Lumbopelvic Fixation Versus Novel Adjustable Plate for Displaced Sacral Fracture

Lumbopelvic Fixation Versus Novel Adjustable Plate for Displaced Sacral Fractures: A Retrospective Cohort Study

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.

Study Overview

• Status: Unknown
• Conditions: Reduction Deformity of Limb
• Intervention / Treatment: Device: lumbopelvic fixation

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 Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Ruipeng Zhang; Phone Number: +8615613390624; Email: zhangruipengdoctor@126.com

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China, 050051
      • Recruiting
      • Hebei Medical University Third Hospital
      • Contact: Yingze Zhang, M.D; Phone Number: +8613313012888; Email: yzzhangdr@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
lumbopelvic fixation; sacral fractures fixed with lumbopelvic fixation
novel adjustable plate; sacral fractures fixed with novel adjustable plate	Device: lumbopelvic fixation; Sacral fractures fixed with lumbopelvic fixation or novel adjustable plate were divided into two groups. Surgical time, intraoperative blood loss, frequency of intraoperative fluoroscopy, reduction quality, related complications, and functional outcome were reviewed.; Other Names: novel adjustable plate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative reduction quality of sacral fractures after different surgical techniques	maximum displacement distance of the sacral fracture in the postoperative CT scans	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the incidence of complication	the incidence of wound infection, iatrogenic injury of vessels and nerves, nonunion	1 year

Collaborators and Investigators

• Sponsor: Hebei Medical University Third Hospital
• Investigators: Principal Investigator: Ruipeng Zhang, Third Hospital of Hebei Medical University Department of Orthopaedic Surgery

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2011
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: August 21, 2018
• First Submitted That Met QC Criteria: August 23, 2018
• First Posted (Actual): August 27, 2018

Study Record Updates

• Last Update Posted (Actual): August 27, 2018
• Last Update Submitted That Met QC Criteria: August 23, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: RPZ2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No