FixationNCT06888583
Fixation of Unstable Sacral Fractures by Transpedicular System
An observational study of Fixation and Unstable Sacral Fractures, run by Tanta University at 1 site in Egypt.
Trial summary
This research aimed to assess the role of the transpedicular Fixation system in the management of unstable sacral fractures in adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fixation, Unstable Sacral Fractures, Transpedicular Sacral Fixation
- What is being tested?
- Transpedicular fixation
- Type of treatment
- Surgery or procedure
- How many people
- 21 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2022to 1 Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This prospective case series study was conducted on 21 patients with unstable sacral fractures at Tanta and Assiut University Hospitals from May 2022 to August 2024.
Who may be able to join
- Adult patients over 18 years old age.
- Both sexes.
- Unstable AO sacral fracture type B and type C.
- Patient fit for surgery and hemodynamic stable patient.
- Closed fracture.
Who cannot join
- AO sacral fracture type A.
- Bedridden before the trauma.
- Patient unfit for surgery.
- Open sacral fractures.
- Sacral fractures with massive morel-lavallee lesions.
Trial locations and contacts
1 site in 1 country.
About this study
This research aimed to assess the role of the transpedicular Fixation system in the management of unstable sacral fractures in adults.
Read the detailed description
Pelvic ring disruptions are high-energy injuries with a significant impact on quality of life and higher levels of mortality. Unstable sacral fracture is an unusual injury, and even though many studies implicate the surgical intervention as the treatment of choice, the purposes of surgery on sacral fractures include pelvic ring reconstruction, lumbopelvic stability restoration, fracture healing, early mobilization, fracture displacement prevention and improving the neurological deficiency. More and more surgeons are advocating for surgical management in the treatment of sacral fractures, and open reduction internal fixation (ORIF) has demonstrated marked benefits over conservative treatment.
- Being tested
- Transpedicular fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transpedicular fixationProcedure or surgery
Patients underwent transpedicular sacral fixation.
| Study group | Role | What they receive |
|---|---|---|
| Transpedicular fixation group | Patients underwent transpedicular sacral fixation. Receives: Procedure: Transpedicular fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome
Function results were assessed in terms of pain, standing and sitting, sexual function, and the need of assistance when walking, walking distance, and gait according to scoring system proposed by Majeed score. Five factors were assessed and scored: pain (30 points), standing (36 points), sitting (10 points), sexual intercourse (4 points) and work performance (20 points). The total score then gave a clinical grade as excellent (>85 points), good (70-84 points), fair (55-69 points) or poor (<55 points).
Measured: 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start1 May 2022
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FixationStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Elsayed Elmoghany, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888583
- Sponsor's protocol ID
- 35358/3/22
- Status last verified
- Mar 2025
- First submitted
- 15 Mar 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Publications
Elmoghany ME, Gharbo NO, Ayoub MA, Farouk OA, Mashal HEY. Fixation of unstable sacral fractures by transpedicular system: a prospective study. Int Orthop. 2026 Jan;50(1):219-228. doi: 10.1007/s00264-025-06673-3. Epub 2025 Nov 14.
PubMed 41233652
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fixation of Unstable Sacral Fractures by Transpedicular System
- ClinicalTrials.gov ID
- NCT06888583
- Acronym / sponsor ID
- 35358/3/22
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 21 Mar 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.
This research aimed to assess the role of the transpedicular Fixation system in the management of unstable sacral fractures in adults.
Detailed description
Pelvic ring disruptions are high-energy injuries with a significant impact on quality of life and higher levels of mortality. Unstable sacral fracture is an unusual injury, and even though many studies implicate the surgical intervention as the treatment of choice, the purposes of surgery on sacral fractures include pelvic ring reconstruction, lumbopelvic stability restoration, fracture healing, early mobilization, fracture displacement prevention and improving the neurological deficiency. More and more surgeons are advocating for surgical management in the treatment of sacral fractures, and open reduction internal fixation (ORIF) has demonstrated marked benefits over conservative treatment.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transpedicular fixation group | – | Procedure: Transpedicular fixationPatients underwent transpedicular sacral fixation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This prospective case series study was conducted on 21 patients with unstable sacral fractures at Tanta and Assiut University Hospitals from May 2022 to August 2024.
Key inclusion criteria (5 listed)
- Adult patients over 18 years old age.
- Both sexes.
- Unstable AO sacral fracture type B and type C.
- Patient fit for surgery and hemodynamic stable patient.
- Closed fracture.
Key exclusion criteria (5 listed)
- AO sacral fracture type A.
- Bedridden before the trauma.
- Patient unfit for surgery.
- Open sacral fractures.
- Sacral fractures with massive morel-lavallee lesions.
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 |
|---|---|---|
| Transpedicular fixationPatients underwent transpedicular sacral fixation. | Procedure or surgery | Transpedicular fixation group |
Primary outcome
Functional outcome
Time frame: 1 year postoperatively
Function results were assessed in terms of pain, standing and sitting, sexual function, and the need of assistance when walking, walking distance, and gait according to scoring system proposed by Majeed score. Five factors were assessed and scored: pain (30 points), standing (36 points), sitting (10 points), sexual intercourse (4 points) and work performance (20 points). The total score then gave a clinical grade as excellent (>85 points), good (70-84 points), fair (55-69 points) or poor (<55 points).
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 21 Mar 2025.
- Derived from this study: PubMed 41233652Elmoghany ME, Gharbo NO, Ayoub MA, Farouk OA, Mashal HEY. Fixation of unstable sacral fractures by transpedicular system: a prospective study. Int Orthop. 2026 Jan;50(1):219-228. doi: 10.1007/s00264-025-06673-3. Epub 2025 Nov 14.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Fixation and Unstable Sacral Fractures, run by Tanta University at 1 site in Egypt.
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 5 inclusion and 5 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 21 Mar 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 Egypt. 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?
Functional outcome (time frame: 1 year postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06888583, which also lists 1 linked publication.
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 21 Mar 2025.