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 | Completed DMC

• 1 other identifier: ECT
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Distal Radius Fracture

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Radiographic outcomes

  postoperatively 12 months

Study Arms (1)

calcium phosphate bone cement

EXPERIMENTAL

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

Interventions

calcium phosphate bone cement injection PROCEDURE

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

calcium phosphate bone cement

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ewha Womans University: lead

Study Sites (1)

Ewha Womans University Hospital

Seoul, 158-710, South Korea

Location

Related Publications (3)

• 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. doi: 10.1016/j.jhsa.2003.09.015.

  PMID: 14751111 BACKGROUND

• Larsson S, Bauer TW. Use of injectable calcium phosphate cement for fracture fixation: a review. Clin Orthop Relat Res. 2002 Feb;(395):23-32. doi: 10.1097/00003086-200202000-00004.

  PMID: 11937863 BACKGROUND

• Ring D, Jupiter JB. Treatment of osteoporotic distal radius fractures. Osteoporos Int. 2005 Mar;16 Suppl 2:S80-4. doi: 10.1007/s00198-004-1808-x. Epub 2004 Dec 22.

  PMID: 15614440 BACKGROUND

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 19, 2010
• First Posted: March 24, 2010
• Study Start: March 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: March 24, 2010

Record last verified: 2009-12

Locations

KR (1)