Novel Quadrilateral Surface Plate for Acetabular Fracture
Primary Purpose
Fracture Dislocation
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
quadrilateral surface plate
Sponsored by
About this trial
This is an interventional treatment trial for Fracture Dislocation focused on measuring acetabular, quadrilateral surface plate
Eligibility Criteria
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
Sites / Locations
- Zhiyong HouRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
quadrilateral surface plate
Arm Description
The fragments of the acetabulum were fixed with novel quadrilateral surface plate through Stoppa approach.
Outcomes
Primary Outcome Measures
fracture healing time
fracture line disappeared in the radiograph
Secondary Outcome Measures
complication
wound infection, iatrogenic injury of vessels and nerves, nonunion
Full Information
NCT ID
NCT03026868
First Posted
January 12, 2017
Last Updated
December 13, 2017
Sponsor
Hebei Medical University Third Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03026868
Brief Title
Novel Quadrilateral Surface Plate for Acetabular Fracture
Official Title
Randomized Trails of Different Fixations for Acetabular Fracture Involving Quadrilateral Surface
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (Actual)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
March 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hebei Medical University Third Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture Dislocation
Keywords
acetabular, quadrilateral surface plate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
quadrilateral surface plate
Arm Type
Experimental
Arm Description
The fragments of the acetabulum were fixed with novel quadrilateral surface plate through Stoppa approach.
Intervention Type
Procedure
Intervention Name(s)
quadrilateral surface plate
Intervention Description
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.
Primary Outcome Measure Information:
Title
fracture healing time
Description
fracture line disappeared in the radiograph
Time Frame
4 months
Secondary Outcome Measure Information:
Title
complication
Description
wound infection, iatrogenic injury of vessels and nerves, nonunion
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhiyong Hou, M.D
Phone
+8618533112800
Email
houzhiyong1234@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruipeng Zhang, M.D
Organizational Affiliation
Third Hospital of Hebei Medical University Department of Orthopaedic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhiyong Hou
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050051
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiyong Hou, M.D
Phone
+8618533112800
Email
houzhiyong1234@126.com
First Name & Middle Initial & Last Name & Degree
Ruipeng Zhang, M.D
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Novel Quadrilateral Surface Plate for Acetabular Fracture
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