Treatment of Acetabular Posterior Wall Fracture With Anatomical Locking Plate

NCT ID: NCT01437150

Last Updated: 2015-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2015-02-28

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.

Conditions

Fracture of Acetabulum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Simple posterior wall fracture

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

Group Type: EXPERIMENTAL

Anatomical locking plate

Intervention Type: DEVICE

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

The Reconstructive Plate

Intervention Type: PROCEDURE

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

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.

Group Type: EXPERIMENTAL

Anatomical locking plate

Intervention Type: DEVICE

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

The Reconstructive Plate

Intervention Type: PROCEDURE

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

Interventions

Anatomical locking plate

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

Intervention Type: DEVICE

The Reconstructive Plate

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

Intervention Type: PROCEDURE

Other Intervention Names

WEIGAO ORTHOPAEDIC DEVICE CO.LTD.; ZL200920105202.7; The Reconstructive Plate System

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peifu Tang

OTHER

Sponsor Role: lead

Responsible Party

Peifu Tang

Chief, Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Tang Peifu, Dr.

Role: STUDY_CHAIR

Chinese PLA General Hospital

Locations

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

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

PLAGH OD 11

Identifier Type: -

Identifier Source: org_study_id