Lumbopelvic Fixation Versus Novel Adjustable Plate for Displaced Sacral Fracture

NCT ID: NCT03647410

Last Updated: 2018-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2018-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Reduction Deformity of Limb

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

lumbopelvic fixation

sacral fractures fixed with lumbopelvic fixation

No interventions assigned to this group

novel adjustable plate

sacral fractures fixed with novel adjustable plate

lumbopelvic fixation

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

novel adjustable plate

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hebei Medical University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ruipeng Zhang

Role: PRINCIPAL_INVESTIGATOR

Third Hospital of Hebei Medical University Department of Orthopaedic Surgery

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hebei Medical University Third Hospital

Shijiazhuang, Hebei, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ruipeng Zhang

Role: CONTACT

+8615613390624

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yingze Zhang, M.D

Role: primary

+8613313012888

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RPZ2018

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.