Proforma to Be Filled by the Principal Investigator (PI) for Submission to Institutional

Proforma to be filled by the Principal Investigator (PI) for submission to Institutional Ethics Committee (IEC)

(for attachment to each copy of the proposal)

Serial No of IEC Management Office:

Proposal Title: “ROLE OF MRI IN THE EVALUATION OF ROTATOR CUFF INJURIES”

Name, Designation
Qualifications / Address
Tel & Fax Nos.
Email ID / Signature
Principal Investigator
Guide / Dr. Utkarsh Kabra
Postgraduate
Dept.of Radiodiagnosis
A.J.Institute of Medical Sciences.
M.B.B.S.
Dr. Gururaj Sharma,
Associate Professor,
Dept. of Radiodiagnosis,
A.J.Institute of Medical Sciences.
M.B.B.S,M.D, D.N.B, / S/O Ranjan Kabra,
A-9 Janta Colony,
Near Adarsh Nagar Police Station,
Jaipur-302004
Ph: +919591042259

Curriculum Vitae of principal investigator and the guide (with subject specific publications limited to previous 5 years)– Attached
1.Type of Study: Prospective
2: Brief description of the proposal:-
Magnetic Resonance Imaging(MRI) the first line of investigation in patients with suspected rotator cuff injuries.It helps in the diagnosis and grading of these lesions so as to accurately guide further management. We propose to sudy the efficacy of MRI imaging in the rotator cuff injuries.
3. Subject selection:

Number of Subjects : 30

Duration of study: 2 years

iii. Will subjects from both sexes be recruited / Yes

Inclusion / exclusion criteria given

/ Yes

Type of subjects:Patients who are suspected to have rotator cuff injuries and referred for MRI Shoulder will be included in the study

4. Privacy and confidentiality
Confidential handling of data : Yes
5. Consent : Please find it attached written informed consent
i. Consent form : (included elements)

Understandable language
Statement that study involves research
Statement that consent is voluntary
Purpose and procedures
Risks & Discomforts
Benefits
Confidentiality of records
Right to withdraw
Contact information

ii. Who will obtain consent – Principal investigator
6. Will any advertising be done for recruitment of Subjects?
(posters, flyers, brochure, websites – if so kindly attach a copy) / No
7. Risks & Benefits: No risks, but benefits to the research world
8. Is there compensation for participation? / No
Checklistforattacheddocuments:

Project proposal – 2 Copies
Curriculum Vitae of Investigators
Curriculum Vitae of Guide
Informed Consent form
Copy of data collection Proforma

Place: Signature & Designation of

Date: Principal investigator

CURRICULUM VITAE

Name : Dr.Utkarsh Kabra

Date of Birth &Age : August 6th 1988 -25years

Present Designation : PG/Junior Resident

Department : Radiodiagnosis

College : A. J. Institute of Medical Sciences

City : Mangalore

Residential address : S/o Ranjan Kabra,A-9 Janta Colony,

Near Adarsh Nagar Police Station,Jaipur-302004

Phone & fax numberwith code: Office: 0141-2570560 Residence:0141-2602600

Email address:

Mobile Number: 9591042259

PAN Number: ATMPK4010D

Qualification:

Qualification / College / University / Year / Registration number of UG & PG with date / Name of the state Medical Council
MBBS / M.S. Ramaiah Medical College,Bangalore / Rajiv Gandhi University
of Health
Sciences / Aug2006

Details of the previous appointments/ teaching experience:

Designation / Department / Name of Institution / From DD/MM/YY / To DD/MM/YY / Total experience in years and months
PG/ Jr. Resident / Radiodiagnosis / A. J. Institute of Medical Sciences, Mangalore / July 05, 2013 / Till Date

CURRICULAM VITAE

Name:DR.GURURAJ SHARMA

Date of Birth & Age: June 5, 1964 (48 years)

Present Designation:Asso.Professor

Department:RADIODIAGNOSIS

College:A.J. Institute of Medical Sciences

City:Mangalore

Residential Address: Flat no.108,1 floor

Mannagudda towers ,

Mannagudda ,mangalore-575 003

Phone & Fax Number : Office :0824-2225533

with code

Residence:

E- Mail id:

Mobile Number : 09900908277

PAN Number :AKCPS8563Q

1. (i)Date of joining Present Institution :March 01,2007 as Associate Professor

Qualifications:

