NCT02327949

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 31, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

August 17, 2016

Status Verified

August 1, 2016

Enrollment Period

2.2 years

First QC Date

December 20, 2014

Last Update Submit

August 15, 2016

Conditions

Fracture of Posterior Wall of Acetabulum

Outcome Measures

Primary Outcomes (1)

  • Reduction quality of fracture

    Based on the radiographic grade criteria developed by Matta

    Six months

Secondary Outcomes (4)

  • Surgical details

    Intraoperative

  • Early postoperative complications

    One month

  • Late postoperative complications

    One year

  • Evaluation of Clinical outcome

    One year

Study Arms (2)

WP group

EXPERIMENTAL

WP group:treated with W-Shaped Angular Plate

Device: W-Shaped Angular Plate

RP group

ACTIVE COMPARATOR

RP group:treated with Reconstruction Plate

Device: Reconstruction Plate

Interventions

W-Shaped Angular PlateDEVICE

Treatment of posterior wall fracture of the acetabulum with a W-Shaped Angular Plate

WP group
Reconstruction PlateDEVICE

Treatment of posterior wall fracture of the acetabulum with a Reconstruction Plate

RP group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hebei Medical University Third Hospital

Shijiazhuang, Hebei, 050000, China

Location

MeSH Terms

Interventions

Mandibular Reconstruction

Intervention Hierarchy (Ancestors)

Orthognathic Surgical ProceduresOral Surgical ProceduresDentistry

Study Officials

  • Zhiyong Hou, MD

    Hebei Medical University Third Hospital

    STUDY CHAIR

  • Shuai Shang, MM

    Hebei Medical University Third Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director of Orthopaedic Center,MD

Study Record Dates

First Submitted

December 20, 2014

First Posted

December 31, 2014

Study Start

December 1, 2014

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

August 17, 2016

Record last verified: 2016-08

Locations

CN(1)