Volar Locking Plate Versus External Fixator/Cast Fixation for the Treatment of Distal Radius Fractures
Primary Purpose
Distal Radius Fractures
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
volar locking plating
external immobilisation
Sponsored by
About this trial
This is an interventional treatment trial for Distal Radius Fractures
Eligibility Criteria
Inclusion Criteria:
- distal radius fracture
- age > 18
Exclusion Criteria:
- intellectual or mental impairment
- < 18 years of age
Sites / Locations
- Mackay Base Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
volar locking plating of distal radius fractures
Outcomes
Primary Outcome Measures
20% difference in DASH scores
Secondary Outcome Measures
return to work
Full Information
NCT ID
NCT00809861
First Posted
December 16, 2008
Last Updated
May 28, 2014
Sponsor
Mackay Base Hospital
Collaborators
James Cook University, Queensland, Australia
1. Study Identification
Unique Protocol Identification Number
NCT00809861
Brief Title
Volar Locking Plate Versus External Fixator/Cast Fixation for the Treatment of Distal Radius Fractures
Official Title
Volar Locking Plate Versus External Fixator/Cast Fixation for the Treatment of Distal Radius Fractures. A Randomised Controlled Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mackay Base Hospital
Collaborators
James Cook University, Queensland, Australia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Aim: Osteosynthesis with locking plate/screws has become increasingly popular in recent years. It is the only treatment option which allows immediate postoperative immobilization. However, compared to conservative treatment or treatment with external fixators, locking plates are very expensive and the operation can be very challenging, even for experienced surgeons. The long-term results of all treatment modalities are equal, which has been shown in numerous studies. However, there are no evidence based studies published yet which look at short-term outcomes. The investigators do feel but do not know that patients who do not need postoperative immobilization return to work significantly earlier or are independent faster than patients whose wrists are immobilized for up to 6 weeks. If that is the case, then the higher costs and risks of the operation are justified, if not, then we have to re-evaluate our indications for using locking distal radius plates distal radius Methods: Group 1: Treatment of distal radius fractures with either volar or dorsal locking plates. No fixation postoperatively, immediate ROM (range of motion) exercises and usage of the wrist in activities of daily life (ADL) allowed.
Radiological and clinical controls 2 weeks, 6 weeks and 12 weeks postoperatively. Endpoints are time to return to work / return to independency (in older people), ROM; Grip strength (with Jamar Dynamometer).
Outcome scores are DASH (Disability of Arm, Shoulder and Hand Score)and PRWE (Patient related wrist evaluation).
Group 2 Treatment of distal radius fractures with either an external fixator +/- K-wires or with K-wires and forearm cast or by cast alone. Main issue is that the wrist is immobilized for a period of 6 weeks. Radiological and clinical controls 2 weeks, 6 weeks and 12 weeks postoperatively. Endpoints are time to return to work / return to independency (in older people), ROM; Grip strength (with Jamar Dynamometer). Outcome scores are DASH and PRWE. Both plating and external fixation / cast fixation are standard and accepted treatment modalities for distal radius fractures. A power analysis indicated that a total sample size of 52 patients randomized equally (1:1) to each treatment arm without any blocking or stratification would provide 80 % statistical power (alpha = .05, beta = .20) to detect a 20% difference in mean DASH and PRWE scores.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
volar locking plating of distal radius fractures
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
volar locking plating
Intervention Description
open reduction and internal fixation
Intervention Type
Procedure
Intervention Name(s)
external immobilisation
Intervention Description
closed reduction and external fixation
Primary Outcome Measure Information:
Title
20% difference in DASH scores
Time Frame
twelve weeks
Secondary Outcome Measure Information:
Title
return to work
Time Frame
twelve weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
distal radius fracture
age > 18
Exclusion Criteria:
intellectual or mental impairment
< 18 years of age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herwig Drobetz, MD
Organizational Affiliation
Mackay Base Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mackay Base Hospital
City
Mackay
State/Province
Queensland
ZIP/Postal Code
4740
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Volar Locking Plate Versus External Fixator/Cast Fixation for the Treatment of Distal Radius Fractures
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