From: Dr.K.Sunil Kumar Post Graduate in Orthopaedics (M.S.

Orthopaedics), Institute of Orthopaedics and Traumatology, Madras Medical College and Rajiv Gandhi Government General Hospital, Chennai-600003.

To: The Chairman, Institutional Ethical Committee (IEC), Madras Medical College and Rajiv Gandhi GovernmentGeneral Hospital, Chennai-600003.

THROUGH PROPER CHANNEL Respected Sir/Madam, Sub: Request for approval from the Institutional Ethical Committee to conduct a prospective study on functional outcome of skeletal stabilization in pathological fractures. I have proposed to work on Functional outcome analysis of skeletal stabilization in pathological fractures. - Short term prospective study As this study involves human beings, I request an approval from the ethical committee. I am enclosing the details of the study work. I am also submitting the following undertaking, 1. I will get the detailed informed consent from the patients/participants and maintain confidentiality. 2. I will carry out the work without being to detrimental to regular activities as well as without extra expenditure to the institution or the government. 3. I will inform the committee in case of any change in the study procedure, site, and investigation or guide. 4. I will not deviate from the area of work for which I have applied for ethical clearance. 5. I will inform the IEC committee in case of serious adverse reactions.

6. I will abide by the rules and regulations of the institution. 7. I will complete the work within the specified period I applied for if any extension of time is required, I shall apply for permission again and do the work. 8. I will submit the summary of the work to the ethical committee or on completion of the work. 9. I will not claim funds from the institution while doing the work or on completion. 10. I understand that the members of IEC have the right to monitor the work with prior intimation. 11. I am enclosing ten copies of the study proposal for perusal. 12. I have paid the sum of Rs. 200/-towards processing fees.

Thanking you, Yours sincerely (Dr.K.Sunil Kumar)

Guide & Co-coordinator :

PROF.N.Deen Muhammad Ismail M.S Ortho, D.Ortho Director and HOD I/C Institute of Orthopaedics and Traumatology, Rajiv Gandhi Government General Hospital, Chennai - 3

Remarks of the guide This is the work to be done by Dr.K.SUNIL KUMAR on patients with pathological

fractures treated with skeletal stabilization is done under my supervision and I ensure that candidate will abide by the rules of ethical committee.

PROF.N.Deen Muhammad Ismail M.S Ortho, D.Ortho Director and HOD I/C Institute of Orthopaedics and Traumatology Government General Hospital,Chennai-3.

In recommendation from Director This is the work to be done by DR.K.SUNIL KUMAR on patients with pathological fractures treated with skeletal stabilization is done under my supervision and I ensure that candidate will abide by the rules of ethical committee.

PROF.N.Deen Muhammad Ismail M.S Ortho, D.Ortho Director and HOD I/C Institute of Orthopaedics and Traumatology Government General Hospital,Chennai-3.

PROTOCOL PRESENTATION
Primary investigator: DR.K.SUNIL KUMAR Post graduate Institute of Orthopaedics and Traumatology Rajiv Gandhi Government General Hospital,Chennai-3

Supervisor& guide :

PROF.N.Deen Muhammad Ismail M.S Ortho, D.Ortho Director and HOD I/C Institute of Orthopaedics and Traumatology Government General Hospital,Chennai-3.

Title of study :

Functional outcome analysis of pathological fractures

treated with skeletal stabilization. A Short term prospective study. Design of study: Prospective cohort study

Proposed Period of study:

June 2012 to Dec 2014

Ethical clearance: Consent:

Applied Informed consent from all patients will be obtained

Aim and objective:

To analyse the functional outcome analysis of pathological fractures treated with skeletal stabilization

Materials:

This is a prospective clinical study where patients of pathological fractures admitted in our Institute of

orthopaedics and traumatology are treated with skeletal stabilization.

Inclusion criteria: Age >18 years . Closed fractures.

Exclusion criteria: Age < 18 years. Open injuries Extensive soft tissue injury with healing period more than 2 weeks

Method Patients presenting with pathological fractures are treated with skeletal stabilization and postoperatively the patients are to be followed up for the outcome using standard scoring systems. Analysis: Data will be analysed using standard statistical methods

PATIENT CONSENT FORM STUDY TITLE: functional outcome analysis of pathological fractures treated with skeletal stabilisation A Short term prospective study

STUDY CENTRE:

Institute of Orthopaedics and Traumatology Rajiv Gandhi Govt. General Hospital and Madras Medical College, Chennai-3

Patients Name Patients Age Identification Number

:_____________________________________ :_____________________________________ :_____________________________________

I confirm that I have understood the purpose and procedure for the above study. I have the opportunity to ask the question and all my questions and doubts have been answered to my complete satisfaction. I understand that my participation in the study is voluntary and that I am free to withdraw at any time without giving any reason, without my legal rights being affected. I understand that the sponsor of the clinical study, others working on the sponsors behalf, the ethics committee and the regulatory authorities will not need my health records both in respect of the current study and any further research that may be conducted in relation to it, even if I withdraw from the study. I agree to this access. However, I understand that my identity will not be revealed in any information released to third parties or published, unless as required under the law. I agree not to restrict the use of any data or results that arose from this study. I agree to take part in the above study and to comply with the instructions given during the study and to faithfully Co-operate with the study team, and to immediately inform the study staff if I suffer from any deterioration in my health or well being or any unexpected or unusual symptoms. I hereby consent to participate in this study of Functional outcome analysis of skeletal stabilization in pathological Fractures.- A Short term prospective study I hereby give permission to undergo complete clinical examination, and diagnostic tests including hematological, biochemical, radiological, urine examination. Signature / Thumb impression ____________________Place____________Date _________ Of the patient. Patients Name &Address: _____________________________________________________ ____________________________________________________________________________ Signature of the Investigator: _____________________ Place___________Date __________ Study Investigators Name: _____________________________________________________

PATIENT CONSENT FORM IN TAMIL