High-energy TraumaNCT07571798
The Difference of Two and Three Fluoroscopic Views of Sacrum for Percutaneous Sacroiliac Screw Insertion in High Energy Posterior Pelvic Ring Injured Patients
A study testing Percutaneous sacroiliac screw fixation using two or three fluoroscopic views in people with High-energy Trauma and Sacral Fractures, run by Chonburi hospital at 1 site in Thailand.
Trial summary
The goal of this clinical trial is to learn about the surgical techniques of percutaneous sacroiliac screw fixation both the two-view fluoroscopic technique (sacral inlet and outlet views) and the standard three-view fluoroscopic technique (lateral, sacral inlet, and sacral outlet views). Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- High-energy Trauma, Sacral Fractures, Posterior Pelvic Ring Injury
- What is being tested?
- Percutaneous sacroiliac screw fixation using two or three fluoroscopic views
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteThailand
- Study dates
- 1 Feb 2026to 1 May 2026
- Phase
- Interventional
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with traumatic posterior pelvic ring or sacral fractures indicated percutaneous screw fixation.
- Patients who are fully conscious, possess decision-making capacity, and can provide informed consent.
Who cannot join
- Presence of severe sacral dysmorphism (sacral dysmorphic score > 70 and absence of osseous corridor)
- Concomitant diagnosis of osteoporosis or age more than 60 years
- Age under 20 years or evidence of skeletal immaturity
- Pregnancy
- Highly comminuted sacral fractures precluding accurate intraoperative assessment of the screw trajectory
- Pre-existing lumbosacral neurological deficits prior to surgery
Show all 10Show fewer
- Withdrawal Criteria:
- Intraoperative necessity to convert to an alternative surgical method (e.g., inability to safely proceed with percutaneous fixation).
- Absence of postoperative computed tomography (CT) scan
- Loss to follow-up within 2 months postoperatively
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Chonburi Hospital, 69 Moo 2 Sukhumvit Road
Chon Buri, Changwat Chon Buri, 20000
About this study
Official title: The Difference of Two and Three Fluoroscopic Views of Sacrum for Percutaneous Sacroiliac Screw Insertion in High Energy Posterior Pelvic Ring Injured Patients, a Double-blinded Randomized Controlled Trial
The goal of this clinical trial is to learn about the surgical techniques of percutaneous sacroiliac screw fixation both the two-view fluoroscopic technique (sacral inlet and outlet views) and the standard three-view fluoroscopic technique (lateral, sacral inlet, and sacral outlet views).
The main questions it aims to answer is:
Read more
- Is there any difference of the operative time, intraoperative radiation exposure time, screw malposition rate, and postoperative neurological complication rate for percutaneous pelvic screw fixation between two techniques?
Researchers will compare two surgical techniques of percutaneous sacroiliac screw fixation in high energy posterior pelvic ring injured patients.
Participants will:
- Be examined neurological status carefully before and after the operation
- Get both preoperative and postoperative CT scan
- Undergo the percutaneous sacroiliac screw(s) fixation with or without anterior plating fixation
- Being tested
- Percutaneous sacroiliac screw fixation using two or three fluoroscopic views
- Keywords
- Sacral fracture, Fluoroscopic view, Orthopedic trauma, Percutaneous SI screw, Pelvic injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous sacroiliac screw fixation using two or three fluoroscopic viewsProcedure or surgery
Surgeon will insert the SI screw percutaneously using sacral inlet, sacral outlet fluoroscopic views with or without lateral sacral view
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous SI screw insertion using two fluoroscopic views | Active comparator | Patients with posterior pelvic ring or sacral injuries resulting from high-energy trauma who required the sacroiliac screw fixation.
Surgeon will insert the SI screw percutaneously using sacral inlet and sacral outlet fluoroscopic views Receives: Procedure: Percutaneous sacroiliac screw fixation using two or three fluoroscopic views |
| Percutaneous SI screw insertion using three fluoroscopic views | Active comparator | Patients with posterior pelvic ring or sacral injuries resulting from high-energy trauma who required the sacroiliac screw fixation.
