Changeflow GovPing Pharma & Healthcare Sacral Fracture Fixation Trial Compares Open, M...
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Sacral Fracture Fixation Trial Compares Open, Minimally Invasive Surgical Approaches

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Summary

NIH's ClinicalTrials.gov has registered observational study NCT07534579 comparing open versus minimally invasive lumbopelvic fixation for unstable sacral fractures in adults. The retrospective study will review medical records and imaging of patients treated between January 2016 and December 2024 to evaluate physical function using the Majeed Pelvic Score, bone healing, surgical complications including wound infections and hardware failures, and clinical nerve function recovery.

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What changed

This ClinicalTrials.gov registry entry documents an observational study (NCT07534579) comparing open surgical versus minimally invasive approaches for lumbopelvic fixation in treating unstable sacral fractures. The retrospective study will analyze medical records and imaging from patients treated over an eight-year period (January 2016 to December 2024), evaluating outcomes including physical function (Majeed Pelvic Score), bone healing, complication rates, and nerve function recovery.\n\nHealthcare providers and clinical investigators involved in orthopedic trauma or spinal surgery may find this registry relevant for understanding emerging comparative evidence on surgical fixation techniques. The study does not create compliance obligations but provides a framework for evidence collection on sacral fracture treatment approaches.

Archived snapshot

Apr 16, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

Open Versus Minimally Invasive Fixation for Unstable Sacral Fractures in Adults

Observational NCT07534579 Kind: OBSERVATIONAL Apr 16, 2026

Abstract

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 p...

Conditions: Sacral Fractures, Traumatic Unstable Sacral Fractures, Spinopelvic Dissociation, Pelvic Ring Injuries

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Last updated

Classification

Agency
NIH
Published
April 16th, 2026
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07534579
Docket
NCT07534579

Who this affects

Applies to
Healthcare providers Clinical investigators
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trial registration Surgical outcome research
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Medical Devices

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