1. Home
  2. Approved trials
  3. » فارسی

Comparative results of bioabsorbable screw and endobutton femoral fixation of bone patellar tendon bone graft for Anterior cruciate ligament reconstruction

Protocol summary

Study aim
Evaluation results of bioabsorbable screw and endobutton femoral fixation of bone patellar tendon bone graft for Anterior cruciate ligament reconstruction
Design
This study is clinical trial and double blind. 42 patients candidate Anterior cruciate ligament reconstruction in Valiasr hospital and Amiralmomenin hospital will inter this study. We will divide patients in 2 groups by simple randomization. Groups are parallel.
Settings and conduct
42 patients candidate Anterior cruciate ligament reconstruction in Valiasr hospital and Amiralmomenin hospital in Arak will inter this study.This study is double blind. Outcome assessor and analyzer not aware from grouping. Codes of group are available to analyzer and outcome assessor. We record physical problems of the knee, objective and subjective surgical outcomes.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Over 15 years old, candidate for surgical reconstruction of cruciate ligament, anterior cruciate ligament rupture that has no history of previous surgery on the knee, the knee of the leg is correct, anterior cruciate ligament rupture is confirmed by a clinical examination and MRI Exclusion criteria: Dissatisfaction, patients who have suffered from knee surgery, psychiatric patients or severely addicted patients
Intervention groups
Intervention group 1: We will do surgery patients with endobutton femoral fixation. Intervention group 2: We will do surgery patients with bioabsorbable screw femoral fixation.
Main outcome variables
Physical problems of the knee, objective and subjective surgical outcome

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190508043524N1
Registration date: 2019-08-11, 1398/05/20
Registration timing: registered_while_recruiting

Last update: 2019-08-11, 1398/05/20
Update count: 0
Registration date
2019-08-11, 1398/05/20
Registrant information
Name
Arsham Jangmiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
arshamjangmiri@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-16, 1397/09/25
Expected recruitment end date
2020-03-15, 1398/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative results of bioabsorbable screw and endobutton femoral fixation of bone patellar tendon bone graft for Anterior cruciate ligament reconstruction
Public title
Comparative results of bioabsorbable screw and endobutton femoral fixation of bone patellar tendon bone graft for Anterior cruciate ligament reconstruction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Over 15 years old Candidate for surgical reconstruction of cruciate ligament Anterior cruciate ligament rupture that has no history of previous surgery on the knee The knee of the leg is correct. Anterior cruciate ligament rupture is confirmed by a clinical examination and MRI
Exclusion criteria:
Dissatisfaction Patients who have suffered from knee surgery. Psychiatric patients or severely addicted patients
Age
From 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 42
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with randomization with envelopes in two groups A and B. In this method, we selected a number of cards or letters as an intervention and the same ‎number of cards for the control group, then the cards were merged. One card was taken out and its ‎allocation was registered and the card was returned to the other cards after leaving. Then the cards ‎are merged again and we remove another card. This process continues to reach a random sequence ‎according to sample size.‏
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind. Researcher who complete questionnaire and analyzer and participant are blind (double blind). Outcome assessor and analyzer don't aware from grouping.The person evaluating the outcome is unaware of the grouping. Groups A and B are available to analyzer and outcome assessor
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences
Street address
Vice chancellor for research, Payambar azam complex, Basij squre, Sardasht, A
City
Arak
Province
Markazi
Postal code
38149578558
Approval date
2018-12-12, 1397/09/21
Ethics committee reference number
IR.ARAKMU.REC.1397.211

Health conditions studied

1

Description of health condition studied
Anterior cruciate ligament reconstruction
ICD-10 code
M23.61
ICD-10 code description
Other spontaneous disruption of anterior cruciate ligament of knee

Primary outcomes

1

Description
Physical problems of the knee
Timepoint
Before surgery and 12 months after surgery
Method of measurement
lysholm score

2

Description
objective surgical outcome
Timepoint
Before surgery and 12 months after surgery
Method of measurement
KDLC score

3

Description
Subjective surgical outcome
Timepoint
Before surgery and 12 months after surgery
Method of measurement
KDLC score

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1:We will do surgery patients with endobutton femoral fixation .
Category
Treatment - Surgery

2

Description
Intervention group 2:We will do surgery patients with bioabsorbable screw femoral fixation .
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Dr Hosseinali Hadi
Street address
Valiasr hospital, Valiasr squre, Arak
City
Aak
Province
Markazi
Postal code
38149578558
Phone
+98 86 3222 2003
Email
hadi@arakmu.ac.ir

2

Recruitment center
Name of recruitment center
Amiralmomenin hospital
Full name of responsible person
Dr Hosseinali Hadi
Street address
Amiralmomenin hospital, Sardasht
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
hadi@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Arjmandzadegan
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Email
arjmandzadegan@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Hosseinali Hadi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Shahid Shirodi street, Valiasr square, Valiasr hospital
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
hadi@arakmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Hosseinali Hadi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Shahid Shirodi street, Valiasr square, Valiasr hospital
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
hadi@arakmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Arsham Jangmiri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Shahid Shirodi street, Valiasr square, Valiasr hospital
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
Email
arshamjangmiri@yahoo.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
When we publish article in journal
When the data will become available and for how long
After the article is published
To whom data/document is available
researcher in university
Under which criteria data/document could be used
If there are additional questions
From where data/document is obtainable
Dr Hadi Valiasr Hospital, Valiasr squre, Shahid Shirodi street 3814957558
What processes are involved for a request to access data/document
Contact With Dr Hadi at the following email address. Hadi@arakmu.ac.ir
Comments
Loading...