Sacral FracturesNCT07534579
Open Versus Minimally Invasive Fixation for Unstable Sacral Fractures in Adults
An observational study of Sacral Fractures and Traumatic Unstable Sacral Fractures, run by Assiut University.
Trial summary
Severe injuries to the lower spine and pelvis, known as traumatic unstable sacral fractures, are complex injuries that often require surgery to stabilize the bones and prevent long-term disability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sacral Fractures, Traumatic Unstable Sacral Fractures, Spinopelvic Dissociation
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Jun 2027
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: The study population consists of adult patients ($\ge$ 18 years) treated at the Department of Orthopedic Surgery and Traumatology at Assiut University. Patients must have a confirmed diagnosis of a traumatic, unstable sacral fracture (including Denis Zones I-III with instability, spinopelvic dissociation, or AO/OTA Type C injuries). All included subjects were operated on using either open or minimally invasive lumbopelvic fixation between January 2016 and December 2024. Furthermore, participants must have adequate medical records with a minimum of 12 months of postoperative clinical follow-up.
Who may be able to join
- Adult patients aged 18 years or older at the time of injury and surgery.
- Confirmed diagnosis of a traumatic, unstable sacral fracture, including: Denis Zone I, II, or III fractures with instability; Spinopelvic dissociation (U-type / H-type sacral fractures); AO/OTA Type C pelvic ring injuries involving the sacrum.
- Operated on using lumbopelvic fixation (open or minimally invasive technique) within the study period (2016-2024).
- Availability of adequate and complete medical records, including: Preoperative and postoperative imaging (X-ray and/or CT scan), and operative notes and surgical logs.
- Minimum clinical follow-up of 12 months postoperatively.
Who cannot join
- Pathological fractures (e.g., fractures secondary to primary or metastatic malignancy, osteoporotic insufficiency fractures).
- Patients managed conservatively or with alternative fixation strategies that do not include lumbopelvic instrumentation (e.g., isolated iliosacral screw fixation, anterior ring fixation alone).
- Severe polytrauma resulting in in-hospital mortality prior to the minimum required follow-up period.
- History of previous pelvic, sacral, or lumbosacral spine surgery prior to the index trauma.
- Incomplete medical records or inadequate radiological follow-up data preventing accurate assessment of outcomes.
- Patients with pre-existing neuromuscular disorders or spinal pathology that would confound neurological or functional outcome assessment.
- Pregnant patients at the time of injury
About this study
Official title: Open Versus Minimally Invasive Lumbopelvic Fixation in the Management of Traumatic Unstable Sacral Fractures in Adults: A Retrospective Cohort Study
Severe injuries to the lower spine and pelvis, known as traumatic unstable sacral fractures, are complex injuries that often require surgery to stabilize the bones and prevent long-term disability. A standard surgical treatment is lumbopelvic fixation, which uses metal screws and rods to connect the lower spine to the pelvic bones. This procedure can be performed using a traditional open surgical approach with a larger incision, or a minimally invasive approach using smaller incisions.
While both methods are used to effectively stabilize the fracture, there is a need for more comprehensive data comparing which approach provides the best overall recovery with the fewest complications.
Read more
The purpose of this retrospective study is to compare the long-term outcomes of adult patients who underwent open lumbopelvic fixation versus those who had minimally invasive lumbopelvic fixation. Researchers will review the medical records and imaging of patients treated between January 2016 and December 2024.
The main goal of the study is to evaluate physical function and recovery using a standardized assessment tool called the Majeed Pelvic Score. Additionally, the study will compare the two surgical groups to look at:
- Bone healing: How well the bones aligned and healed over time.
- Surgical complications: Rates of wound infections, skin issues, or hardware failures (like broken screws).
- Clinical recovery: Improvement in nerve function (for those who had pre-existing deficits) and post-surgery back pain levels.
- Quality of life: How quickly patients were able to return to work and perform their jobs efficiently.
- Secondary surgeries: The need for any additional operations following the initial fix.
By comparing these two approaches comprehensively, researchers hope to help surgeons identify the optimal surgical method tailored to a patient's specific fracture characteristics.
Read the detailed description
Traumatic unstable sacral fractures are challenging high-energy pelvic injuries with significant implications for structural integrity and neurological function. While traditional open lumbopelvic fixation (O-LPF) provides excellent biomechanical stability and allows for direct neural decompression, it requires an extensile posterior approach associated with significant perioperative morbidity, including deep surgical site infection rates historically ranging from 16% to 26%. Minimally invasive or percutaneous lumbopelvic fixation (MIS-LPF) was developed to mitigate these approach-related complications, though it permits only indirect neural decompression.
Despite emerging evidence favoring MIS techniques for reduced blood loss and infection rates, most published series remain small, retrospective, and heterogeneous. This study aims to provide a comprehensive, multi-dimensional comparison of open versus minimally invasive lumbopelvic fixation specifically in adult patients with traumatic unstable sacral fractures.
