NCT01437150

Brief Summary

The purpose of this study is to determine whether this new anatomical locking plate is more effective and easy to operate than other plate in the treatment of acetabular posterior wall fracture.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 1, 2011

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 20, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

February 6, 2015

Status Verified

February 1, 2015

Enrollment Period

3.4 years

First QC Date

September 1, 2011

Last Update Submit

February 4, 2015

Conditions

Fracture of Acetabulum

Keywords

surgeryfixationbone plate

Outcome Measures

Primary Outcomes (1)

  • Bone healing condition

    Bone healing condition was checked by radiological examination.

    six months

Secondary Outcomes (3)

  • Rates of revision surgery

    one year

  • Patient quality of life

    one year

  • Complications

    one year

Study Arms (2)

Simple posterior wall fracture

EXPERIMENTAL

Simple posterior wall fracture means the fracture was only occurred in the posterior wall of acetabular.

Device: Anatomical locking plateProcedure: The Reconstructive Plate

Complex posterior wall fracture

EXPERIMENTAL

Complex posterior wall fracture means the fracture was not only occurred in the posterior wall of acetabular, but also occurred in other part of acetabular.

Device: Anatomical locking plateProcedure: The Reconstructive Plate

Interventions

Anatomical locking plateDEVICE

This is a new fixation treat for acetabular posterior wall fracture.

Also known as: WEIGAO ORTHOPAEDIC DEVICE CO.LTD., ZL200920105202.7
Complex posterior wall fractureSimple posterior wall fracture
The Reconstructive PlatePROCEDURE

Reconstructive plate was used very common in treatment of acetabular fracture.

Also known as: The Reconstructive Plate System
Complex posterior wall fractureSimple posterior wall fracture

Eligibility Criteria

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

You may qualify if:

  • Adult men or women aged 18 years and older (with no upper age limit).
  • Fracture of the acetabular posterior wall fracture confirmed with either anteroposterior and lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI).
  • Operative treatment of fractures within 14 days of presenting to the emergency room.
  • Patient was ambulatory prior to fracture, though they may have used an aid such as a cane or a walker.
  • Anticipated medical optimalization for operation.
  • Provision of informed consent by patient or legal guardian.
  • No other major trauma.

You may not qualify if:

  • Refuse to participate.
  • Patients not suitable for internal fixation (i.e., severe osteoarthritis, rheumatoid arthritis, or pathologic fracture).
  • Associated major injuries of the lower extremity (i.e., ipsilateral or contralateral fractures of the foot, ankle, tibia, fibula, knee, or femur; dislocations of the ankle, knee, or hip; or femoral head defects or fracture).
  • Retained hardware around the affected acetabular.
  • Infection around the acetabular (i.e., soft tissue or bone).
  • Patients with disorders of bone metabolism except osteoporosis (i.e., Paget's disease, renal osteodystrophy, osteomalacia).
  • Moderate or severe cognitively impaired patients (i.e., Six Item Screener with 3 or more errors).
  • Patients with Parkinson's disease (or dementia) severe enough to increase the likelihood of falling or severe enough to compromise rehabilitation.
  • Likely problems, in the judgment of the investigators, with maintaining follow-up. We will, for example, exclude patients with no fixed address, those who report a plan to move out of town in the next year, or intellectually challenged patients without adequate family support.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopedics department; The General Hospital of the People's Liberation Army

Beijing, Beijing Municipality, 100853, China

Location

Study Officials

  • Tang Peifu, Dr.

    Chinese PLA General Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief, Professor

Study Record Dates

First Submitted

September 1, 2011

First Posted

September 20, 2011

Study Start

August 1, 2011

Primary Completion

January 1, 2015

Study Completion

February 1, 2015

Last Updated

February 6, 2015

Record last verified: 2015-02

Locations

CN(1)