Surgeon will insert the SI screw percutaneously using lateral, sacral inlet and sacral outlet fluoroscopic views Receives: Procedure: Percutaneous sacroiliac screw fixation using two or three fluoroscopic views |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
Operative time in minutes that takes for insertion of guide pin of cannulated SI screw; From the time of skin incision to the final acceptable positioning of the guide pin (prior to screw insertion)
Measured: perioperative record
Secondary outcomes (3)
Radiation Exposure Time
Cumulative fluoroscopy time in seconds; From the first fluoroscopic image to the final image confirming guide pin placement
Measured: Perioperative record
Neurological complications by physical examinations and symptoms
Neurological examinations will be assessed and recorded by an independent orthopedic resident blinded to the allocation. The evaluations include radiation pain by visual analog score, L5 and S1 motor power by physical examination motor grading scale, L5 and S1 sensation deficit (yes or no), perianal sensation deficit (yes or no), bowel bladder symptoms (yes or no), sphincter tone deficit (yes or no)
Measured: Immediate postoperative to two months after operation
Screw malposition
Screw malpositions of S1 screw (yes or no) include cortical breakage (sacral ala, endplate, anterior cortex, ilium), foraminal penetration and canal penetration
Measured: Two months after operation, Postoperative CT scan will be evaluated for screw position.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start1 Feb 2026
- Primary completion1 Apr 2026
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for High-energy TraumaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Paticipants will undergo the operation with only one technique (either two-view fluoroscopy or three-view fluoroscopy)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonburi hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Panachol Leangtanom, Principal investigator, Chonburi hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07571798
- Sponsor's protocol ID
- ChonburiH
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pei X, Zhou W, Wang GD, Cai XH, Zheng YF, Liu XM. Comparison of Three-Dimensional Navigation-Guided Percutaneous Iliosacral Screw and Minimally Invasive Percutaneous Plate for the Treatment of Zone II Unstable Sacral Fractures. Orthop Surg. 2023 Feb;15(2):471-479. doi: 10.1111/os.13561. Epub 2022 Dec 2.
PubMed 36458444Pishnamaz M, Dienstknecht T, Hoppe B, Garving C, Lange H, Hildebrand F, Kobbe P, Pape HC. Assessment of pelvic injuries treated with ilio-sacral screws: injury severity and accuracy of screw positioning. Int Orthop. 2016 Jul;40(7):1495-501. doi: 10.1007/s00264-015-2933-1. Epub 2015 Aug 11.
PubMed 26260867Berger-Groch J, Lueers M, Rueger JM, Lehmann W, Thiesen D, Kolb JP, Hartel MJ, Grossterlinden LG. Accuracy of navigated and conventional iliosacral screw placement in B- and C-type pelvic ring fractures. Eur J Trauma Emerg Surg. 2020 Feb;46(1):107-113. doi: 10.1007/s00068-018-0990-z. Epub 2018 Jul 20.
PubMed 30030551Zarei M, Moosavi M, Saghebdoust S, Shafizadeh M, Rostami M. Percutaneous iliosacral screw insertion with only outlet and inlet fluoroscopic view for unstable pelvic ring injuries: Clinical and radiological outcomes. Surg Neurol Int. 2022 Sep 30;13:455. doi: 10.25259/SNI_616_2022. eCollection 2022.
PubMed 36324935Qoreishy M, Movahedinia M, Maleki A, Kazemi S. Safe Corridor for Sacroiliac Screw Insertion Can Be Found Quickly Without the Use of the Lateral Sacral View. Arch Bone Jt Surg. 2022 Nov;10(11):959-963. doi: 10.22038/ABJS.2022.60025.2956.
PubMed 36561220Dehkhoda F, Manafi Rasi A, Zandi R, Abedi M, Ebadi SS. Percutaneous Sacroiliac Screw Fixation: A Modified Screw Insertion Method Using Just 2 Fluoroscopy Views. Arch Bone Jt Surg. 2024;12(8):574-579. doi: 10.22038/ABJS.2024.77855.3589.
