RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA
SYNOPSIS FOR REGISTRATION OF SUBJECT FOR DISSERTATION
TITLE OF THE TOPIC
“ANTHROPOMETRIC MEASUREMENTS OF MEDIAL AND
LATERAL MALLEOLI FOR BETTER DESIGN OF IMPLANTS
AND SURGICAL RESULTS”
Dr. SHAMIKH MUNEER GHAUS -UL RAZA
P.G. M.S. ORTHOPAEDICS,
AL-AMEEN MEDICAL COLLEGE,
BIJAPUR RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
Dr. SHAMIKH MUNEER GHAUS-UL RAZA NAME OF THE CANDIDATE AND Maulana Azad boys junior hostel R. No. 29 01 ADDRESS: Al-Ameen Medical College, Bijapur
02 NAME OF THE INSTITUTION: AL-AMEEN MEDICAL COLLEGE, BIJAPUR – 586 108, KARNATAKA
03 COURSE OF STUDY AND SUBJECT: M.S. (ORTHOPAEDICS)
04 DATE OF ADMISSION TO COURSE: May 2009
“ANTHROPOMETRIC 05 TITLE OF THE TOPIC: MEASUREMENTS OF MEDIAL AND LATERAL MALLEOLI”
06 BRIEF RESUME OF THE INTENDED WORK:
6.1 NEED FOR THE STUDY: VIDE ANNEXURE – I
6.2 REVIEW OF LITERATURE : VIDE ANNEXURE – II
6.3 OBJECTIVES OF THE STUDY : VIDE ANNEXURE – III
07 MATERIAL AND METHODS :
7.1 SOURCE OF DATA : VIDE ANNEXURE – IV
2 7.2 METHOD OF COLLECTION OF DATA VIDE ANNEXURE – IV (INCLUDING SAMPLING PROCEDURE, IF ANY ):
7.3 DOES THE STUDY REQUIRE ANY VIDE ANNEXURE – IV INVESTIGATIONS OR INTERVENTIONS TO BE CONDUCTED ON PATIENTS OR OTHER HUMAN ANIMALS? IF SO PLEASE DESCRIBE BRIEFLY:
VIDE ANNEXURE – V 7.4 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.3: YES (Certificate has been enclosed here with)
7.5 SAMPLE INFORMED CONSENT VIDE ANNEXURE – VI FORM:
08 LIST OF REFERENCES: VIDE ANNEXURE – VII
09 DIAGRAMS TO EXPLAIN STUDY VIDE ANNEXURE – VIII
10 SIGNATURE OF THE CANDIDATE :
11 REMARKS OF THE GUIDE : THIS IS A RELEVANT CLINICAL STUDY. IT HELPS IN THE BETTER PROSTHETIC AND ORTHOTIC FITMENTS
12 NAME AND DESIGNATION OF:
DR. M.S. PATIL, M.S. (ORTHOPAEDICS) 12.1 GUIDE: PROFESSOR DEPARTMENT OF ORTHOPAEDICS
12.2 SIGNATURE:
3 12.3. CO-GUIDE DR. M.N. KOTI, M.S. (ANATOMY) PROFESSOR & H.O.D. DEPARTMENT OF ANATOMY
12.4. SIGNATURE
12.5. HEAD OF DEPARTMENT DR. A. H. SASNUR, M..S. (ORTHOPAEDICS) PROFESSOR & H.O.D. DEPARTMENT OF ORTHOPAEDICS
12.6. SIGNATURE
13 13.1 REMARKS OF THE DEAN ALL THE HELP NECESSARY FOR THE CONDUCT OF THIS STUDY WILL BE PROVIDED
13.2 SIGNATURE
ANNEXURE – I
6.1 NEED FOR THE STUDY:
Fractures around the ankle including malleolar fractures and pilon fractures have shown a remarkable increase in recent times. This has been brought about by the increasing number of motorcycles on the roads resulting in high velocity trauma causing not only comminuted fractures but also soft tissue trauma.
4 Management of bimalleolar fractures has shifted from conservative management to better operative management with our improved understanding of the mechanism of injury of these fractures. Debate still continues on whether to give more importance to the lateral malleolus or the medial malleolus while dealing with such injuries. However, we know that the ankle mortise should be well reconstructed with getting the talus in its proper alignment with the tibial plafond, restoration of the fibular length and proper fixation of the medial malleolus to maintain its correct tilt. Parameters like the talo-crural angle, tibiofibular overlap, talo malleolar joint space, etc have gained importance and are vital for obtaining good results of fixation1.
For proper maintainance of the fibular length contoured plates are ideal. Contouring is essential to avoid a varus or valgus positioning of the lateral malleolar fragment thus compromising the ankle mortise. An understanding of the curvatures of the lateral malleolus is essential for contouring. Similarly proper tilt of the comminuted, medial malleolar fragment has to be restored. This is especially important for pilon fractures fixed with contoured plates by the MISS technique.
Anthropometric studies on the medial surface of lower end of tibia and lateral and posterior surface of the lower end of fibula are important in this regard. There is sparse knowledge in world literature on this aspect.
The current study will be based on assessment of AP Mortise views of 50 volunteers. Measurement of various angles subtended by the curving medial surface of lower end of Tibia and lateral surface of lower end of fibula will also be undertaken in 50 cadaveric fibula and tibia obtained from the Anatomy Departments and from Medical Students.