This is a retrospective, comparative cohort study conducted at the Department of Orthopedic Surgery and Traumatology at Assiut University. Data will be systematically extracted by two independent investigators from electronic medical records, surgical operative logs, and PACS digital imaging systems for qualifying index surgeries performed between January 2016 and December 2024. A standardized data extraction sheet will be utilized to minimize observer bias, and all data will be de-identified prior to analysis.
Researchers will collect comprehensive data points across several domains:
- Baseline and Injury Characteristics: Demographics, comorbidities, mechanism of injury, and precise fracture classifications including Denis Zones, Roy-Camille, and AO/OTA.
- Surgical and Perioperative Details: Surgical technique utilized, operative time, estimated blood loss, specific implant details, use of intraoperative imaging, and length of hospital/ICU stay.
- Clinical and Radiological Outcomes: Neurological status documented via the Gibbons Neurological Grading Scale, quality of fracture reduction assessed via Matta and Tornetta criteria, time to radiographic union, and postoperative pain levels via Visual Analog Scale (VAS).
- Complications: Incidence of surgical site infections (superficial and deep), wound dehiscence, implant failure, thromboembolic events, and the necessity and timing of secondary reoperations.
- Conditions
- Sacral Fractures, Traumatic Unstable Sacral Fractures, Spinopelvic Dissociation, Pelvic Ring Injuries
- Keywords
- Lumbopelvic Fixation (LPF), Minimally Invasive Surgery (MIS), Percutaneous Lumbopelvic Fixation, Open Lumbopelvic Fixation, Sacral Laminectomy, Majeed Pelvic Score, Denis Classification, Roy-Camille Classification, Matta and Tornetta Criteria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Open Lumbopelvic Fixation (O-LPF) | Adult patients with traumatic unstable sacral fractures who were managed surgically using an open lumbopelvic fixation technique. | |
| Group B: Minimally Invasive Lumbopelvic Fixation (MIS-LPF) | Adult patients with traumatic unstable sacral fractures who were managed surgically using a minimally invasive or percutaneous lumbopelvic fixation technique. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Majeed Pelvic Score (MPS)
Functional outcome will be assessed using the Majeed Pelvic Score (MPS). The MPS is a validated 100-point scoring system evaluating five parameters: pain (30 points), work capacity (20 points), ability to sit (10 points), sexual intercourse (4 points), and standing/walking (36 points). Higher scores indicate better functional recovery, with total scores graded as: Excellent (85 or higher), Good (70 to 84), Fair (55 to 69), or Poor (less than 55).
Measured: At final clinical follow-up, with a minimum of 12 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacral FracturesStudies 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
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerolos Atef Alfy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534579
- Sponsor's protocol ID
- Open vs MIS Sacral Fixation
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Versus Minimally Invasive Lumbopelvic Fixation in the Management of Traumatic Unstable Sacral Fractures in Adults: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07534579
- Acronym / sponsor ID
- Open vs MIS Sacral Fixation
- Conditions
- Sacral Fractures, Traumatic Unstable Sacral Fractures, Spinopelvic Dissociation, Pelvic Ring Injuries
- Keywords
- Lumbopelvic Fixation (LPF), Minimally Invasive Surgery (MIS), Percutaneous Lumbopelvic Fixation, Open Lumbopelvic Fixation, Sacral Laminectomy, Majeed Pelvic Score, Denis Classification, Roy-Camille Classification
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 16 Apr 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.
Severe injuries to the lower spine and pelvis, known as traumatic unstable sacral fractures, are complex injuries that often require surgery to stabilize the bones and prevent long-term disability. A standard surgical treatment is lumbopelvic fixation, which uses metal screws and rods to connect the lower spine to the pelvic bones. This procedure can be performed using a traditional open surgical approach with a larger incision, or a minimally invasive approach using smaller incisions.
While both methods are used to effectively stabilize the fracture, there is a need for more comprehensive data comparing which approach provides the best overall recovery with the fewest complications.
The purpose of this retrospective study is to compare the long-term outcomes of adult patients who underwent open lumbopelvic fixation versus those who had minimally invasive lumbopelvic fixation. Researchers will review the medical records and imaging of patients treated between January 2016 and December 2024.
The main goal of the study is to evaluate physical function and recovery using a standardized assessment tool called the Majeed Pelvic Score. Additionally, the study will compare the two surgical groups to look at:
- Bone healing: How well the bones aligned and healed over time.
- Surgical complications: Rates of wound infections, skin issues, or hardware failures (like broken screws).
- Clinical recovery: Improvement in nerve function (for those who had pre-existing deficits) and post-surgery back pain levels.
- Quality of life: How quickly patients were able to return to work and perform their jobs efficiently.
- Secondary surgeries: The need for any additional operations following the initial fix.
By comparing these two approaches comprehensively, researchers hope to help surgeons identify the optimal surgical method tailored to a patient's specific fracture characteristics.
