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Comparing assessment of dynamic hip screw and cannulated screws fixation for femoral neck fracture

Protocol summary

Summary
The aim of this study is comparing of two prosthesis include short-stem and long stem. 70 cases of that refer to Sina hospital, Tehran, Iran due to femoral neck fracture will participate in each groups. The first we perform preparation before operation, for example, lab test, blood group, blood reserve, cardiology and analgesic consultation. After obtaining written informed consent for the surgery, patients will be randomly assigned in study groups. The Patients will be visited at the weeks 2 and 6 and months 3, 6 and 12 after surgery. Early complications include wound infection, early failure and late complications include avascular necrosis, loss of fixation, bread Union will be assessed. The frequency of treatment to track effects of setup time, setup quality time union attain acceptable levels of pain relief, patient satisfaction with the surgery will be measured. Clinical outcome and patients satisfaction will be evaluated with Harris Hip Score and SF-12, respectively.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013030911560N5
Registration date: 2013-09-10, 1392/06/19
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-09-10, 1392/06/19
Registrant information
Name
Tayeb Ramim
Name of organization / entity
Sina Trauma and Surgery Research Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6312 0000
Email address
tayebramim@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research in Tehran University of Medical Sciences
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2015-03-21, 1394/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing assessment of dynamic hip screw and cannulated screws fixation for femoral neck fracture
Public title
Surgery treatment in hip fracture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: femoral neck fracture (with digital radiography); age < 60 years old; acute traumatic fracture (< 72 hour after trauma); independence motion; no history of mental disorders; full consciousness; no concordance fracture that influence fixation of fracture. Exclusion criterion: patients without cooperation and no follow up
Age
To 60 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 140
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Hemat gateway, Central devision of Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2013-02-19, 1391/12/01
Ethics committee reference number
1391/05/14211

Health conditions studied

1

Description of health condition studied
Femoral neck fracture
ICD-10 code
S72.0
ICD-10 code description
Fracture of neck of femur

Primary outcomes

1

Description
Union time
Timepoint
At the weeks 2 and 6 and months 3, 6 and 12 after surgery
Method of measurement
Radilogical study

Secondary outcomes

1

Description
Function
Timepoint
At the weeks 2 and 6 and months 3, 6 and 12 after surgery
Method of measurement
Harris Hip Score

Intervention groups

1

Description
The use of dynamic hip screw for repairing of femoral neck fracture.
Category
Treatment - Surgery

2

Description
The use of cannulated screw for repairing of femoral neck fracture.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Arash Ali Rezaii
Street address
Sina Hospital, Imam Khomeini St, Hasan Abad Sq
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of Research,Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Central building of Tehran University of Medical sciences, Ghods st., Keshavarz blv.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research,Tehran 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
Sina Hospital, Tehran University of Medical Sciences
Full name of responsible person
Arash Ali Rezaii
Position
Clinical Assistant
Other areas of specialty/work
Street address
Imam khomeni St, Hasan Abad Sq, Sina hospital
City
Tehran
Postal code
Phone
+98 21 6312 0000
Fax
Email
arash_ar80@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sina Hospital, Tehran University of Medical Sciences
Full name of responsible person
Arash Ali Rezaii
Position
Clinical Assistant
Other areas of specialty/work
Street address
Imam khomeni St, Hasan Abad Sq, Sina hospital
City
Tehran
Postal code
Phone
+98 21 6312 0000
Fax
Email
arash_ar80@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Sina Trauma and Surgery Research Center
Full name of responsible person
Tayeb Ramim
Position
Researcher
Other areas of specialty/work
Street address
Imam khomeni St, Hasan Abad Sq, Sina hospital
City
Tehran
Postal code
Phone
+98 21 6312 4524
Fax
Email
dr.tayebramim@gamil.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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