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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

NCT01091415 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2010-03-24

No results posted yet for this study

Summary

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.

Conditions

  • Distal Radius Fracture

Interventions

PROCEDURE

calcium phosphate bone cement injection

volar locking plate alone versus calcium phosphate bone cement as well as volar locking plate

Sponsors & Collaborators

  • Ewha Womans University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01091415 on ClinicalTrials.gov