Detailed description
Traumatic unstable sacral fractures are challenging high-energy pelvic injuries with significant implications for structural integrity and neurological function. While traditional open lumbopelvic fixation (O-LPF) provides excellent biomechanical stability and allows for direct neural decompression, it requires an extensile posterior approach associated with significant perioperative morbidity, including deep surgical site infection rates historically ranging from 16% to 26%. Minimally invasive or percutaneous lumbopelvic fixation (MIS-LPF) was developed to mitigate these approach-related complications, though it permits only indirect neural decompression.
Despite emerging evidence favoring MIS techniques for reduced blood loss and infection rates, most published series remain small, retrospective, and heterogeneous. This study aims to provide a comprehensive, multi-dimensional comparison of open versus minimally invasive lumbopelvic fixation specifically in adult patients with traumatic unstable sacral fractures.
This is a retrospective, comparative cohort study conducted at the Department of Orthopedic Surgery and Traumatology at Assiut University. Data will be systematically extracted by two independent investigators from electronic medical records, surgical operative logs, and PACS digital imaging systems for qualifying index surgeries performed between January 2016 and December 2024. A standardized data extraction sheet will be utilized to minimize observer bias, and all data will be de-identified prior to analysis.
Researchers will collect comprehensive data points across several domains:
- Baseline and Injury Characteristics: Demographics, comorbidities, mechanism of injury, and precise fracture classifications including Denis Zones, Roy-Camille, and AO/OTA.
- Surgical and Perioperative Details: Surgical technique utilized, operative time, estimated blood loss, specific implant details, use of intraoperative imaging, and length of hospital/ICU stay.
- Clinical and Radiological Outcomes: Neurological status documented via the Gibbons Neurological Grading Scale, quality of fracture reduction assessed via Matta and Tornetta criteria, time to radiographic union, and postoperative pain levels via Visual Analog Scale (VAS).
- Complications: Incidence of surgical site infections (superficial and deep), wound dehiscence, implant failure, thromboembolic events, and the necessity and timing of secondary reoperations.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Open Lumbopelvic Fixation (O-LPF) | – | –Adult patients with traumatic unstable sacral fractures who were managed surgically using an open lumbopelvic fixation technique. |
| Group B: Minimally Invasive Lumbopelvic Fixation (MIS-LPF) | – | –Adult patients with traumatic unstable sacral fractures who were managed surgically using a minimally invasive or percutaneous lumbopelvic fixation technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients ($\ge$ 18 years) treated at the Department of Orthopedic Surgery and Traumatology at Assiut University. Patients must have a confirmed diagnosis of a traumatic, unstable sacral fracture (including Denis Zones I-III with instability, spinopelvic dissociation, or AO/OTA Type C injuries). All included subjects were operated on using either open or minimally invasive lumbopelvic fixation between January 2016 and December 2024. Furthermore, participants must have adequate medical records with a minimum of 12 months of postoperative clinical follow-up.
Key inclusion criteria (5 listed)
- Adult patients aged 18 years or older at the time of injury and surgery.
- Confirmed diagnosis of a traumatic, unstable sacral fracture, including: Denis Zone I, II, or III fractures with instability; Spinopelvic dissociation (U-type / H-type sacral fractures); AO/OTA Type C pelvic ring injuries involving the sacrum.
- Operated on using lumbopelvic fixation (open or minimally invasive technique) within the study period (2016-2024).
- Availability of adequate and complete medical records, including: Preoperative and postoperative imaging (X-ray and/or CT scan), and operative notes and surgical logs.
- Minimum clinical follow-up of 12 months postoperatively.
Key exclusion criteria (7 listed)
- Pathological fractures (e.g., fractures secondary to primary or metastatic malignancy, osteoporotic insufficiency fractures).
- Patients managed conservatively or with alternative fixation strategies that do not include lumbopelvic instrumentation (e.g., isolated iliosacral screw fixation, anterior ring fixation alone).
- Severe polytrauma resulting in in-hospital mortality prior to the minimum required follow-up period.
- History of previous pelvic, sacral, or lumbosacral spine surgery prior to the index trauma.
- Incomplete medical records or inadequate radiological follow-up data preventing accurate assessment of outcomes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Majeed Pelvic Score (MPS)
Time frame: At final clinical follow-up, with a minimum of 12 months postoperatively.
Functional outcome will be assessed using the Majeed Pelvic Score (MPS). The MPS is a validated 100-point scoring system evaluating five parameters: pain (30 points), work capacity (20 points), ability to sit (10 points), sexual intercourse (4 points), and standing/walking (36 points). Higher scores indicate better functional recovery, with total scores graded as: Excellent (85 or higher), Good (70 to 84), Fair (55 to 69), or Poor (less than 55).
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 16 Apr 2026.
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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.
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 Sacral Fractures and Traumatic Unstable Sacral Fractures, 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 7 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: opening soon, as of the sponsor's last update on 16 Apr 2026. 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?
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?
Majeed Pelvic Score (MPS) (time frame: At final clinical follow-up, with a minimum of 12 months postoperatively.). 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 16 Apr 2026.