Open Versus Minimally Invasive Fixation for Unstable Sacral Fractures in Adults

NCT07534579 | Not Yet Recruiting

• 1 other identifier: Open vs MIS Sacral Fixation
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• 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).

  At final clinical follow-up, with a minimum of 12 months postoperatively.

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Orthopedic Surgery Department, Assiut University

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 16, 2026
• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04