Back to resultsExtraarticular Distal Radius Fractures, X-fix or Volar Fixation
Primary Purpose
Dorsally Displaced Intraarticular Distal Radius Fractures, Age 50 - 74 for Females or 60-74 for Males, Low Energy Trauma
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
External fixation
Volar plate
Sponsored by
About this trial
This is an interventional treatment trial for Dorsally Displaced Intraarticular Distal Radius Fractures focused on measuring radius, fracture, wrist, external, fixation, volar, plate, DASH, PRWE
Eligibility Criteria
Inclusion Criteria:
- Female 50-74 years or male 60-74 years
- Dorsally displaced extraarticular distal radius fracture
- Dorsal angulation >20 degrees measured from the plane perpendicular to the radius axis
- Low energy trauma
- Injury <72 hours when diagnosed
- Patient independent of help for ADL
Exclusion Criteria:
- Earlier dysfunction in any wrist
- Other major injuries
- Rheumatoid arthritis or other systemic joint disease
- Dementia or severe psychiatric disease
- Severe medical condition making general anesthesia a considerable risk
Sites / Locations
- Stockholm South Hospital Department of Orthopeadic Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
External fixation
Volar plate
Arm Description
Operation with external fixation and optional addition of k-wire
Operation with Synthes volar two column plate (TCP)
Outcomes
Primary Outcome Measures
The primary outcome is measured by DASH (Disability of the Arm, Shoulder and Hand), which is a self administered questionnaire validated for disease and dysfunction of the upper limb.
Secondary Outcome Measures
A secondary outcome measure is the degree of malalignment on the x-ray of the injured wrist.
A secondary outcome measure for this study is the EQ5D, a validated quality-of-life instrument.
Full Information
NCT ID
NCT01034943
First Posted
December 16, 2009
Last Updated
March 12, 2014
Sponsor
Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT01034943
Brief Title
Extraarticular Distal Radius Fractures, X-fix or Volar Fixation
Official Title
Dorsally Displaced Extraarticular Distal Radius Fractures - Volar Plate or External Fixation. A Prospective Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Distal radius fractures are treated surgically if severely displaced. This study aims to investigate the outcome after surgery. The investigators will randomize patients to either external fixation with optional addition of k-wires or open reduction and fixation with a volar plate.
Detailed Description
This study has been merged with study NCT01035359 and a new ethical permission has been granted by the Swedish National Ethic board
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dorsally Displaced Intraarticular Distal Radius Fractures, Age 50 - 74 for Females or 60-74 for Males, Low Energy Trauma
Keywords
radius, fracture, wrist, external, fixation, volar, plate, DASH, PRWE
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
External fixation
Arm Type
Active Comparator
Arm Description
Operation with external fixation and optional addition of k-wire
Arm Title
Volar plate
Arm Type
Active Comparator
Arm Description
Operation with Synthes volar two column plate (TCP)
Intervention Type
Procedure
Intervention Name(s)
External fixation
Other Intervention Name(s)
External Fixation with Hoffman external fixator (Stryker)
Intervention Description
Operation with external fixation and optional addition of k-wire
Intervention Type
Procedure
Intervention Name(s)
Volar plate
Other Intervention Name(s)
Synthes volar two column plate (TCP)
Intervention Description
Operation with a Synthes volar two column plate (TCP)
Primary Outcome Measure Information:
Title
The primary outcome is measured by DASH (Disability of the Arm, Shoulder and Hand), which is a self administered questionnaire validated for disease and dysfunction of the upper limb.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
A secondary outcome measure is the degree of malalignment on the x-ray of the injured wrist.
Time Frame
12 months
Title
A secondary outcome measure for this study is the EQ5D, a validated quality-of-life instrument.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female 50-74 years or male 60-74 years
Dorsally displaced extraarticular distal radius fracture
Dorsal angulation >20 degrees measured from the plane perpendicular to the radius axis
Low energy trauma
Injury <72 hours when diagnosed
Patient independent of help for ADL
Exclusion Criteria:
Earlier dysfunction in any wrist
Other major injuries
Rheumatoid arthritis or other systemic joint disease
Dementia or severe psychiatric disease
Severe medical condition making general anesthesia a considerable risk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sari Ponzer, Professor
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stockholm South Hospital Department of Orthopeadic Surgery
City
Stockholm
ZIP/Postal Code
118 83
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Extraarticular Distal Radius Fractures, X-fix or Volar Fixation
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