Qualification / College / University / Year / Registration No.of UG & PG with Date / Name of the State Medical Council
MBBS / Goa Medical College / University of Bombay / Dec 1988 / 72176
Dt. Aug12,2005 / Karnataka medical Council
MD(RADIODIAGNOSIS / Goa Medical
College / Goa University / Jan 1991 / 72176 Aug12,2005 / Karnataka Medical Council
DNB / National
Board of Examination,
New Delhi / National
Board of Examination,New Delhi / May
1993 / 72176
Dt,Aug 12,2005 / Karnataka Medical Council

Details of the previous appointments/teaching experience:

Designation / Department / Name of Institution / From
DD/MM/YY / To
DD/MM/YY / Total Experience in years& months
PG resident / Radiodiagnosis / Goa medical college / Mar 19,
1988 / Mar 18,
1991 / 3 years
Assistant Professor / Radiodiagnosis / Kasturba Medical College Manipal / May 20,1991 / May19,
1993 / 2 years
Assistant
Professor / Radiodiagnosis / Kasturba Medical College Manipal / May 20
1993 / May31
1994 / 1 year
Associate
Professor / Radiodiagnosis / A J Institute of Medical College Mangalore / Dec01
2001 / Dec 31
2003 / 2year
1month
Associate
Professor / Radiodiagnosis / A J Institute of Medical College Mangalore / Jan 01
2004 / Dec31
2004 / 1year
Associate
Professor / Radiodiagnosis / A J Institute of Medical College Mangalore / May 01
2007 / Till date

SYNOPSIS

Submission for ethical clearance to Ethical Committee of AJIMS

“ROLE OF MRI IN THE EVALUATION OF ROTATOR CUFF INJURIES”

Name of the candidate: Dr. Utkarsh Kabra

Guide: Dr. Gururaj Sharma

Course and Subject: M.D. Radiodiagnosis

Department of Radiodiagnosis,

A.J. INSTITUTE OF MEDICAL SCIENCES,

Kuntikana, Mangalore – 575004

2013

1. Name of the candidate

& address:

(in block letters)

2. Name of the Institute:

3. Course of study and Subject:M.D.RADIODIAGNOSIS

4. Date of admission to course: 05th July 2013

5. Title of the Topic: “ROLE OF MRI IN THE EVALUATION OF ROTATOR CUFF INJURIES”

BRIEF RESUME OF THE INTENDED WORK:

6.1 Need for the study:

Rotator cuff injuries are fairly common and cause significant pain and morbidity. Imaging is important in the diagnostic work up of such patients to guide the further treatment. MR imaging has emerged as the choice of investigation in most musculoskeletal disorders including the shoulder. Hence, it is important to know the accuracy and limitations of MRI in the evaluation of various rotator cuff injuries.

6.2Review of literature:

Davidson JF et al1concluded that high-quality preoperative MRI can predict

rotator cuff tear pattern and method of repair. This isclinically significant because better appreciation ofbasic tear configuration, crescent-shaped or longitudinal can lead to more preciserestoration of anatomy and biomechanics..

Morag Y et al2 concluded that Magnetic resonance imaging can demonstrate the extent and configuration of rotator cuff abnormalities, suggest mechanical imbalance within the cuff, and document abnormalities of the cuff muscles and adjacent structures. A thorough understanding of the anatomy and function of the rotator cuff and of the consequences of rotator cuff disorders is essential for optimal treatment planning and prognostic accuracy. Identifying the disorder, understanding the potential clinical consequences, and reporting all relevant findings at rotator cuff imaging are also essential.

Kneeland et al3 concluded that MRI has good potential for the non-invasive diagnosis of rotator cuff tears. Its ultimate role in the diagnosis must await prospective studies comparing its accuracy with sonography,ct and arthrography.

.Middleton et al4 concluded that MR offers a real possibility of localising and quantifying abnormalities of cuff with precision.

Patten RM5 concluded that tears of the subscapularis tendon can be identified on MR images as areas of disorganized tendon morphology and abnormal high intensity on T2 weighted images. Abnormalities of the biceps tendon also are seen commonly. When subscapularis tears are recognized, the long head of the biceps tendon should be scrutinized for associated injury or malposition.

Parsa M et al6 concluded that on evaluating the ability of observers to diagnose rotator cuff tears on oblique coronal MR images only, interpretation on T2*-weighted images tended to be less sensitive and specific than interpretation of standard dual-echo T2-weighted images.