PubMed 39211565Zwingmann J, Hauschild O, Bode G, Sudkamp NP, Schmal H. Malposition and revision rates of different imaging modalities for percutaneous iliosacral screw fixation following pelvic fractures: a systematic review and meta-analysis. Arch Orthop Trauma Surg. 2013 Sep;133(9):1257-65. doi: 10.1007/s00402-013-1788-4. Epub 2013 Jun 8.
PubMed 23748798Hinsche AF, Giannoudis PV, Smith RM. Fluoroscopy-based multiplanar image guidance for insertion of sacroiliac screws. Clin Orthop Relat Res. 2002 Feb;(395):135-44. doi: 10.1097/00003086-200202000-00014.
PubMed 11937873van den Bosch EW, van Zwienen CM, van Vugt AB. Fluoroscopic positioning of sacroiliac screws in 88 patients. J Trauma. 2002 Jul;53(1):44-8. doi: 10.1097/00005373-200207000-00009.
PubMed 12131388Matta JM, Saucedo T. Internal fixation of pelvic ring fractures. Clin Orthop Relat Res. 1989 May;(242):83-97.
PubMed 2706863Florio M, Capasso L, Olivi A, Vitiello C, Leone A, Liuzza F. 3D - Navigated percutaneous screw fixation of pelvic ring injuries - a pilot study. Injury. 2020 Aug;51 Suppl 3:S28-S33. doi: 10.1016/j.injury.2020.07.025. Epub 2020 Jul 10.
PubMed 32723529Kim CH, Kim JJ, Kim JW. Percutaneous posterior transiliac plate versus iliosacral screw fixation for posterior fixation of Tile C-type pelvic fractures: a retrospective comparative study. BMC Musculoskelet Disord. 2022 Jun 16;23(1):581. doi: 10.1186/s12891-022-05536-x.
PubMed 35705948Kaiser SP, Gardner MJ, Liu J, Routt ML Jr, Morshed S. Anatomic Determinants of Sacral Dysmorphism and Implications for Safe Iliosacral Screw Placement. J Bone Joint Surg Am. 2014 Jul 16;96(14):e120. doi: 10.2106/JBJS.M.00895.
PubMed 25031382Tabaie SA, Bledsoe JG, Moed BR. Biomechanical comparison of standard iliosacral screw fixation to transsacral locked screw fixation in a type C zone II pelvic fracture model. J Orthop Trauma. 2013 Sep;27(9):521-6. doi: 10.1097/BOT.0b013e3182781102.
PubMed 23114418Liu F, Yu J, Yang H, Cai L, Chen L, Lei Q, Lei P. Iliosacral screw fixation of pelvic ring disruption with tridimensional patient-specific template guidance. Orthop Traumatol Surg Res. 2022 Apr;108(2):103210. doi: 10.1016/j.otsr.2022.103210. Epub 2022 Jan 22.
PubMed 35077898
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Difference of Two and Three Fluoroscopic Views of Sacrum for Percutaneous Sacroiliac Screw Insertion in High Energy Posterior Pelvic Ring Injured Patients, a Double-blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07571798
- Acronym / sponsor ID
- ChonburiH
- Keywords
- Sacral fracture, Fluoroscopic view, Orthopedic trauma, Percutaneous SI screw, Pelvic injury
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Chonburi hospitalOther government
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 6 May 2026 (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 goal of this clinical trial is to learn about the surgical techniques of percutaneous sacroiliac screw fixation both the two-view fluoroscopic technique (sacral inlet and outlet views) and the standard three-view fluoroscopic technique (lateral, sacral inlet, and sacral outlet views).
The main questions it aims to answer is:
- Is there any difference of the operative time, intraoperative radiation exposure time, screw malposition rate, and postoperative neurological complication rate for percutaneous pelvic screw fixation between two techniques?
Researchers will compare two surgical techniques of percutaneous sacroiliac screw fixation in high energy posterior pelvic ring injured patients.
