Pelvic FractureNCT03944174
Single Trans-sacral Screw Versus Two Iliosacral Screws
An observational study of Pelvic Fracture, run by Assiut University.
Trial summary
1. To compare Single Trans-sacral screw fixation vs. two Ilio-Sacral screws fixation as regard time for starting weight bearing. 2. To compare between functional outcome using the Majeed Pelvic Score. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pelvic Fracture
- What is being tested?
- Fixation of unstable pelvic fractures
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2019to Jun 2020
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Any patient between 18 and 60 years old with unstable pelvic fracture admitted to the trauma unit of Assiut University Hospital
Who may be able to join
- Unstable pelvic fractures Tile type B \& C.
- Sacral Fractures.
- Recent trauma: less than 1 week from date of trauma.
- Neurologically free.
- Injury Severity Score (ISS) < 18.
Who cannot join
- Spino-pelvic dissociation.
- Comminuted fractures
- Bilat. Sacral fractures.
- Sacral insufficiency.
- Patients with associated comorbidities "eg. uncontrolled diabetes mellitus , chronic renal failure, etc.".
About this study
Official title: Comparative Study Between Single Trans-sacral Screw Versus Two Iliosacral Screws in Fixation of Unstable Pelvic Fractures
- To compare Single Trans-sacral screw fixation vs. two Ilio-Sacral screws fixation as regard time for starting weight bearing.
- To compare between functional outcome using the Majeed Pelvic Score.
Read the detailed description
Sacroiliac screws (SISs) have been used since Vidal et al introduced them in 1973. Since that, SIS fixation has become a common technology in fixing pelvic posterior ring injuries with important progress in the past 20 years. Currently, SIS fixation represents the only minimally invasive technique to stabilize the posterior pelvic ring. For that reason, it is steadily gaining popularity, becoming one of the most commonly used techniques. The sacrum, serving as the foundation of the spine, transmits the stress between spine and pelvis through sacroiliac joints. Thus, the goal of surgical fixation is the reconstruction of the spino-pelvic-junction to allow early weight-bearing and to facilitate nursing care, particularly for multiple injured patients.
As a result of the deforming forces acting perpendicular to the implant axis, routine ilio-sacral screws fixation may not provide adequate stabilization, especially in certain unstable injuries. Longer trans-sacral screws that traverse the entire upper sacrum and exit the contralateral iliac cortex may improve holding power and also stabilize concomitant contralateral posterior pelvic injuries. These trans-sacral screws are reliably safe to insert using routine intraoperative fluoroscopy, and they provide durable fixation.
- Conditions
- Pelvic Fracture
- Being tested
- Fixation of unstable pelvic fractures
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixation of unstable pelvic fracturesProcedure or surgery
Percutaneous fixation of both iliac bones through the sacrum using one screw
| Study group | Role | What they receive |
|---|---|---|
| Single Trans-sacral Screw | Not described Receives: Procedure: Fixation of unstable pelvic fractures | |
| Two Iliosacral Screws | Not described Receives: Procedure: Fixation of unstable pelvic fractures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early painless weight bearing as tolerated measured by Visual Analogue Scale of Pain (VAS).
Assessment the ability of the patient to start weight bearing without pain as soon as possible by the Visual Analogue Scale of Pain (VAS). It is a continuous scale comprised of a horizontal or vertical line, numbered from 0 to 10 and anchored by 2 verbal descriptors "no pain and worst imaginable pain" one for each symptom extreme from which the patient shall select the degree of pain varying from no pain to worst imaginable pain.
Measured: 2 weeks
To measure the functional outcome using Majeed Pelvic Score system
To assess the effect of the procedure on the daily activities of the patient after pelvic fractures. A system for assessment of function after major pelvic injuries is proposed. This numerical system developed from a five-year prospective study of 60 patients. Five factors were assessed and scored: pain, standing, sitting, sexual intercourse and work performance. The total score then gave a clinical grade as excellent, good, fair or poor. The scoring system allows comparison between early and late results and also between various methods of treatment.
