Treatment of Acetabular Posterior Wall Fracture With Anatomical Locking Plate

Fracture of Acetabulum Clinical Trial

Official title:

Treatment of Acetabular Posterior Wall Fracture With Anatomical Locking Plate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01437150
• Other study ID #: PLAGH OD 11
• Status: Completed
• Phase: Phase 4
• First received: September 1, 2011
• Last updated: February 4, 2015
• Start date: August 2011
• Est. completion date: February 2015

Study information

• Verified date: February 2015
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fracture of Acetabulum
• Fractures, Bone

Intervention

Device:
• Anatomical locking plate
This is a new fixation treat for acetabular posterior wall fracture.

Procedure:
• The Reconstructive Plate
Reconstructive plate was used very common in treatment of acetabular fracture.

Locations

Country	Name	City	State
China	Orthopedics department; The General Hospital of the People's Liberation Army	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peifu Tang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone healing condition	Bone healing condition was checked by radiological examination.	six months	Yes
Secondary	Rates of revision surgery		one year	Yes
Secondary	Patient quality of life	SF-36, ADL, FIM	one year	Yes
Secondary	Complications	mortality, nonunion, implant breakage/failure, infection, DVT	one year	Yes