6.3Objectives of the study:

Tostudy the diagnostic accuracy of routine MRI in the detection and characterization of rotator cuff injuries.
To assess the role of MRI in guiding treatment decisions such as conservative or surgical.
To correlate the MRI findings with the surgical /arthroscopy findings, wherever possible.
To assess the limitations and pitfalls if any.

7. Material and methods:

Equipment used:Siemens Magnetom Avanto 1.5 T MRI

Source of Data: Hospital based study enrolled for study after obtaining an informed consent. Patients coming to radiology department withsuspected rotator cuff injuries.

Study design: Prospective study

Sample size: 30

Sample: Patients attending AJ Institute of Medical Sciences

Place: A.J. Institute of medical sciences, Mangalore – 575004

Sample and sampling technique: Sample size- 30

Study type: Prospective Study

Inclusion criteria:Patients who are referred for MRI shoulder and are detected to have a rotator cuff injury will be included in the study.

Exclusion criteria:Patients who do not have any findings on MRI will be excluded.

Plan for data analysis:Data will be entered in Microsoft Excel sheet and will be analysed using SPSS version 11.0 statistical software. Data will be depicted in the form of tables and charts. Appropriate statistical tests like Chi Square test and other non parametric tests will be used.

7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so, please describe briefly.

MRI of shoulder will be done on all the patients. There is no injection or intervention involved in this study.

7.4 Has ethical clearance been obtained from your institution in case of 7.3?

Yes

8. References:

1. Davidson JF, Burkhart SS, Richards DP, Campbell SE. Use of preoperative magnetic resonance imaging to predict rotator cuff tear pattern and method of repair. Arthroscopy2005;21(12):1428.

2. Morag Y, Jacobson JA, Miller B, De maeseneer M, Girish G, Jamadar D. MR imaging of rotator cuff injury: what the clinician needs to know. Radiographics 2006;26:1045-1065.

3. Kneeland JB, Middleton WD, Carrera GF, Zeuge RC, Jesmanowicz A, Froncisz W, et al. MR Imaging of the Shoulder: Diagnosis of Rotator Cuff Tears;AJR 1987;149:333-337.

4.Middleton WD, Kneeland JB, Carrera GF, Cates JD, Kellman Gary, Campagna NG, et al. High-Resolution MR Imaging of the Normal Rotator Cuff. AJR1987;148:559-564.

5.Patten RM. Tears of the Anterior Portion of the Rotator Cuff(the Subscapularis Tendon): MR Imaging Findings. AJR 1994;162:351-354.

6. Parsa M, Tuite M, Norris M, Orwin J. MR Imaging of Rotator Cuff Tendon Tears: Comparison of T2*-Weighted Gradient-Echo and Conventional Dual-Echo Sequences. AJR1997;168:1519-1524.

9.Signature of the candidate:

10. Remarks of the guide:

11.Name and Designation of (in block letters):-

11.1 Guide:

11.2 Signature:

11.3Co-Guide:

11.4 Signature:

11.5 Head of Department:

11.6 Signature:

12. Remarks of the Chairman and Principal:

Signature:

TIME PLAN

TITLE: ROLE OF MRI IN THE EVALUATION OF ROTATOR CUFF INJURIES

PHASE / TIME PERIOD / OUTLINE OF PLAN
1 / JULY 2013—DECEMBER2013 / 1.IDENTIFICATION OF PROBLEM
2.REVIEW OF LITERATURE
3.CONDUCTING PILOT STUDY
4.DEVOLPMENT OF PROFORMA
5.SUBMISSION OF SYNOPSIS
2. / DECEMBER2013-DECEMBER 2015 / 1.ENROLLMENT
2.DATA COLLECTION
3.FOLLOW UP
3. / JANUARY2015 - JUNE 2016 / ANALYSIS OF COLLECTED DATA
4. / JUNE 2016-NOVEMBER 2016 / 1.DISCUSSION
2.PUBLICATION

Written Informed Consent Form

A J INSTITUTE OF MEDICAL SCIENCES,

KUNTIKANA, MANGALORE.

Informed consent form for the volunteers at “A J Institute of Medical Sciences, Kuntikana, Mangalore”, who will be participating in the research project (MD dissertation) entitled: “MRI OF ROTATOR CUFF INJURIES AND THEIR CLINICAL CORRELATION”

Name of Principal Investigator: / Dr. Utkarsh Kabra,
Postgraduate,
Name of Organization: / Department of,RADIODIAGNOSIS
A J Institute of Medical Sciences, Kuntikana, Mangalore.

