Unstable Distal Radius Fractures With Dorsal Dislocation in Patients Aged 18-64 Years. Volar Locking Plate (VLP) vs Closed Reduction and Percutaenous Pinning (CRPP).
Primary Purpose
Distal Radius Fractures, Wrist Fracture, Colles' Fracture
Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Open reduction and volar locking plate and closed reduction and K-wires.
Sponsored by
About this trial
This is an interventional treatment trial for Distal Radius Fractures
Eligibility Criteria
Inclusion Criteria:
- distal radius fractures of AO- A2, A3 and C1 which should be operated on in accordance with Norwegian guidelines
- >18 years and <65 years
- address in Oslo municipality
Exclusion Criteria:
- multitrauma
- previous fracture same wrist
- multiple injuries on the same side
- not competent to consent
- dementia / nursing home patient
- substance abuse
- foreign / tourists
- median nerve compression requiring emergency surgery
- pathological fracture
- open fracture
- congenital malformations that make it difficult to interpret data
- patient does not want surgical treatment
- not operable due to comorbidity (ASA 4, some ASA 3 after assessment by anesthesiologist)
- more than 10 days after injury
Sites / Locations
- SkadelegevaktenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
VLP
CRPP
Arm Description
Open reduction and volar locking plate
Closed reduction and percutaenous K-wires/pins
Outcomes
Primary Outcome Measures
Patient-Related Wrist and Hand Evaluation (PRWHE) score
PROM of 15 questions, score ranging from 0 (best) to 100 (worst)
Secondary Outcome Measures
Quick Dash score
PROM of 11 questions, score ranging from 0 (best) to 100 (worst)
X-ray wrist posterior-anterior and lateral view
Volar tilt (degrees), radial inclination (degrees), ulnar variance (mm), stepp-off (mm)
Range of motion
Flexion, extension, supination and pronation measured in degrees from neutral position, pulpa palm distance in cm
Grip strength
Grip strength with a hand dynamometer
Full Information
NCT ID
NCT04716309
First Posted
January 14, 2021
Last Updated
April 26, 2022
Sponsor
Oslo University Hospital
Collaborators
Sophies Minde
1. Study Identification
Unique Protocol Identification Number
NCT04716309
Brief Title
Unstable Distal Radius Fractures With Dorsal Dislocation in Patients Aged 18-64 Years. Volar Locking Plate (VLP) vs Closed Reduction and Percutaenous Pinning (CRPP).
Official Title
Unstable Distal Radius Fractures AO-type A2, A3 and C1 With Dorsal Dislocation in Patients Aged 18-64 Years. Open Reduction and Volar Locking Plate Versus Closed Reduction and Percutaenous Pinning. A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 16, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Sophies Minde
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
120 patients age 18-64 years with dorsally displaced distal radius fractures AO-type A2, A3 and C1 are recruited from Oslo Casualty Medical Centre (Oslo Skadelegevakt). Patients are randomized to surgery with closed reduction and pins (CRPP) or open reduction and volar locking plate (VLP). The hypotheses is that CRPP will give equal function and satisfaction to VLP. Patients are followed by current practice of follow-ups until 5 weeks postoperatively, and in addition due to the study with functional tests after 2, 3, 6 and 12 months. These follow-ups will be performed by hand therapist. Scores are also recorded from Patient-Reported Wrist and Hand Evaluation (PRWHE), Quick-Dash (Q-d) and EuroQol Questionnaire (EQ-5D) questionnaires. The main efficacy measure in the study is PRWHE scores after 12 months. There will be X-ray initially, postoperatively and after 12 months. Sub-objectives in the study are analyses of cost-effectiveness (measured by EQ 5D, personnel use, use of additional healthcare service and absence from work), and differences in complications between the two methods.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fractures, Wrist Fracture, Colles' Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
VLP
Arm Type
Active Comparator
Arm Description
Open reduction and volar locking plate
Arm Title
CRPP
Arm Type
Active Comparator
Arm Description
Closed reduction and percutaenous K-wires/pins
Intervention Type
Procedure
Intervention Name(s)
Open reduction and volar locking plate and closed reduction and K-wires.
Intervention Description
DVR Anatomic Plate, K-wires
Primary Outcome Measure Information:
Title
Patient-Related Wrist and Hand Evaluation (PRWHE) score
Description
PROM of 15 questions, score ranging from 0 (best) to 100 (worst)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Quick Dash score
Description
PROM of 11 questions, score ranging from 0 (best) to 100 (worst)
Time Frame
1 year
Title
X-ray wrist posterior-anterior and lateral view
Description
Volar tilt (degrees), radial inclination (degrees), ulnar variance (mm), stepp-off (mm)
Time Frame
1 year
Title
Range of motion
Description
Flexion, extension, supination and pronation measured in degrees from neutral position, pulpa palm distance in cm
Time Frame
1 year
Title
Grip strength
Description
Grip strength with a hand dynamometer
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
distal radius fractures of AO- A2, A3 and C1 which should be operated on in accordance with Norwegian guidelines
>18 years and <65 years
address in Oslo municipality
Exclusion Criteria:
multitrauma
previous fracture same wrist
multiple injuries on the same side
not competent to consent
dementia / nursing home patient
substance abuse
foreign / tourists
median nerve compression requiring emergency surgery
pathological fracture
open fracture
congenital malformations that make it difficult to interpret data
patient does not want surgical treatment
not operable due to comorbidity (ASA 4, some ASA 3 after assessment by anesthesiologist)
more than 10 days after injury
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Børge Olsen, MD
Phone
+4799263657
Email
borge.ols1@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
John Williksen, MD
Phone
+4792285918
Email
uxwilj@ous_hf.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Williksen, MD
Organizational Affiliation
Oslo University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Skadelegevakten
City
Oslo
ZIP/Postal Code
0182
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Borge Olsen, MD
Phone
+4799263657
Email
boerol@ous-hf.no
First Name & Middle Initial & Last Name & Degree
John Williksen, MD
Phone
+4792285918
Email
uxwilj@ous-hf.no
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Unstable Distal Radius Fractures With Dorsal Dislocation in Patients Aged 18-64 Years. Volar Locking Plate (VLP) vs Closed Reduction and Percutaenous Pinning (CRPP).
We'll reach out to this number within 24 hrs