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

Prospective Comparison Between W-Shaped Acetabular Angular Plate (WAAP) and Reconstruction Plate for the Treatment of Posterior Acetabular Wall Fracture

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.

Study Overview

• Status: Unknown
• Conditions: Fracture of Posterior Wall of Acetabulum
• Intervention / Treatment: Device: W-Shaped Angular Plate; Device: Reconstruction Plate

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • Hebei medical university third hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WP group; WP group:treated with W-Shaped Angular Plate	Device: W-Shaped Angular Plate; Treatment of posterior wall fracture of the acetabulum with a W-Shaped Angular Plate
Active Comparator: RP group; RP group:treated with Reconstruction Plate	Device: Reconstruction Plate; Treatment of posterior wall fracture of the acetabulum with a Reconstruction Plate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction quality of fracture	Based on the radiographic grade criteria developed by Matta	Six months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hebei Medical University Third Hospital
• Investigators: Study Chair: Zhiyong Hou, MD, Hebei medical university third hospital; Principal Investigator: Shuai Shang, MM, Hebei medical university third hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Anticipated): March 1, 2017
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: December 20, 2014
• First Submitted That Met QC Criteria: December 25, 2014
• First Posted (Estimate): December 31, 2014

Study Record Updates

• Last Update Posted (Estimate): August 17, 2016
• Last Update Submitted That Met QC Criteria: August 15, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: HZY-0001