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
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.
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.
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 →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.
Exclusion Criteria:
Simple posterior wall fracture means the fracture was only occurred in the posterior wall of acetabular.
Device: Anatomical locking plate · Procedure: The Reconstructive Plate
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
This is a new fixation treat for acetabular posterior wall fracture.
Also known as: WEIGAO ORTHOPAEDIC DEVICE CO.LTD., ZL200920105202.7
Reconstructive plate was used very common in treatment of acetabular fracture.
Also known as: The Reconstructive Plate System
Bone healing condition
Bone healing condition was checked by radiological examination.
Time frame: six months
Rates of revision surgery
Time frame: one year
Patient quality of life
SF-36, ADL, FIM
Time frame: one year
Complications
mortality, nonunion, implant breakage/failure, infection, DVT
Time frame: one year
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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Peifu Tang