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Treatment of Acetabular Posterior Wall Fracture With Anatomical Locking Plate

Primary Purpose

Fracture of Acetabulum

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Anatomical locking plate
The Reconstructive Plate
Sponsored by
Peifu Tang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fracture of Acetabulum focused on measuring surgery, fixation, bone plate

Eligibility Criteria

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

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Simple posterior wall fracture

Complex posterior wall fracture

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Bone healing condition
Bone healing condition was checked by radiological examination.

Secondary Outcome Measures

Rates of revision surgery
Patient quality of life
SF-36, ADL, FIM
Complications
mortality, nonunion, implant breakage/failure, infection, DVT

Full Information

First Posted
September 1, 2011
Last Updated
February 4, 2015
Sponsor
Peifu Tang
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1. Study Identification

Unique Protocol Identification Number
NCT01437150
Brief Title
Treatment of Acetabular Posterior Wall Fracture With Anatomical Locking Plate
Official Title
Treatment of Acetabular Posterior Wall Fracture With Anatomical Locking Plate
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Peifu Tang

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Acetabular fractures were very common in high-energy injury, because of the anatomic of acetabular was in deep location and the complex form cause the diagnosis and treatment was difficult. For most of displaced acetabular fractures, the preferred treatment is open reduction and internal fixation. The purpose of surgery is to restore acetabular integrity and stability, allow early exercise, decrease complication. Acetabular posterior wall fractures were the most common, the current clinical application fixation of acetabular fractures were common plate and reconstruction steel plate. But when the acetabular posterior wall was fracture, some patients were not satisfied after surgery. The reason is mainly because the reconstruction plate need remoulding in surgery, and it not only led to the extension of operation time, but also cause poor attach. Otherwise, the reconstruction plate need location the angle of screw in surgery. If the operator lack of experience will make into the harm surrounding vessels and nerves. Some research has achieved the improvement from the anatomy of acetabular fractures in the locking plate. But there is not any plate match with the anatomy of the acetabular posterior wall. This anatomical bone plate was designed base on before plate and had patent protection which is used in clinical trial. It was a new type of internal fixation of acetabular posterior wall fracture, this plate improve the shortcomings of existing technology, provides a pre-formed anatomical fixation plate , the direction of the locking screw holes. This design provide a better attach of acetabular posterior wall, more safe use the screw, making more stable and reliable fixation. This fixation plate was not only suitable for an experienced doctor, but also suitable for a less experienced doctors in theory. They can quickly and accurately fixed in its correct position, thus this fixation plate have advantages of improve surgical success rates, shorter hospital stay, reduce disease painful and it can used in all adult patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture of Acetabulum
Keywords
surgery, fixation, bone plate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Simple posterior wall fracture
Arm Type
Experimental
Arm Description
Simple posterior wall fracture means the fracture was only occurred in the posterior wall of acetabular.
Arm Title
Complex posterior wall fracture
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Anatomical locking plate
Other Intervention Name(s)
WEIGAO ORTHOPAEDIC DEVICE CO.LTD., ZL200920105202.7
Intervention Description
This is a new fixation treat for acetabular posterior wall fracture.
Intervention Type
Procedure
Intervention Name(s)
The Reconstructive Plate
Other Intervention Name(s)
The Reconstructive Plate System
Intervention Description
Reconstructive plate was used very common in treatment of acetabular fracture.
Primary Outcome Measure Information:
Title
Bone healing condition
Description
Bone healing condition was checked by radiological examination.
Time Frame
six months
Secondary Outcome Measure Information:
Title
Rates of revision surgery
Time Frame
one year
Title
Patient quality of life
Description
SF-36, ADL, FIM
Time Frame
one year
Title
Complications
Description
mortality, nonunion, implant breakage/failure, infection, DVT
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tang Peifu, Dr.
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Orthopedics department; The General Hospital of the People's Liberation Army
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China

12. IPD Sharing Statement

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Treatment of Acetabular Posterior Wall Fracture With Anatomical Locking Plate

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