Back to resultsUnstable Dorsally Displaced Fractures of the Distal Radius in the Elderly (VOCAL)
Primary Purpose
Fracture of the Distal Radius, Wrist Fracture
Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
open reduction and internal fixation with a volar plate
closed reduction and plaster treatment
Sponsored by
About this trial
This is an interventional treatment trial for Fracture of the Distal Radius focused on measuring elderly, wrist fracture, fracture of the distal radius, volar plate, plaster cast
Eligibility Criteria
Inclusion Criteria:
- Unilateral unstable dislocated dorsally angulated fracture of the distal radius (radial shortening ≥4 mm and/or dorsal angulation ≥20°).
Exclusion Criteria:
- Previous displaced fracture of the distal radius.
- Additional fractures of the upper extremities, an open fracture, terminal disease, patient not fit for surgery, unwilling or unable to co-operate with follow-up (advanced dementia (SPMSQ<5), psychiatric illness, alcohol abuse).
Sites / Locations
- Division of Orthopaedics Danderyd Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
ORIF
plaster treatment
Arm Description
Open reduction and internal fixation with a volar plate
Closed reduction and plaster treatment
Outcomes
Primary Outcome Measures
patient-perceived disability measured by the PRWE and DASH questionnaires
Secondary Outcome Measures
impairments (grip strength and range of motion compared with the uninjured wrist)
Full Information
NCT ID
NCT01268397
First Posted
December 29, 2010
Last Updated
February 6, 2019
Sponsor
Danderyd Hospital
Collaborators
Stockholm South General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01268397
Brief Title
Unstable Dorsally Displaced Fractures of the Distal Radius in the Elderly
Acronym
VOCAL
Official Title
Unstable Dorsally Displaced Fractures of the Distal Radius in the Elderly. A Randomized Comparison Between Operative Fixation and Plaster Cast Treatment.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 2009 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danderyd Hospital
Collaborators
Stockholm South General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to examine whether operation and fixation with a metal plate gives better result from the patient's perspective than plaster treatment in elderly patients with a displaced wrist fracture.
Detailed Description
We will perform a prospective randomized clinical trial comparing open reduction and internal fixation with a volar plate with closed reduction and plaster treatment in elderly patients with a displaced Colles' fracture in order to test the null hypothesis that the patient-perceived result is equal after conservative or operative treatment. Secondary outcomes are objective physical measurements.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture of the Distal Radius, Wrist Fracture
Keywords
elderly, wrist fracture, fracture of the distal radius, volar plate, plaster cast
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ORIF
Arm Type
Active Comparator
Arm Description
Open reduction and internal fixation with a volar plate
Arm Title
plaster treatment
Arm Type
Active Comparator
Arm Description
Closed reduction and plaster treatment
Intervention Type
Procedure
Intervention Name(s)
open reduction and internal fixation with a volar plate
Other Intervention Name(s)
plate: Königsee or Aculoc from Swemac, Sweden
Intervention Description
flexor carpi radialis approach, open reduction, fixed-angle volar plate, plaster cast 2 weeks at the surgeon's discretion
Intervention Type
Procedure
Intervention Name(s)
closed reduction and plaster treatment
Intervention Description
closed reduction, below elbow plaster cast, semicircular for 5 week
Primary Outcome Measure Information:
Title
patient-perceived disability measured by the PRWE and DASH questionnaires
Time Frame
one year after wrist fracture
Secondary Outcome Measure Information:
Title
impairments (grip strength and range of motion compared with the uninjured wrist)
Time Frame
one year after wrist fracture
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Unilateral unstable dislocated dorsally angulated fracture of the distal radius (radial shortening ≥4 mm and/or dorsal angulation ≥20°).
Exclusion Criteria:
Previous displaced fracture of the distal radius.
Additional fractures of the upper extremities, an open fracture, terminal disease, patient not fit for surgery, unwilling or unable to co-operate with follow-up (advanced dementia (SPMSQ<5), psychiatric illness, alcohol abuse).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Y Adolphson, MD, PhD
Organizational Affiliation
Karolinska Institute at Danderyd Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Division of Orthopaedics Danderyd Hospital
City
Stockholm
ZIP/Postal Code
S-18288
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35549696
Citation
Sudow H, Severin S, Wilcke M, Saving J, Skoldenberg O, Navarro CM. Non-operative treatment or volar locking plate fixation for dorsally displaced distal radius fractures in patients over 70 years - a three year follow-up of a randomized controlled trial. BMC Musculoskelet Disord. 2022 May 12;23(1):447. doi: 10.1186/s12891-022-05394-7.
Results Reference
derived
Learn more about this trial
Unstable Dorsally Displaced Fractures of the Distal Radius in the Elderly
We'll reach out to this number within 24 hrs