Measured: 6 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study startJun 2019 (estimated)
- Primary completionFeb 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic FractureStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Elhady Hassan Mohammed Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03944174
- Sponsor's protocol ID
- Trans-sacral screw fixation
- Status last verified
- May 2019
- First submitted
- 1 Oct 2018
- Last updated
- 10 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Single Trans-sacral Screw Versus Two Iliosacral Screws in Fixation of Unstable Pelvic Fractures
- ClinicalTrials.gov ID
- NCT03944174
- Acronym / sponsor ID
- Trans-sacral screw fixation
- Conditions
- Pelvic Fracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2019 (estimated)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 9 May 2019 (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.
- To compare Single Trans-sacral screw fixation vs. two Ilio-Sacral screws fixation as regard time for starting weight bearing.
- To compare between functional outcome using the Majeed Pelvic Score.
Detailed description
Sacroiliac screws (SISs) have been used since Vidal et al introduced them in 1973. Since that, SIS fixation has become a common technology in fixing pelvic posterior ring injuries with important progress in the past 20 years. Currently, SIS fixation represents the only minimally invasive technique to stabilize the posterior pelvic ring. For that reason, it is steadily gaining popularity, becoming one of the most commonly used techniques. The sacrum, serving as the foundation of the spine, transmits the stress between spine and pelvis through sacroiliac joints. Thus, the goal of surgical fixation is the reconstruction of the spino-pelvic-junction to allow early weight-bearing and to facilitate nursing care, particularly for multiple injured patients.
As a result of the deforming forces acting perpendicular to the implant axis, routine ilio-sacral screws fixation may not provide adequate stabilization, especially in certain unstable injuries. Longer trans-sacral screws that traverse the entire upper sacrum and exit the contralateral iliac cortex may improve holding power and also stabilize concomitant contralateral posterior pelvic injuries. These trans-sacral screws are reliably safe to insert using routine intraoperative fluoroscopy, and they provide durable fixation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Trans-sacral Screw | – | Procedure: Fixation of unstable pelvic fractures |
| Two Iliosacral Screws | – | Procedure: Fixation of unstable pelvic fractures |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Any patient between 18 and 60 years old with unstable pelvic fracture admitted to the trauma unit of Assiut University Hospital
Key inclusion criteria (5 listed)
- Unstable pelvic fractures Tile type B \& C.
- Sacral Fractures.
- Recent trauma: less than 1 week from date of trauma.
- Neurologically free.
- Injury Severity Score (ISS) < 18.
Key exclusion criteria (5 listed)
- Spino-pelvic dissociation.
- Comminuted fractures
- Bilat. Sacral fractures.
- Sacral insufficiency.
- Patients with associated comorbidities "eg. uncontrolled diabetes mellitus , chronic renal failure, etc.".
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 |
|---|---|---|
| Fixation of unstable pelvic fracturesPercutaneous fixation of both iliac bones through the sacrum using one screw | Procedure or surgery | Single Trans-sacral Screw, Two Iliosacral Screws |
Primary outcome
Early painless weight bearing as tolerated measured by Visual Analogue Scale of Pain (VAS).
Time frame: 2 weeks
Assessment the ability of the patient to start weight bearing without pain as soon as possible by the Visual Analogue Scale of Pain (VAS). It is a continuous scale comprised of a horizontal or vertical line, numbered from 0 to 10 and anchored by 2 verbal descriptors "no pain and worst imaginable pain" one for each symptom extreme from which the patient shall select the degree of pain varying from no pain to worst imaginable pain.
To measure the functional outcome using Majeed Pelvic Score system
Time frame: 6 weeks and 6 months
To assess the effect of the procedure on the daily activities of the patient after pelvic fractures. A system for assessment of function after major pelvic injuries is proposed. This numerical system developed from a five-year prospective study of 60 patients. Five factors were assessed and scored: pain, standing, sitting, sexual intercourse and work performance. The total score then gave a clinical grade as excellent, good, fair or poor. The scoring system allows comparison between early and late results and also between various methods of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
- Visual Analogue Scale of PainLink provided by the sponsor.
- Majeed Pelvic ScoreLink provided by the sponsor.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Fracture, run by Assiut University.
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: status not confirmed, as of the sponsor's last update on 10 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Early painless weight bearing as tolerated measured by Visual Analogue Scale of Pain (VAS). (time frame: 2 weeks). The study lists 2 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 10 May 2019.