Participants will:
- Be examined neurological status carefully before and after the operation
- Get both preoperative and postoperative CT scan
- Undergo the percutaneous sacroiliac screw(s) fixation with or without anterior plating fixation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Paticipants will undergo the operation with only one technique (either two-view fluoroscopy or three-view fluoroscopy)
| Arm | Type | Receives |
|---|---|---|
| Percutaneous SI screw insertion using two fluoroscopic views | Active comparator | Procedure: Percutaneous sacroiliac screw fixation using two or three fluoroscopic viewsPatients with posterior pelvic ring or sacral injuries resulting from high-energy trauma who required the sacroiliac screw fixation. Surgeon will insert the SI screw percutaneously using sacral inlet and sacral outlet fluoroscopic views |
| Percutaneous SI screw insertion using three fluoroscopic views | Active comparator | Procedure: Percutaneous sacroiliac screw fixation using two or three fluoroscopic viewsPatients with posterior pelvic ring or sacral injuries resulting from high-energy trauma who required the sacroiliac screw fixation. Surgeon will insert the SI screw percutaneously using lateral, sacral inlet and sacral outlet fluoroscopic views |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with traumatic posterior pelvic ring or sacral fractures indicated percutaneous screw fixation.
- Patients who are fully conscious, possess decision-making capacity, and can provide informed consent.
Key exclusion criteria (10 listed)
- Presence of severe sacral dysmorphism (sacral dysmorphic score > 70 and absence of osseous corridor)
- Concomitant diagnosis of osteoporosis or age more than 60 years
- Age under 20 years or evidence of skeletal immaturity
- Pregnancy
- Highly comminuted sacral fractures precluding accurate intraoperative assessment of the screw trajectory
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 |
|---|---|---|
| Percutaneous sacroiliac screw fixation using two or three fluoroscopic viewsSurgeon will insert the SI screw percutaneously using sacral inlet, sacral outlet fluoroscopic views with or without lateral sacral view | Procedure or surgery | Percutaneous SI screw insertion using three fluoroscopic views, Percutaneous SI screw insertion using two fluoroscopic views |
Primary outcome
Operative time
Time frame: perioperative record
Operative time in minutes that takes for insertion of guide pin of cannulated SI screw; From the time of skin incision to the final acceptable positioning of the guide pin (prior to screw insertion)
3 secondary outcomes
Radiation Exposure Time
Time frame: Perioperative record
Neurological complications by physical examinations and symptoms
Time frame: Immediate postoperative to two months after operation
Screw malposition
Time frame: Two months after operation, Postoperative CT scan will be evaluated for screw position.
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 6 May 2026.
- Background: PubMed 36458444Pei X, Zhou W, Wang GD, Cai XH, Zheng YF, Liu XM. Comparison of Three-Dimensional Navigation-Guided Percutaneous Iliosacral Screw and Minimally Invasive Percutaneous Plate for the Treatment of Zone II Unstable Sacral Fractures. Orthop Surg. 2023 Feb;15(2):471-479. doi: 10.1111/os.13561. Epub 2022 Dec 2.
- Background: PubMed 26260867Pishnamaz M, Dienstknecht T, Hoppe B, Garving C, Lange H, Hildebrand F, Kobbe P, Pape HC. Assessment of pelvic injuries treated with ilio-sacral screws: injury severity and accuracy of screw positioning. Int Orthop. 2016 Jul;40(7):1495-501. doi: 10.1007/s00264-015-2933-1. Epub 2015 Aug 11.
- Background: PubMed 30030551Berger-Groch J, Lueers M, Rueger JM, Lehmann W, Thiesen D, Kolb JP, Hartel MJ, Grossterlinden LG. Accuracy of navigated and conventional iliosacral screw placement in B- and C-type pelvic ring fractures. Eur J Trauma Emerg Surg. 2020 Feb;46(1):107-113. doi: 10.1007/s00068-018-0990-z. Epub 2018 Jul 20.
