Lumbopelvic Fixation Versus Novel Adjustable Plate for Displaced Sacral Fracture

• Conditions: Reduction Deformity of Limb

• Registration Number: NCT03647410
• Lead Sponsor: Hebei Medical University Third Hospital

Brief Summary

Patients of unilaterally displaced sacral fractures fixed with lumbopelvic technique or novel adjustable plate from June 2011 to June 2017 were recruited into this study and were divided into two groups: group A (lumbopelvic fixation) and groups B (novel adjustable plate). Surgical time, intraoperative blood loss, frequency of intraoperative fluoroscopy, reduction quality, related complications were reviewed. Fracture healing was assessed by the radiographs conducted at follow-up. Functional outcome was evaluated according to the Majeed score at the final follow-up.

Detailed Description

Patients of unilateral displaced sacral fractures from June 2011 to June 2017 were recruited into this study. The inclusion criteria were as follows: 18-65 years, with normal activity ability before injury, fixed with lumbopelvic technique or novel adjustable plate, completed more than a year follow-up. The exclusion criteria were as follows: pathologic fractures, open fractures, associated with other severe injuries (traumatic brain injury), risk factors affecting bone healing (osteoporosis, smoking, and metabolic diseases) and non-completion of one-year follow-up. Surgical time, intraoperative blood loss, frequency of intraoperative fluoroscopy, related complications were reviewed. Reduction quality was assessed on the postoperative radiographs and CT scans. Functional outcome was evaluated according to the Majeed score system at the final follow-up.

Study Timeline

• Study Start: 2011-06
• Status Verified: 2018-06
• Study First Submitted: 2018-08-21
• Study First Submitted QC: 2018-08-23
• Last Update Submitted: 2018-08-23
• Study First Posted: 2018-08-27
• Last Update Posted: 2018-08-27
• Primary Completion: 2018-09
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 18-65 years, with normal activity ability before injury
• Fixed with lumbopelvic technique or novel adjustable plate
• Completed more than a year follow-up

Exclusion Criteria

• Pathologic fractures
• Open fractures
• Associated with other severe injuries (traumatic brain injury)
• Risk factors affecting bone healing (osteoporosis, smoking, and metabolic diseases)
• Non-completion of one-year follow-up

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
postoperative reduction quality of sacral fractures after different surgical techniques	1 year	maximum displacement distance of the sacral fracture in the postoperative CT scans

Secondary Outcome Measures

Name	Time	Method
the incidence of complication	1 year	the incidence of wound infection, iatrogenic injury of vessels and nerves, nonunion

Trial Locations

Locations (1)

Hebei Medical University Third Hospital; 🇨🇳 Shijiazhuang, Hebei, China