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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01091415
• Other study ID #: ECT
• Status: Completed
• Phase: N/A
• First received: March 19, 2010
• Last updated: March 23, 2010
• Start date: March 2007
• Est. completion date: December 2009

Study information

• Verified date: December 2009
• Source: Ewha Womans University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Republic of Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Radius Fractures

Intervention

Procedure:
• calcium phosphate bone cement injection
volar locking plate alone versus calcium phosphate bone cement as well as volar locking plate

Locations

Country	Name	City	State
Korea, Republic of	Ewha Womans University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Ewha Womans University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

Larsson S, Bauer TW. Use of injectable calcium phosphate cement for fracture fixation: a review. Clin Orthop Relat Res. 2002 Feb;(395):23-32. Review. — View Citation

Orbay JL, Fernandez DL. Volar fixed-angle plate fixation for unstable distal radius fractures in the elderly patient. J Hand Surg Am. 2004 Jan;29(1):96-102. — View Citation

Ring D, Jupiter JB. Treatment of osteoporotic distal radius fractures. Osteoporos Int. 2005 Mar;16 Suppl 2:S80-4. Epub 2004 Dec 22. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical outcomes	grip strength, wrist range of motion, subjective wrist pain, modified Mayo wrist score, and Disabilities of Arm, Shoulder and Hand score	12 months postoepratively	No
Secondary	Radiographic outcomes	radial inclination and volar angulation and ulnar variance	postoperatively 12 months	No