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Pelvic and Acetabular Fracture in Old People

Primary Purpose

Fracture Dislocation

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

less invasive method

About this trial

This is an interventional treatment trial for Fracture Dislocation focused on measuring Fracture, outcome, pelvic, acetabular

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Hebei Medical University Third HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

clinical outcome

Arm Description

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.

Outcomes

Primary Outcome Measures

fracture union time

how long the fracture line disappeared postoperatively in radiograph

Secondary Outcome Measures

complication

wound infection, iatrogenic injury of vessels and nerves, nonunion

Full Information

NCT ID

NCT03026920

First Posted

January 18, 2017

Last Updated

December 13, 2017

Sponsor

Hebei Medical University Third Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03026920

Brief Title

Pelvic and Acetabular Fracture in Old People

Official Title

Different Surgical Methods for Pelvic or Acetabular Fracture of Old Man

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Unknown status

Study Start Date

June 2016 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

June 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

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fracture Dislocation

Keywords

Fracture, outcome, pelvic, acetabular

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

clinical outcome

Arm Type

Experimental

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

less invasive method

Intervention Description

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.

Primary Outcome Measure Information:

Title

fracture union time

Description

how long the fracture line disappeared postoperatively in radiograph

Time Frame

4 months

Secondary Outcome Measure Information:

Title

complication

Description

wound infection, iatrogenic injury of vessels and nerves, nonunion

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zhiyong Hou, M.D

Phone

+8618533112800

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

Hebei Medical University Third Hospital

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

houzhiyong1234@126.com

First Name & Middle Initial & Last Name & Degree

Ruipeng Zhang, M.D

12. IPD Sharing Statement

Plan to Share IPD

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Pelvic and Acetabular Fracture in Old People

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