Novel Quadrilateral Surface Plate for Acetabular Fracture

December 13, 2017 updated by: Hebei Medical University Third Hospital

Randomized Trails of Different Fixations for Acetabular Fracture Involving Quadrilateral Surface

The novel plate could be used to manage acetabular fractures involving quadrilateral surface and posterior column, which may lower the intraoperative blood loss and reduce complication rate.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Stoppa approach was more minimally invasive than ilioinguinal approach for pelvic and acetabular fractures. Then, Stoppa approach was widely used clinically. For the fragments involving quadrilateral surface, the Kocher-Langenbeck approach was added because the fixation of posterior fragments could not be obtained with reconstruction plate through single Stoppa approach. Novel quadrilateral surface plate was used in this study to examine its fixed role for posterior fragments. Functional outcome and complication were recorded to compare with the results treated with reconstruction plate. If good results were obtained for the patients fixed with quadrilateral surface plate, it was meaningful to popularize the fixed method.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hebei
      • Shijiazhuang, Hebei, China, 050051
        • Recruiting
        • Zhiyong Hou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Over 18 years old
  • Fracture involving quadrilateral surface
  • Operation was conducted within 14 days
  • Fixed with quadrilateral surface plate through Stoppa approach

Exclusion Criteria:

  • Presented with a pathologic acetabular fracture
  • Neuropathic arthropathy,dementia and other disease processes which made postoperative compliance unreliable
  • Refused to participate
  • Follow-up insufficient 12 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: quadrilateral surface plate
The fragments of the acetabulum were fixed with novel quadrilateral surface plate through Stoppa approach.
Procedure: quadrilateral surface plate
Both anterior and posterior approaches were always conducted to manage the fragments of quadrilateral surface. Novel quadrilateral surface plate was used in this study to examine whether the fragments could be fixed through single Stoppa approach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fracture healing time
Time Frame: 4 months
fracture line disappeared in the radiograph
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complication
Time Frame: 1 month
wound infection, iatrogenic injury of vessels and nerves, nonunion
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hebei Medical University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2015

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

March 1, 2018

Study Registration Dates

First Submitted

January 12, 2017

First Submitted That Met QC Criteria

January 18, 2017

First Posted (ESTIMATE)

January 20, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 15, 2017

Last Update Submitted That Met QC Criteria

December 13, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HZY2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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