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W-Shaped Acetabular Angular Plate (WAAP) Versus Reconstruction Plate

Primary Purpose

Fracture of Posterior Wall of Acetabulum

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
W-Shaped Angular Plate
Reconstruction Plate
Sponsored by
Hebei Medical University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fracture of Posterior Wall of Acetabulum

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female aged 18 years or older(with no upper age limit)
  • Sustained a posterior acetabular wall fracture(ASIF/OTA classification 62-A1)
  • Operation was performed within 14 days after the fracture occurring

Exclusion Criteria:

  • Presented with a pathologic acetabular fracture
  • Neuropathic arthropathy,dementia and other disease processes which made postoperative compliance unreliable
  • Refused to participate
  • Patients who were unable to walk before injury

Sites / Locations

  • Hebei Medical University Third Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

WP group

RP group

Arm Description

WP group:treated with W-Shaped Angular Plate

RP group:treated with Reconstruction Plate

Outcomes

Primary Outcome Measures

Reduction quality of fracture
Based on the radiographic grade criteria developed by Matta

Secondary Outcome Measures

Surgical details
Operative duration,Fluoroscopy time,Blood loss, Blood transfusion,Any possible intraoperative complications
Early postoperative complications
Deep vein thrombosis (DVT), Skin necrosis, Infection, Loss of reduction, Arthritis,Death
Late postoperative complications
Heterotopic ossification, Chondrolysis, Avascular necrosis,Posttraumatic arthrosis
Evaluation of Clinical outcome
According to a modified Merle d'Aubigne and Postel score

Full Information

First Posted
December 20, 2014
Last Updated
August 15, 2016
Sponsor
Hebei Medical University Third Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02327949
Brief Title
W-Shaped Acetabular Angular Plate (WAAP) Versus Reconstruction Plate
Official Title
Prospective Comparison Between W-Shaped Acetabular Angular Plate (WAAP) and Reconstruction Plate for the Treatment of Posterior Acetabular Wall Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
March 2017 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether this new W-Shaped Angular Plate is more effective and more safe to operate than the traditional reconstruction plate in the treatment of the posterior wall fracture of acetabulum.
Detailed Description
The posterior acetabular wall fracture is one of the simpler acetabular fracture patterns and the most common type, accounting for approximately one quarter of all acetabular fractures. Most patients achieve excellent outcomes after anatomical reduction and rigid internal fixation with standard screws and buttress plates.However,it is well known that the reconstruction plate need remould in the surgery. So it does not only lead to the extension of operation time, but also cause poor attach of acetabular posterior wall. Moreover, the angulation of the screw placement for the holes of the reconstruction plate in the danger zone was determined with only caution. The intraoperative fluoroscopy was employed frequently to help determine the periacetabular screw location. If the operator lack of experience, intraarticular screw penetration and prolonged operative duration is inevitable. The investigators now introduce a new type of internal fixation device of acetabular posterior wall fracture that improve the shortcomings of existing technology.The plate itself can be thought to consist of three regions: the iliac region, the danger zone region, and the ischial tuberosity region. The organization of these regions causes the plate to resemble the English alphabet letter ''W''.The contour and zygomorphy of the W-shaped plate matched the surface of the posterior column of the acetabulum. There are two rows of drill holes in the danger zone region. A special safe-angled drilling guide was used to assist in the operation. A retrospective study has been indicated that this kind of new plate produce good results. This device may help to avoid intraarticular screw penetration and reduce operative duration and blood loss. The device further provides a stable fixation of the posterior wall that is amenable to early range of motion and weight bearing postoperatively, and results in a good clinical outcome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture of Posterior Wall of Acetabulum

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
WP group
Arm Type
Experimental
Arm Description
WP group:treated with W-Shaped Angular Plate
Arm Title
RP group
Arm Type
Active Comparator
Arm Description
RP group:treated with Reconstruction Plate
Intervention Type
Device
Intervention Name(s)
W-Shaped Angular Plate
Intervention Description
Treatment of posterior wall fracture of the acetabulum with a W-Shaped Angular Plate
Intervention Type
Device
Intervention Name(s)
Reconstruction Plate
Intervention Description
Treatment of posterior wall fracture of the acetabulum with a Reconstruction Plate
Primary Outcome Measure Information:
Title
Reduction quality of fracture
Description
Based on the radiographic grade criteria developed by Matta
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Surgical details
Description
Operative duration,Fluoroscopy time,Blood loss, Blood transfusion,Any possible intraoperative complications
Time Frame
Intraoperative
Title
Early postoperative complications
Description
Deep vein thrombosis (DVT), Skin necrosis, Infection, Loss of reduction, Arthritis,Death
Time Frame
One month
Title
Late postoperative complications
Description
Heterotopic ossification, Chondrolysis, Avascular necrosis,Posttraumatic arthrosis
Time Frame
One year
Title
Evaluation of Clinical outcome
Description
According to a modified Merle d'Aubigne and Postel score
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female aged 18 years or older(with no upper age limit) Sustained a posterior acetabular wall fracture(ASIF/OTA classification 62-A1) Operation was performed within 14 days after the fracture occurring Exclusion Criteria: Presented with a pathologic acetabular fracture Neuropathic arthropathy,dementia and other disease processes which made postoperative compliance unreliable Refused to participate Patients who were unable to walk before injury
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhiyong Hou, MD
Organizational Affiliation
Hebei Medical University Third Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Shuai Shang, MM
Organizational Affiliation
Hebei Medical University Third Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hebei Medical University Third Hospital
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China

12. IPD Sharing Statement

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W-Shaped Acetabular Angular Plate (WAAP) Versus Reconstruction Plate

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