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

Not Applicable

Completed

• Conditions: Distal Radius Fracture
• Interventions: Procedure: calcium phosphate bone cement injection

• Registration Number: NCT01091415
• Lead Sponsor: Ewha Womans University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Status Verified: 2009-12
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Study First Submitted: 2010-03-19
• Study First Submitted QC: 2010-03-23
• Last Update Submitted: 2010-03-23
• Study First Posted: 2010-03-24
• Last Update Posted: 2010-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• All patients older than 65 years old with an acute DRF were considered for inclusion for this study. Inclusion criterion of this study was an unacceptable closed reduction after one attempt of closed reduction. The criteria of unacceptable closed reduction included dorsal angulation of > 100, volar angulation of > 200, an articular gap or step off of >2 mm, radial inclination of <100, or radial shortening of > 5mm.

Exclusion Criteria

• A preexisting severe illness
• An ipsilateral upper extremity injury
• A previous wrist injury
• Surgical delay of more than 2 weeks
• A concomitant ulnar neck fracture.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
calcium phosphate bone cement	calcium phosphate bone cement injection	one arm; volar locking plate alone the other arm; calcium phosphate bone cement as well as volar locking plate

Primary Outcome Measures

Name	Time	Method
Clinical outcomes	12 months postoepratively	grip strength, wrist range of motion, subjective wrist pain, modified Mayo wrist score, and Disabilities of Arm, Shoulder and Hand score

Secondary Outcome Measures

Name	Time	Method
Radiographic outcomes	postoperatively 12 months	radial inclination and volar angulation and ulnar variance

Trial Locations

Locations (1)

Ewha Womans University Hospital; 🇰🇷 Seoul, Korea, Republic of