The aim of this multi-center study is to compare some outcomes including pain, range of motion and grip strength of both fixation and non-fixation treatments of ulnar styloid in distal radius fractures. All adults with distal radius fractures and ulnar styloid fractures would met the inclusion criteria. Sealed pockets will be used for randomization. Sample size has been estimated at least 78 cases. In intervention group, open pinning and long arm casting and in the control group long arm casting in supination position will be performed for six weeks. Physical therapy will be performed for 6 weeks after surgery. Patients will be followed up at 2, 4, 6, 8 weeks and 3, 6, 12 months after surgery. Ultimately pain, wrist's range of motion, ulnar styloid tenderness, Mayo score and Dash score will be assessed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016061828510N1
Registration date:2016-07-13, 1395/04/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-07-13, 1395/04/23
Registrant information
Name
Ali Moradi
Name of organization / entity
Orthopedic Research Center of Ghaem Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3801 2638
Email address
moradial@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Mashhad University of Medical Sciences
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of ulnar styloid fracture fixation in outcome of distal radius fractures
Public title
The effect of ulnar styloid fracture fixation in treatment of radius fracture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Adults with ulnar styloid combined with distal radius fracture.
Exclusion criteria: Age less than 18 years old; history of previous fracture or deformity; time between injury and admission more than two weeks; open fracture; fracture with nerve injury; patients with systemic disorders such as rheumatoid arthritis.
Age
From 18 years old to 100 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization will be done using sealed envelopes.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Ethics committee of Mashhad University of Medical Sciences, Daneshgah street, Mashhad, Iran
City
Mashhad
Postal code
Approval date
2016-06-22, 1395/04/02
Ethics committee reference number
IR.MUMS.SM.REC.1394.468
Health conditions studied
1
Description of health condition studied
distal radius fractures
ICD-10 code
S52.5, S52
ICD-10 code description
Fracture of lower end of radius,Fracture of lower end of both ulna and radius
Primary outcomes
1
Description
Grip strength
Timepoint
Physical examination before surgery
Method of measurement
Dynomometer
2
Description
Pain
Timepoint
Physical examination before surgery
Method of measurement
Vas score with questionnaire
Secondary outcomes
1
Description
Range of motion
Timepoint
2 weeks, 4 weeks, 6 weeks, 8 weeks , 3 months, 6 months and 12 months after surgery
Method of measurement
Physical examination
2
Description
DASH score
Timepoint
2 weeks, 4 weeks, 6 weeks, 8 weeks , 3 months, 6 months and 12 months after surgery
Method of measurement
questionnaire
3
Description
MAYO score
Timepoint
2 weeks, 4 weeks, 6 weeks, 8 weeks , 3 months, 6 months and 12 months after surgery
Method of measurement
Check list
4
Description
Pain
Timepoint
2 weeks, 4 weeks, 6 weeks, 8 weeks , 3 months, 6 months and 12 months after surgery
Method of measurement
Vas score with questionnaire
Intervention groups
1
Description
Fixation of ulnar styloid in distal radius fracture will use in intervention group
Category
Treatment - Surgery
2
Description
for control group we will not fix ulnar styloid in distal radius fracture