the suture of the wounds, and radiation exposure were monitored. Intraoperative blood loss was calculated from the waste in the surgical suction system. Functional outcome was assessed one year after surgery. A standardized questionnaire according to the Majeed score was used to assess functional outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients operated with open spinopelvic fixation | – | Procedure: spinopelvic fixationpatients with vertically unstable high-energy sacral fracture operated with traditionally open spinopelvic fixation |
| patients operated with minimally invasive spinopelvic fixation. | – | Procedure: spinopelvic fixationpatients with vertically unstable high-energy sacral fracture operated with minimally invasive spinopelvic fixation |
Who may qualify
- Ages
- 16 to 77 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients operated at our institution
Key inclusion criteria (3 listed)
- patient with high energy vertically unstable sacral fracture
- patients operated with open or minimally invasive spinopelvic fixation
- patients followed up for at least one year
Key exclusion criteria (4 listed)
- patients with low-energy osteoporotic fractures of the sacrum
- patients with insufficiency fractures of the sacrum
- patients operated on using a method other than spinopelvic fixation
- patients who were not followed up for at least one year after surgery
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 |
|---|---|---|
| spinopelvic fixationopen and minimally invasive spinopelvic fixation for unstable or dislocated high-energy sacral fractures | Procedure or surgery | patients operated with minimally invasive spinopelvic fixation., patients operated with open spinopelvic fixation |
Primary outcome
pelvic ring symmetry
Time frame: up to 1 year
position of fracture fragments before and after surgery measured in three planes on CT scan
invasiveness of the surgical procedure
Time frame: in perioperative period
The invasiveness of the surgical procedure was measured based on perioperative blood loss. Perioperative blood loss was calculated from the waste in the surgical suction system (mililiters)
length of the surgical procedure
Time frame: in perioperative period
length of the surgical procedure from the first incision to the suture of the wounds
radiation exposure of the patient during surgical procedure
Time frame: in perioperative period
radiation exposure of a patient during a surgical procedure measured by the X-ray machine used during the operation (microgray/m2)
Functional outcome after surgery based on a standardized questionnaire according to the Majeed score
Time frame: one year after surgery
One year after surgery, patients fill out a standardized questionnaire according to the Majeed scoring system. Majeed score is a pelvic injury-specific functional assessment that comprises seven items, including pain, work, sitting, sexual intercourse, standing, unaided gait, and walking distance, with a total score range of 0 (worst outcome) to100 (best outcome), in order of decreasing disability.
complications
Time frame: 1 year
During the observation period, postoperative complications such as wound infection, loosening of osteosynthetic material, loss of reduction, nonunion, and newly developed neurological deficit will be recorded in patients.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Individual participant dataSharing planned: Yes. plan to share all collected IPD
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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. This study is not recruiting at the moment.
Tomas Hrin, MD principal investigator
F.D. Roosevelt Teaching Hospital with Policlinic
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 Sacral Fracture, run by F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica at 1 site in Slovakia.
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: finished, as of the sponsor's last update on 24 Feb 2025. 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 Slovakia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pelvic ring symmetry (time frame: up to 1 year). The study lists 6 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 24 Feb 2025.