Lumbopelvic Fixation Versus Novel Adjustable Plate for Displaced Sacral Fracture

Reduction Deformity of Limb Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03647410
• Other study ID #: RPZ2018
• Status: Recruiting
• Start date: June 2011
• Est. completion date: September 2018

Study information

• Verified date: June 2018
• Source: Hebei Medical University Third Hospital
• Contact: Ruipeng Zhang
• Phone: +8615613390624
• Email: zhangruipengdoctor[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Reduction Deformity of Limb

Intervention

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.

Locations

Country	Name	City	State
China	Hebei Medical University Third Hospital	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	the incidence of complication	the incidence of wound infection, iatrogenic injury of vessels and nerves, nonunion	1 year