- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03026868
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
-
-
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.
|
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.
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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