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
Primary Purpose
Distal Radius Fracture
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
calcium phosphate bone cement injection
Sponsored by
About this trial
This is an interventional treatment trial for Distal Radius Fracture
Eligibility 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.
Sites / Locations
- Ewha Womans University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
calcium phosphate bone cement
Arm Description
one arm; volar locking plate alone the other arm; calcium phosphate bone cement as well as volar locking plate
Outcomes
Primary Outcome Measures
Clinical outcomes
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
radial inclination and volar angulation and ulnar variance
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01091415
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ewha Womans University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
calcium phosphate bone cement
Arm Type
Experimental
Arm Description
one arm; volar locking plate alone the other arm; calcium phosphate bone cement as well as volar locking plate
Intervention Type
Procedure
Intervention Name(s)
calcium phosphate bone cement injection
Intervention Description
volar locking plate alone versus calcium phosphate bone cement as well as volar locking plate
Primary Outcome Measure Information:
Title
Clinical outcomes
Description
grip strength, wrist range of motion, subjective wrist pain, modified Mayo wrist score, and Disabilities of Arm, Shoulder and Hand score
Time Frame
12 months postoepratively
Secondary Outcome Measure Information:
Title
Radiographic outcomes
Description
radial inclination and volar angulation and ulnar variance
Time Frame
postoperatively 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Ewha Womans University Hospital
City
Seoul
ZIP/Postal Code
158-710
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
14751111
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. doi: 10.1016/j.jhsa.2003.09.015.
Results Reference
background
PubMed Identifier
11937863
Citation
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.
Results Reference
background
PubMed Identifier
15614440
Citation
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.
Results Reference
background
Learn more about this trial
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
We'll reach out to this number within 24 hrs