- Background: PubMed 36324935Zarei M, Moosavi M, Saghebdoust S, Shafizadeh M, Rostami M. Percutaneous iliosacral screw insertion with only outlet and inlet fluoroscopic view for unstable pelvic ring injuries: Clinical and radiological outcomes. Surg Neurol Int. 2022 Sep 30;13:455. doi: 10.25259/SNI_616_2022. eCollection 2022.
- Background: PubMed 36561220Qoreishy M, Movahedinia M, Maleki A, Kazemi S. Safe Corridor for Sacroiliac Screw Insertion Can Be Found Quickly Without the Use of the Lateral Sacral View. Arch Bone Jt Surg. 2022 Nov;10(11):959-963. doi: 10.22038/ABJS.2022.60025.2956.
- Background: PubMed 39211565Dehkhoda F, Manafi Rasi A, Zandi R, Abedi M, Ebadi SS. Percutaneous Sacroiliac Screw Fixation: A Modified Screw Insertion Method Using Just 2 Fluoroscopy Views. Arch Bone Jt Surg. 2024;12(8):574-579. doi: 10.22038/ABJS.2024.77855.3589.
- Background: PubMed 23748798Zwingmann J, Hauschild O, Bode G, Sudkamp NP, Schmal H. Malposition and revision rates of different imaging modalities for percutaneous iliosacral screw fixation following pelvic fractures: a systematic review and meta-analysis. Arch Orthop Trauma Surg. 2013 Sep;133(9):1257-65. doi: 10.1007/s00402-013-1788-4. Epub 2013 Jun 8.
- Background: PubMed 11937873Hinsche AF, Giannoudis PV, Smith RM. Fluoroscopy-based multiplanar image guidance for insertion of sacroiliac screws. Clin Orthop Relat Res. 2002 Feb;(395):135-44. doi: 10.1097/00003086-200202000-00014.
- Background: PubMed 12131388van den Bosch EW, van Zwienen CM, van Vugt AB. Fluoroscopic positioning of sacroiliac screws in 88 patients. J Trauma. 2002 Jul;53(1):44-8. doi: 10.1097/00005373-200207000-00009.
- Background: PubMed 2706863Matta JM, Saucedo T. Internal fixation of pelvic ring fractures. Clin Orthop Relat Res. 1989 May;(242):83-97.
- Background: PubMed 32723529Florio M, Capasso L, Olivi A, Vitiello C, Leone A, Liuzza F. 3D - Navigated percutaneous screw fixation of pelvic ring injuries - a pilot study. Injury. 2020 Aug;51 Suppl 3:S28-S33. doi: 10.1016/j.injury.2020.07.025. Epub 2020 Jul 10.
- Background: PubMed 35705948Kim CH, Kim JJ, Kim JW. Percutaneous posterior transiliac plate versus iliosacral screw fixation for posterior fixation of Tile C-type pelvic fractures: a retrospective comparative study. BMC Musculoskelet Disord. 2022 Jun 16;23(1):581. doi: 10.1186/s12891-022-05536-x.
Related trials for High-energy Trauma
RecruitingPhase 1/2
High-energy Human Milk Diets in the First Two Weeks After Birth to Reduce BPD in Extremely Preterm Infants
Extreme Prematurity, Enteral Nutrition
Recruiting
Bioimpedance for Ortho Trauma
Trauma Injury
Recruiting
High-Energy Laser in the Conservative Treatment of Rhizarthrosis
Thumb Osteoarthritis, Hand Injuries
Recruiting
Effects of High Intensity Laser Therapy in Muscle Injuries
Muscle Tear
Active, not recruitingPhase 4
PVI to Prevent S. Aureus SSI After Fixation of HELEF (POTENT Study)
Surgical Site Infection
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.
Panachol Leangtanom principal investigator
Chonburi hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous sacroiliac screw fixation using two or three fluoroscopic views in people with High-energy Trauma and Sacral Fractures, run by Chonburi hospital at 1 site in Thailand.
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 2 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. 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 Thailand. 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?
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?
Operative time (time frame: perioperative record). 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 NCT07571798, which also lists 15 linked publications.
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 6 May 2026.