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The effect of lesser trochanter fixation on hip flexion strength in patients with intertrochantric fx of femur in Karaj Madani hospital

Protocol summary

Study aim
Investigating the effect of lesser trochanter fixation on hip joint flexion strength in patients with femoral intertrochanteric fracture.
Design
Clinical trial with control group, double blind, randomized, phase 2 on 52 patients. Excel software was used for randomization.
Settings and conduct
Patients referred to Shahid Madani Medical Education Center during 1401 were randomly divided into two groups, in the intervention group,after the main surgery, the lesser trochanter was also fixed with a wire, and in the control group, was not fixed. Next, at 6-week, 3-month, and 6-month intervals, hip flexion strength will be compared with the opposite limb. The strength of hip joint flexion is measured manually and varies from zero-fifth to five-fifth.The examination of muscle strength is done by(Dr. Mohammad Sajjad Mir Hosseini), who is the project guide, and doesn't know which group the examinee belongs to.
Participants/Inclusion and exclusion criteria
Inc criteria: 1) Patients with intertrochanteric fracture of the femur with separation of the lesser trochanter referred to Shahid Madani Medical Training Center during 1401 2) Mastery of speech and understanding of Persian language 3) Consent to participate in the study 4) Age> 18 yrs Exc criteria: 1) Lack of consent to participate in the study 2) Contraindications for surgery 3) Concomitant diseases that affect the power of limb flexion.
Intervention groups
Patients referred to Shahid Madani Medical Education Center during 1401 were randomly divided into two groups, in the intervention group,after the main surgery, the lesser trochanter was fixed with a wire, and in the control group was not fixed
Main outcome variables
flexion strength of the hip joint

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230117057145N1
Registration date: 2023-02-26, 1401/12/07
Registration timing: registered_while_recruiting

Last update: 2023-02-26, 1401/12/07
Update count: 0
Registration date
2023-02-26, 1401/12/07
Registrant information
Name
Hamid Sohrabian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3444 3284
Email address
hamiso1988@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-07-23, 1402/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of lesser trochanter fixation on hip flexion strength in patients with intertrochantric fx of femur in Karaj Madani hospital
Public title
The effect of lesser trochanter fixation on hip flexion strength
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with intertrochantric fx of femur and lesser trochantric fx age over 18 years
Exclusion criteria:
Contraindications for surgery The presence of previous diseases that affect the flexion power of the limb and interfere with the examination process (such as neuromuscular diseases, stroke, limb paralysis, etc.) The patient's lack of consent to participate in the trial
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 52
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization among patients with simultaneous intertrochanteric fracture of the femur bone and separation of the lesser trochanter is a simple randomization method, the randomization unit is individual and using a table of random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Examination of muscle strength by only one orthopedic surgeon (Dr. Mohammad Sajjad Mir Hosseini) who is the master of the project It is carried out and the examiner is not aware of which group the examinee belongs to. Also the patients themselves are not aware of which group they are in (double blind).
Placebo
Not used
Assignment
Parallel
Other design features
Patients with the same type of fracture are divided into two groups. In the first or control group, routine and gold standard treatment of intertrochanteric fracture is performed. In the intervention group, in addition to routine and gold standard fracture treatment, fixation of the lesser trochanter of the femur is also done with the help of wire. is done and the purpose of the study is to investigate the effect of fixation on hip flexion strength

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Alborz University of Medical Sciences
Street address
Taleghani Square, North Taleghani Blvd, Alborz University of Medical Sciences
City
karaj
Province
Alborz
Postal code
3149779453
Approval date
2022-12-03, 1401/09/12
Ethics committee reference number
IR.ABZUMS.REC.1401.251

Health conditions studied

1

Description of health condition studied
intertrochanteric fx of femur
ICD-10 code
S72.1
ICD-10 code description
Pertrochanteric fracture

Primary outcomes

1

Description
Flexion strength in patients with femoral intertrochanteric fracture
Timepoint
Measuring hip flexion strength at intervals of 6 weeks, 12 weeks, 24 weeks (6 months)
Method of measurement
manual muscle testing (from zero fifth to five fifth)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: patients with intertrochanteric fracture of the femur who simultaneously have separation of the lesser trochanter. In these patients, in addition to the surgical treatment of intertrochanteric fracture (using common methods such as using DHS plate or cephalomedullary nail, etc.), their femoral lesser trochanter is also fixed with the help of wire. To perform the intervention (fixation of the lesser trochanter), no other tool is needed except for the wire and its guide (wire passer).
Category
Treatment - Surgery

2

Description
Control group: patients with simultaneous intertrochanteric fracture and separation of the lesser trochanter of the femur, who are treated commonly and routinely, but fixation of the lesser trochanter is not done in them.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
shahid Madani hospital
Full name of responsible person
Hamid sohrabian
Street address
Mahan Boulevard, Madani Square, Shahid Madani Hospital
City
Karaj
Province
Alborz
Postal code
3143744693
Phone
+98 26 3442 7001
Fax
+98 26 3442 6979
Email
Madani@abzums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
راضیه لطفی
Street address
Taleghani Square, North Taleghani Blvd
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3419 7000
Email
info@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Hamid Sohrabian
Position
Resident of orthopaedic surgery
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
AbooAliSina ave, Molana blvd
City
Karaj
Province
Alborz
Postal code
3143653688
Phone
+98 26 3444 3284
Fax
Email
hamiso1988@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Hamid Sohrabian
Position
Resident of orthopaedic surgery
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
AbooAliSina ave, Molana blvd
City
Karaj
Province
Alborz
Postal code
3143653688
Phone
+98 26 3444 3284
Fax
Email
hamiso1988@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Hamid Sohrabian
Position
Resident of orthopaedic surgery
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
AbooAliSina ave, Molana blvd
City
Karaj
Province
Alborz
Postal code
3143653688
Phone
+98 26 3444 3284
Fax
Email
hamiso1988@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All potential data can be shared after de-identifying individuals.
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
The use of documents for research and scientific work is allowed.
From where data/document is obtainable
Applicants should contact the following email to use and receive documents: hamiso1988@gmail.com
What processes are involved for a request to access data/document
In a period of less than a week, the applicants for receiving the documents who contacted by e-mail will be answered and the documents will be provided to them.
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