Posterior Wall Osteotomy for Old Acetabular Fracture | NCT03193840

Studies
Posterior Wall Osteotomy for Old Acetabular Fracture

NCT03193840

Sponsor

Hebei Medical University Third Hospital

Status

Unknown status

Last Update Posted

Jun 23, 2017Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Surgical Procedure, Unspecified

Interventions

posterior wall osteotomy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 12, 2017Actual

Primary Completion Date

Apr 1, 2018Estimated

Completion Date

Apr 1, 2019Estimated

First Submitted Date

Jun 11, 2017

First Submission Date that Met QC Criteria

Jun 18, 2017

First Posted Date

Jun 21, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2017

Last Update Posted Date

Jun 23, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
old acetabular fracture	Experimental	posterior wall osteotomy would be conducted for thr patient with displaced acetabular fracture without surgical treatment over three weeks.	Procedure: posterior wall osteotomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
posterior wall osteotomy	Procedure	posterior wall osteotomy is conducted through Kocher-Langenbeck approach.	old acetabular fracture

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
frecture union time	the fracture line in the radiography	4 months

Secondary Outcomes

Measure	Description	Time Frame
complication	iatrogenic neurovascular injury	1 month

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zhiyong Hou	Contact	+8618533112800		houzhiyong1234@126.com

Overall Officials

Name	Affiliation	Role
Zhiyong Hou	Third Hospital of Hebei Medical University Department of Orthopaedic Surgery	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hebei Medical University Third Hospital	Recruiting	Shijiazhuang	Hebei	050051	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided