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Novel Quadrilateral Surface Plate for Acetabular Fracture

NCT ID: NCT03026868

Last Updated: 2017-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2018-03-31

Brief Summary

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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

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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.

Conditions

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Fracture Dislocation

Keywords

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acetabular quadrilateral surface plate

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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quadrilateral surface plate

The fragments of the acetabulum were fixed with novel quadrilateral surface plate through Stoppa approach.

Group Type EXPERIMENTAL

quadrilateral surface plate

Intervention Type PROCEDURE

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.

Interventions

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quadrilateral surface plate

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hebei Medical University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ruipeng Zhang, M.D

Role: PRINCIPAL_INVESTIGATOR

Third Hospital of Hebei Medical University Department of Orthopaedic Surgery

Locations

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Zhiyong Hou

Shijiazhuang, Hebei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhiyong Hou, M.D

Role: CONTACT

Phone: +8618533112800

Email: [email protected]

Facility Contacts

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Zhiyong Hou, M.D

Role: primary

Other Identifiers

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HZY2016

Identifier Type: -

Identifier Source: org_study_id