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CompletedNCT01437150Updated Feb 6, 2015

Treatment of Acetabular Posterior Wall Fracture With Anatomical Locking Plate

A Phase 4 interventional study of Anatomical locking plate and The Reconstructive Plate in Fracture of Acetabulum, sponsored by Peifu Tang. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-02-06.

Sponsored by Peifu Tang · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Fracture of Acetabulum

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Keywords

  • surgery
  • fixation
  • bone plate
03

In context

Fractures, Bone

2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.

This study's enrollment of 25 is below the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.

Browse Fractures, Bone studies →

Lead sponsor

Peifu Tang is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Simple posterior wall fracture

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

    Device: Anatomical locking plate · Procedure: The Reconstructive Plate

  • Experimental
    Complex posterior wall fracture

    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 plate · Procedure: The Reconstructive Plate

Interventions

  • DeviceAnatomical locking plate

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

    Also known as: WEIGAO ORTHOPAEDIC DEVICE CO.LTD., ZL200920105202.7

  • ProcedureThe Reconstructive Plate

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

    Also known as: The Reconstructive Plate System

06

What researchers measure

Primary outcomes

  1. Bone healing condition

    Bone healing condition was checked by radiological examination.

    Time frame: six months

Secondary outcomes

  1. Rates of revision surgery

    Time frame: one year

  2. Patient quality of life

    SF-36, ADL, FIM

    Time frame: one year

  3. Complications

    mortality, nonunion, implant breakage/failure, infection, DVT

    Time frame: one year

07

Study locations

1 site
  • Orthopedics department; The General Hospital of the People's Liberation Army
    Beijing, Beijing 100853, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01437150
Lead sponsor
Peifu Tang
Responsible party
Peifu Tang (Chief, Professor, Chinese PLA General Hospital) — Sponsor-investigator
First posted
Sep 20, 2011
Start date
Aug 2011
Primary completion
Jan 2015
Completion
Feb 2015
Last update
Feb 6, 2015

Study contacts

Tang Peifu, Dr.
study chair · Chinese PLA General Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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