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Posterior Wall Osteotomy for Old Acetabular Fracture (osteotomy)

Primary Purpose

Surgical Procedure, Unspecified

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
posterior wall osteotomy
Sponsored by
Hebei Medical University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgical Procedure, Unspecified focused on measuring old acetabular fracture; posterior wall osteotomy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • acetabular fracture
  • no surgical procedure has been obtained over 3 weeks
  • deformed healing
  • receive posterior wall osteotomy
  • completed more than one year follow-up

Exclusion Criteria:

  • accompanied with other fracture
  • pathological fracture
  • reject the posterior wall osteotomy

Sites / Locations

  • Hebei Medical University Third HospitalRecruiting
  • Zhiyong HouRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

old acetabular fracture

Arm Description

posterior wall osteotomy would be conducted for thr patient with displaced acetabular fracture without surgical treatment over three weeks.

Outcomes

Primary Outcome Measures

frecture union time
the fracture line in the radiography

Secondary Outcome Measures

complication
iatrogenic neurovascular injury

Full Information

First Posted
June 11, 2017
Last Updated
June 22, 2017
Sponsor
Hebei Medical University Third Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03193840
Brief Title
Posterior Wall Osteotomy for Old Acetabular Fracture
Acronym
osteotomy
Official Title
Surgical Treatment of Old Acetabular Fracture With Posterior Wall Osteotomy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 12, 2017 (Actual)
Primary Completion Date
April 1, 2018 (Anticipated)
Study Completion Date
April 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hebei Medical University Third Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Posterior wall osteotomy would be conducted to manage the old acetabular fracture. The outcome was reviewed to assess the feasibility of the surgical procedure.
Detailed Description
More and more patients with old acetabular fracture were admitted in our institution during the past years. There is little literature especially depicts the therapeutic principle of the kind of damage. Posterior wall osteotomy would be conducted to eliminate the fragments or callus from the hip joint. Then, the deformed healing acetabulum could become mobile and the reduction may be achieved. However, the surgical procedure is technique demanding and some intraoperative risk may be accompanied. Surgical time, blood loss, complication and fracture healing would be reviewed to assess the feasibility of the surgical procedure. The function outcome is evaluated with HHS score at the follow up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Procedure, Unspecified
Keywords
old acetabular fracture; posterior wall osteotomy

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
old acetabular fracture
Arm Type
Experimental
Arm Description
posterior wall osteotomy would be conducted for thr patient with displaced acetabular fracture without surgical treatment over three weeks.
Intervention Type
Procedure
Intervention Name(s)
posterior wall osteotomy
Intervention Description
posterior wall osteotomy is conducted through Kocher-Langenbeck approach.
Primary Outcome Measure Information:
Title
frecture union time
Description
the fracture line in the radiography
Time Frame
4 months
Secondary Outcome Measure Information:
Title
complication
Description
iatrogenic neurovascular injury
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: acetabular fracture no surgical procedure has been obtained over 3 weeks deformed healing receive posterior wall osteotomy completed more than one year follow-up Exclusion Criteria: accompanied with other fracture pathological fracture reject the posterior wall osteotomy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhiyong Hou
Phone
+8618533112800
Email
houzhiyong1234@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhiyong Hou
Organizational Affiliation
Third Hospital of Hebei Medical University Department of Orthopaedic Surgery
Official's Role
Study Chair
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
Email
houzhiyong1234@126.com
First Name & Middle Initial & Last Name & Degree
Ruipeng Zhang, M.D
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

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Posterior Wall Osteotomy for Old Acetabular Fracture

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