Lumbopelvic Fixation Versus Novel Adjustable Plate for Displaced Sacral Fracture

NCT03647410 | Unknown

• 1 other identifier: RPZ2018
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Reduction Deformity of Limb

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• the incidence of complication

  1 year

Study Arms (2)

lumbopelvic fixation

sacral fractures fixed with lumbopelvic fixation

novel adjustable plate

sacral fractures fixed with novel adjustable plate

Device: lumbopelvic fixation

Interventions

lumbopelvic fixation DEVICE

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.

Also known as: novel adjustable plate

novel adjustable plate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hebei Medical University Third Hospital: lead

Study Sites (1)

Hebei Medical University Third Hospital

Shijiazhuang, Hebei, 050051, China

RECRUITING

MeSH Terms

Conditions

Ectromelia

Condition Hierarchy (Ancestors)

Limb Deformities, Congenital; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ruipeng Zhang

  Third Hospital of Hebei Medical University Department of Orthopaedic Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruipeng Zhang

CONTACT

+8615613390624; zhangruipengdoctor@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: August 27, 2018
• Study Start: June 1, 2011
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: August 27, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)