Comparison the surgical outcome of Intertrochanteric fracture with gamma nail insertion through inferior _center and centre-centre blade entry point.
Design
The clinical trial includes two parallel study groups of 40 people with intertrochanteric fractures, who are randomly divided into intervention group 1 "applying inferior-center surgical technique" and intervention group 2 "applying center-center surgical technique".
Randomization was done by Random Number Generator software.
Samples are not blinded.
Settings and conduct
Patients under study who underwent gamma nail surgery were placed in one of the two lower methods. It will be placed in the back and center. Randomization in this research will be done with Random Number Generator software. After 6 months, the two groups will compare functional and radiological results.
Place and time: Taleghani hospital in 2020-2022.
Participants/Inclusion and exclusion criteria
The study selected 30 patients (Both genders with age > 50 year) with intertrochanteric fracture. Patients should be able to walk independently before the fracture to be chosen for study. To prevent the distortion of information, the fractures should not be pathological type and the patient didn’t have any previous fracture at the hip. All patients who don't follow these rules will exclude from the study.
Intervention groups
Applying the inferior-center surgical technique in the patients of intervention group 1 and applying the center-center surgical technique in the patients of the intervention group.
Main outcome variables
Functional and radiologic outcomes.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180404039188N4
Registration date:2022-12-29, 1401/10/08
Registration timing:retrospective
Last update:2022-12-29, 1401/10/08
Update count:0
Registration date
2022-12-29, 1401/10/08
Registrant information
Name
Reza Zandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2560
Email address
reza.zandi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2021-03-21, 1400/01/01
Actual recruitment start date
2020-03-20, 1399/01/01
Actual recruitment end date
2021-03-21, 1400/01/01
Trial completion date
2022-03-19, 1400/12/28
Scientific title
Comparison the surgical outcome of Intertrochanteric fracture with gamma nail insertion through inferior _center and centre-centre blade entry point.
Public title
Comparison of the Effectiveness of Acceptance and Commitment Therapy (ACT) with Cognitive-Behavioral Therapy (CBT)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 50 years, with Intertrochanteric fractures.
Exclusion criteria:
History of intertrochanteric fracture and surgery in the past.
Age
From 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization for 2 groups (1 Control, and 1 intervention groups), will done using software, 40 random numbers for each group. The surgeon can not play a role in predicting treatment of the disease, and choosing the type of treatment. Random sequence will generate by software. All admitted patients will be placed in one of the groups according to the pre-determined code.
Intervention group: Surgical technique of Intertrochanteric fracture with gamma nail insertion through inferior _center blade entry point.
Category
Treatment - Surgery
2
Description
Intervention group: Intervention group: Surgical technique of Intertrochanteric fracture with gamma nail insertion through center _center blade entry point.
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Reza Zandi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Erabi Ave, yemen Ave, chamran highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2303 1111
Fax
+98 21 2243 2570
Email
Reza.zandi@sbmu.ac.ir
Web page address
https://taleghani.sbmu.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Reza Zandi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Erabi street, Yamen Ave, chamran highway
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1111
Email
Reza.zandi@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Reza Zandi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Aarabi St.- Yaman St.-Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1111
Email
reza.zandi@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The data including age, gender, history of diseases (Coronary artery disease, diabetes and Hypertension) and other considered variable will be shared after deidentification.
When the data will become available and for how long
Data will be available after publication.
To whom data/document is available
People working in academic institutions
Under which criteria data/document could be used
Any type of analysis is prohibited unless the person in charge of the research is informed and would permit.
From where data/document is obtainable
Dr Reza Zandi Address: Aarabi St. - Yaman St. - Shahid Chamran Highway - Tehran Email: reza.zandi@sbmu.ac.ir
What processes are involved for a request to access data/document
Doing the letter writing accordance with the person in charge of the research