This Informed Consent Form has two parts:

Information Sheet (to share information about the research with you)
Certificate of Consent (for signatures if you agree to take part)

You will be given a copy of the full Informed Consent Form

PART I: Information Sheet

Introduction:

I, Dr. Utkarsh Kabra, postgraduate student in the Department of Radiodiagnosis, A J Institute of Medical Sciences, Kuntikana, Mangalore, working on my MD dissertation titled”. “ROLE OF MRI IN THE EVALUATION OF ROTATOR CUFF INJURIES”

I am going to give you information and invite you to be part of this research. You do not have to decide today whether or not you will participate in the research. Before you decide, you can talk to anyone you feel comfortable with about the research.

There may be some words that you do not understand. Please ask me to stop as we go through the information and I will take time to explain. If you have questions later, you can ask them and get yourself clarified.

Purpose of the research: -

Rotator cuff injuries are fairly common and cause significant pain morbidity. MRI

is the choice of investigation in such cases. Hence, the diagnosis of an injury and its grading by MRI is important for further management. The degree to which an MRI can accurately pick up such injuries is very important.

Type of Research Intervention:

MRI of the shoulder joint.

Participant selection: Patients presenting to the department of radiodiagnosis with shoulder pain and suspected rotator cuff injuries will be included in the study

Procedures and Protocol:

MRI would be done for all the participants.

Voluntary Participation:

Your participation in this research is entirely voluntary. It is your choice whether to participate or not. Whether you choose to participate or not, it will not affect your patient’s treatment process.

Benefits

Personally you might be or may not be benefited in any way directly from the research. But by taking part in this research, you will be helping the scientific community to learn more about the “ROLE OF MRI IN THE EVALUATION OF ROTATOR CUFF INJURIES” and increasing the definitive therapy and reducing the burden for other invasive and higher costly mode of imaging to the other population

Reimbursements

You won’t be given any monetary incentives or gifts for being a part of this research.

Confidentiality

The information that we collect from this research project will be kept confidential. Information about the patient that will be collected during the research will be put away and no-one but the researchers will be able to see it. Any information about the patient will have a number on it instead of your name.

Sharing the Results

The knowledge that we get from doing this research will be shared with you. Confidential information will not be shared. We will publish the results in order that other interested people may learn from our research.

Right to Refuse or Withdraw

You do not have to take part in this research if you do not wish to do so. You may also stop participating in the research at any time you choose. It is your choice and all of your rights will still be respected.

Who to Contact

This proposal has been reviewed and approved by the Research and Ethical committee of A J institute of Medical Science, Kuntikana Mangalore, which is a committee whose task it is to make sure that research participants are protected from harm. You may contact the following member of the Institute Ethics committee for more details

Dr.UTKARSH KABRA -9591042259

Dr. GURURAJ SHARMA

You can ask me any more questions about any part of the research study, if you wish to. Do you have any questions?

PART II: Certificate of Consent

I have read the foregoing information, or it has been read to me. I have had the opportunity to ask questions about it and any questions that I have asked have been answered to my satisfaction. I consent voluntarily to participate as a participant in this research.

Name of Participant______

Signature of Participant ______

Date ______

Day/month/year

If illiterate a literate witness must sign (if possible, this person should be selected by the participant and should have no connection to the research team). Participants who are illiterate should include their thumb-print as well.

I have witnessed the accurate reading of the consent form to the potential participant, and the individual has had the opportunity to ask questions. I confirm that the individual has given consent freely.

Name of witness______Thumb print of participant

Signature of witness ______

Date ______

Day/month/year

Statement by the researcher/person taking consent

I have accurately read out the information sheet to the potential participant, and to thebest of my ability made sure that the participant understands that the following will be done:

MRI SHOULDER

I confirm that the participant was given anopportunity to ask questions about the study,and all thequestions asked by the participant have been answered correctly and to the best of my ability. I confirm that the individual has not been coerced into giving consent, and the consent has been given freely and voluntarily.

A copy of this informed consent form has been provided to theparticipant.

Name of Researcher/person taking the consent______

Signature of Researcher /person taking the consent______

Date ______

Day/month/year

Proforma

Name :

Age/Sex :

Address :

Hospital No.:

MRI Findings:

a)Partial/complete tear

b)Bone involvement

c)Joint effusion

d)Other

Treatment :

a)Conservative

b)Arthroscopy

c)Other