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

This study has been completed.
Sponsor:
Information provided by:
Ewha Womans University
ClinicalTrials.gov Identifier:
NCT01091415
First received: March 19, 2010
Last updated: March 23, 2010
Last verified: December 2009
  Purpose

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.


Condition Intervention
Distal Radius Fracture
Procedure: calcium phosphate bone cement injection

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

Resource links provided by NLM:


Further study details as provided by Ewha Womans University:

Primary Outcome Measures:
  • Clinical outcomes [ Time Frame: 12 months postoepratively ] [ Designated as safety issue: No ]
    grip strength, wrist range of motion, subjective wrist pain, modified Mayo wrist score, and Disabilities of Arm, Shoulder and Hand score


Secondary Outcome Measures:
  • Radiographic outcomes [ Time Frame: postoperatively 12 months ] [ Designated as safety issue: No ]
    radial inclination and volar angulation and ulnar variance


Enrollment: 41
Study Start Date: March 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: calcium phosphate bone cement
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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01091415

Locations
Korea, Republic of
Ewha Womans University Hospital
Seoul, Korea, Republic of, 158-710
Sponsors and Collaborators
Ewha Womans University
  More Information

Publications:
Responsible Party: Jae Kwang Kim, Ewha Womans Mokdong Hospital
ClinicalTrials.gov Identifier: NCT01091415     History of Changes
Other Study ID Numbers: ECT
Study First Received: March 19, 2010
Last Updated: March 23, 2010
Health Authority: Republic of Korea: Food and Drug Administration

Additional relevant MeSH terms:
Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014