Clinical trial NCT03647410: Lumbopelvic Fixation Versus Novel Adjustable Plate for Displaced Sacral Fracture
Official title: Lumbopelvic Fixation Versus Novel Adjustable Plate for Displaced Sacral Fractures: A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Reduction Deformity of Limb
Lead sponsor: Hebei Medical University Third Hospital
Sponsor class: OTHER
First posted: 2018-08-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: postoperative reduction quality of sacral fractures after different surgical techniques
timeFrame: 1 year
Secondary outcomes:
measure: the incidence of complication
timeFrame: 1 year
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: Hebei Medical University Third Hospital
state: Hebei
Study officials:
affiliation: Third Hospital of Hebei Medical University Department of Orthopaedic Surgery
name: Ruipeng Zhang
role: PRINCIPAL_INVESTIGATOR
References: