- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03026920
Pelvic and Acetabular Fracture in Old People
December 13, 2017 updated by: Hebei Medical University Third Hospital
Different Surgical Methods for Pelvic or Acetabular Fracture of Old Man
It was reported that satisfactory postoperative outcome was difficult to obtain for the pelvic or acetabular fracture in old people.
The less invasive surgical method was conducted in this study.
Then, the clinical results were compared with the patients treated using traditional methods to assess the less invasive method.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Pelvic or acetabular fractures were caused by high energy trauma, which may lead to poor prognosis for the old.
The patients over 60 years were included in this study.
The surgical procedure was conducted in two weeks.
The less invasive methods involved Stoppa approach and novel plate.
The data including surgical time, blood loss and results of follow-up were recorded.
The clinical results were compared with the patients treated using traditional methods.
Thus, the clinical outcome of Pelvic or acetabular fractures in old man was assessed.
Study Type
Interventional
Enrollment (Anticipated)
40
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
- Hebei medical university third hospital
-
-
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
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Over 60 years old Fracture involving pelvis or acetabulum Operation was conducted within 14 days Sign the consent form
Exclusion Criteria:
Presented with a pathologic acetabular fracture 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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: clinical outcome
Less invasive method was applied to pelvic or acetabular fracture of old people.
Thus, the clinical outcome of Pelvic or acetabular fractures in old man was assessed.
|
The less invasive surgical method was conducted in this study.
Then, the clinical results were compared with the patients treated using traditional methods to assess the less invasive method.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
fracture union time
Time Frame: 4 months
|
how long the fracture line disappeared postoperatively in radiograph
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
complication
Time Frame: 12 months
|
wound infection, iatrogenic injury of vessels and nerves, nonunion
|
12 months
|
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
June 1, 2016
Primary Completion (Anticipated)
December 1, 2017
Study Completion (Anticipated)
June 1, 2018
Study Registration Dates
First Submitted
January 18, 2017
First Submitted That Met QC Criteria
January 19, 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
- HZY2015
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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