Open Versus Minimally Invasive Fixation for Unstable Sacral Fractures in Adults (NCT07534579) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Open Versus Minimally Invasive Fixation for Unstable Sacral Fractures in Adults
60 participantsStarted 2026-05
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 pat…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Majeed Pelvic Score (MPS)
Timeframe: At final clinical follow-up, with a minimum of 12 months postoperatively.