Distal Radius Fracture Clinical Trial
Official title:
Comparison of Volar Locking Plate Fixation Alone and Volar Locking Plate Fixation Plus Calcium Phosphate Bone Cement Augmentation for Distal Radius Fractures Patients Aged More Than 65
The incidence of distal radius fracture (DRF) increases with age, and thus, because of
improving life expectancies, these fractures are set to become more common. Fractures of the
distal radial metaphysis are known to be strongly related to osteoporosis, and as a result,
the management of distal radius fractures in elderly patients is beset with difficulties.
Recently, more aggressive fracture fixation in the elderly has become a topic of interest,
in the hope of increasing the rate of recovery to preserve the ability to live
independently. Many elderly patients remain active well into their eighth and ninth decades,
for example, some pursue activities, such as, golf and tennis, on a daily basis. The
introduction of volar locking plating system has increased this interest. This system, which
uses a fixed angle principle, has been proposed to be effective at maintaining good anatomic
reduction, even in the elderly. However, there is a still concern about remaining
metaphyseal defect after reduction of the osteoporotic DRF.
Injectable calcium phosphate bone cement (CPC) has been used to augment the remaining
metaphyseal defect after fracture reduction including DRF, specially in osteoporotic old
patients. The purpose of this randomized, prospective study was to investigate that
additional CPC augmentation has any benefit over volar locking plate fixation in unstable
DRF patient who is older than 65. The null hypothesis is that there is no difference of
wrist functional outcomes, radiographic outcomes, and complications between treatment of
volar locking plate alone and calcium phosphate bone cement as well as volar locking plate
in unstable DRF patient who is older than 65.
n/a
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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