An interventional study of calcium phosphate bone cement injection in Distal Radius Fracture, sponsored by Ewha Womans University. Completed at 1 site in South Korea. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2010-03-24.
Sponsored by Ewha Womans University · Not applicable, Interventional, and Treatment
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.
331 studies on the registry are indexed under Wrist Fractures; 71 are open to participants now.
This study's enrollment of 41 is below the median of 64 across 269 interventional studies indexed under Wrist Fractures.
Browse Wrist Fractures studies →Ewha Womans University is the lead sponsor of 41 studies on the registry; none are open to participants now.
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Exclusion Criteria:
one arm; volar locking plate alone the other arm; calcium phosphate bone cement as well as volar locking plate
Procedure: calcium phosphate bone cement injection
volar locking plate alone versus calcium phosphate bone cement as well as volar locking plate
Clinical outcomes
grip strength, wrist range of motion, subjective wrist pain, modified Mayo wrist score, and Disabilities of Arm, Shoulder and Hand score
Time frame: 12 months postoepratively
Radiographic outcomes
radial inclination and volar angulation and ulnar variance
Time frame: postoperatively 12 months
This study is completed, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.
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Ewha Womans University