Comparing the treatment results of intramedullary suture anchor fixation method with tension band wiring method in patients with osteoporotic fractures of the olecranon
The aim of the present study is to compare the treatment outcomes of fixation of osteoporotic olecranon fractures provided by suture anchor fixation method and tension band wiring technique.
In this controlled multi-center clinical trial, 40 patients with osteoporotic olecranon fractures who refer to orthopedic clinics of Quaem, Imam Reza, and Shahid Kamyab hospitals will be enrolled in the study after giving consent. They will be randomly allocated into two groups of tension band wiring and intramedullary suture anchor fixation with 20 patients in each. All subjects will be followed-up for a minimum of 6 months and the treatment outcomes in terms of fracture union, range of motion of the elbow, complications, joint stability, and function will be compared between the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016022426734N1
Registration date:2017-07-05, 1396/04/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-07-05, 1396/04/14
Registrant information
Name
Ahmadreza Zarifian
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 915 359 7335
Email address
zarifianar891@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2021-03-20, 1399/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the treatment results of intramedullary suture anchor fixation method with tension band wiring method in patients with osteoporotic fractures of the olecranon
Public title
Comparison of two treatment methods for olecranon elbow fractures in patients with osteoporosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Olecranon fractures of Mayo type 1A & 2A including non-comminuted fractures of the olecranon without concomitant instability; Signs of Osteoporosis in pre-operative distal radial CT scan (218 HUD in women or 246 HUD in men); Patient consent for enrollment
Exclusion criteria: patient's unwillingness to continue the study; Patients with fractures other than Mayo type 1A & 2A
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization will be performed using closed envelops containing papers with odd or even numbers on them.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences, Medical School
Street address
Azadi Square, Mashhad University of Medical Sciences, Medical School
City
Mashhad
Postal code
Approval date
2017-04-15, 1396/01/26
Ethics committee reference number
IR.MUMS.fm.REC.1395.97
Health conditions studied
1
Description of health condition studied
Osteoporotic Olecranon Fractures
ICD-10 code
S52.0
ICD-10 code description
Fracture of upper end of ulna
2
Description of health condition studied
Osteoporotic Olecranon Fractures
ICD-10 code
M80
ICD-10 code description
Osteoporosis with pathological fracture
Primary outcomes
1
Description
fracture union
Timepoint
3, 6, 12, and 24 weeks after surgery
Method of measurement
elbow radiography
Secondary outcomes
1
Description
Need for re-operation
Timepoint
24 weeks after surgery
Method of measurement
Patient's profile
2
Description
Range of elbow motion
Timepoint
2nd and 6th week, then 3rd and 6th month and finally one year after surgery
Method of measurement
Orthopedic goniometer
3
Description
Elbow function
Timepoint
2nd and 6th week, then 3rd and 6th month and finally one year after surgery
Method of measurement
Mayo Elbow Performance Score
4
Description
Pain
Timepoint
2nd and 6th week, then 3rd and 6th month and finally one year after surgery
Method of measurement
VAS
Intervention groups
1
Description
Intervention group: Intramedullary suture anchor fixation of the fracture
Category
Treatment - Surgery
2
Description
Control group: Tension band wiring fixation of the fracture
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Quaem hospital
Full name of responsible person
Niloofar Alavi
Street address
Quaem Hospital, AhmadAbad Street, Mashhad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Saeed Eslami
Street address
Vice chancellor of Research, Ghorashi Building, Mashhad University of Medical Sciences, Daneshgah street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amir Reza Kachooei
Position
MD, Assistant Professor of Orthopedics
Other areas of specialty/work
Street address
Quaem Hospital, AhmadAbad Street, Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 3801 2638
Fax
+98 51 1841 7453
Email
kachoeear@mums.ac.ir
Web page address
http://kachooei.com/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amir Reza Kachooei
Position
MD, Assistant Professor of Orthopedics
Other areas of specialty/work
Street address
Quaem Hospital, AhmadAbad Street, Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 3801 2638
Fax
+98 51 3841 7453
Email
kachoeear@mums.ac.ir
Web page address
http://kachooei.com/
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ahmadreza Zarifian
Position
Medical Student
Other areas of specialty/work
Street address
Mashhad University of Medical Sciences, Azadi Square, Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 3801 2638
Fax
Email
zarifianar891@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)