Treatment of Acetabular Posterior Wall Fracture With Anatomical Locking Plate

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Chinese PLA General Hospital
Sponsor:
Information provided by (Responsible Party):
Peifu Tang, Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT01437150
First received: September 1, 2011
Last updated: February 19, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Fracture of Acetabulum
Device: Anatomical locking plate
Procedure: The Reconstructive Plate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Treatment of Acetabular Posterior Wall Fracture With Anatomical Locking Plate

Resource links provided by NLM:


Further study details as provided by Chinese PLA General Hospital:

Primary Outcome Measures:
  • Bone healing condition [ Time Frame: six months ] [ Designated as safety issue: Yes ]
    Bone healing condition was checked by radiological examination.


Secondary Outcome Measures:
  • Rates of revision surgery [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • Patient quality of life [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    SF-36, ADL, FIM

  • Complications [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    mortality, nonunion, implant breakage/failure, infection, DVT


Estimated Enrollment: 36
Study Start Date: August 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
This is a new fixation treat for acetabular posterior wall fracture.
Other Names:
  • WEIGAO ORTHOPAEDIC DEVICE CO.LTD.
  • ZL200920105202.7
Procedure: The Reconstructive Plate
Reconstructive plate was used very common in treatment of acetabular fracture.
Other Name: The Reconstructive Plate System
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
This is a new fixation treat for acetabular posterior wall fracture.
Other Names:
  • WEIGAO ORTHOPAEDIC DEVICE CO.LTD.
  • ZL200920105202.7
Procedure: The Reconstructive Plate
Reconstructive plate was used very common in treatment of acetabular fracture.
Other Name: The Reconstructive Plate System

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01437150

Contacts
Contact: Tang Peifu, Dr. 86-10-99638101 pftang301@126.com
Contact: Shen Jing, Dr. 13718623511 orthjing@yahoo.com

Locations
China, Beijing
Orthopedics department; The General Hospital of the People's Liberation Army Recruiting
Beijing, Beijing, China, 100853
Contact: Tang Peifu, Dr.    86-10-99638101    pftang301@126.com   
Sub-Investigator: Shen Jing, Dr.         
Principal Investigator: Zhang Li Hai, Dr.         
Sponsors and Collaborators
Peifu Tang
Investigators
Study Chair: Tang Peifu, Dr. Chinese PLA General Hospital
  More Information

No publications provided

Responsible Party: Peifu Tang, Chief, Professor, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT01437150     History of Changes
Other Study ID Numbers: PLAGH OD 11
Study First Received: September 1, 2011
Last Updated: February 19, 2013
Health Authority: China: Ethics Committee

Keywords provided by Chinese PLA General Hospital:
surgery
fixation
bone plate

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on September 30, 2014