ANNEXURE – II
6.2 REVIEW OF LITERATURE
There is very little work in International Literature on the anthropometry of the medial and lateral malleolus. Anthropometric studies on the ankle joint have, however, been carried out from time to time. Isman and Inman (1969) 2 did a landmark study to determine the axis of the talocrural (ankle) and talocalcaneal (subtalar) joints. They concluded that both 5 joints can be considered to be single axis joints for the purpose of prosthetic and orthotic fitments.
Pettrone et al (1983) 3 came up with various criteria for prediction of results of displaced fractures of the ankle. They pointed out the landmarks for assessment of syndesmotic injuries.
Recently Raza and Rastogi (2007) 4 have done anthropometric studies on the lateral .malleolus. They have made detailed assessment of the lateral and posterior surfaces of cadaveric fibula and have suggested certain angles in AP and lateral radiographs for contouring of plates for fixation of lateral malleolar fractures.
Classification of Ankle Injuries: The Lange-Hansen classification of ankle injuries was first published in 1950 5. It gives an understanding of the position of the foot and direction of action of the force to which it was subjected to. Recently, the Danis-Weber classification (or the AO classification) has also been introduced based on the position of the fibular fracture in relation to the lateral malleolus. The AO classification system elaborates on the Danis-Weber classification by incorporating medial malleolar fractures.
Till date there has not been a single study to evaluate the usefulness of anthropometric studies of the lateral and medial malleolus in planning reconstructions of the ankle mortise, or to assess the treatment given (conservative/operative), or to assess factors responsible for favorable or bad results.
ANNEXURE – III
6.3 OBJECTIVES OF THE STUDY
1. To study various parameters like the anthropometric measurements of both the malleoli on the radiographs as well as on cadeveric bones (tibia & fibula).
6 2. Use the above results for making recommendations for the design and manufacture of implants (especially plates) for use over the medial & lateral malleoli for better surgical results.
ANNEXURE – IV
MATERIAL AND METHODS:
7.1 . SOURCE OF DATA:
50 volunteers randomly selected in Al Ameen Medical College, Bijapur, having no ankle abnormalities or deformities in both the ankles. 7.2 METHOD OF COLLECTING DATA: 7 The study will be carried out in two parts:
1. Measurement on AP Mortise view of both ankles of 50 volunteers. (after obtaining due consent from them). 2. Measurements of lower ends of 50 cadaveric fibula and tibia each.
a. AP mortise view of both ankles will be obtained using the standard projections. Two angles on the medial side at a point maximum medial curve on the medial cortex of Tibia (approximately 4.5mm above the ankle joint, and a point at the level of the medial malleolus showing a downward and lateral tapering of the Cortex to the tip) will be measured. Similarly three angles marking the curves of the lateral cortex of lower end of fibula will be measured.
The talo-crural angle will be measured as also the difference in levels of the tips of medial and lateral malleoli.
b. These measurements will be carried out on 50 cadaveric Tibia and fibula also for comparison on differences in radiographic projections and cadaveric measurements. All measurements obtained will be subjected to statistical analysis. 7.3 DOES THE STUDY REQUIRE ANY INVESTIGATIONS OR INTERVENTIONS TO BE CONDUCTED ON PATIENTS OR OTHER HUMAN ANIMALS? IF SO PLEASE DESCRIBE BRIEFLY:
.1 X ray of both the ankle of an individual in AP Mortise view.
ANNEXURE – V
ETHICAL COMMITTEE
The following study entitled “ANTHROPOMETRIC MEASUREMENTS OF MEDIAL
AND LATERAL MALLEOLI” by Dr. Shamikh Muneer Ghaus-Ul Raza P.G. student in
8 M.S.(Orthopaedics),2009 batch has been cleared from the ethical committee of this
institution for the purpose of dissertation work.
Date: Chairman,
Ethical Committee,
Al- Ameen Medical College,
Bijapur
ANNEXURE – VI
7.5 SAMPLE INFORMED CONSENT FORM
RESEARCH INFORMED CONSENT FORM
9 TITLE OF THE STUDY:- “ANTHROPOMETRIC MEASUREMENTS OF MEDIAL AND LATERAL MALLEOLI” PRINCIPAL INVESTIGATOR: Dr. SHAMIKH MUNEER GHAUS-UL RAZA
P.G. GUIDE’S NAME: DR. M.S. PATIL
PURPOSE OF STUDY I have been explained about the reason for doing the study and selecting me as a subject of this study. This study is for better understanding of the ankle joint and medial and lateral malleolus.
RISKS AND DISCOMFORTS
I understand that I will be exposed to Two or Three x-ray films of my ankle joints. The risks of this radiation has been explained to me.
BENEFITS
I have been informed that I am a volunteer for this study and there will be no personal benefits to me. I agree to be a volunteer for this study.
CONFIDENTIALITY: I understand medical information produced by this study will become part of my hospital record and will be subject to the confidentiality and privacy regulations of the hospital. If the data are used for publication in the medical literature for teaching purposes, no names will be used, and other identifiers, such as photographs and audio or videotapes, will be used only with my special written permission. I understand I may see the photographs and videotapes and hear the audio tapes before giving this permission. For this purpose every effort will be made by publishing person to contact me in the address furnished by me through postal communication. If no response is received within a reasonable time, all the identities will be removed from the photographs and case report before being submitted for publication.
REQUEST FOR MORE INFORMATION: I understand that, I may ask more questions about the study at any time. Researcher is available to answer my questions or concern in this research period. I understand that this will be a single time investigation and I will not be requested to subject myself to further radiological surveys.
REFUSAL OR WITHDRAWAL OF PARTICIPATION: I understand that my participation is voluntary and I may refuse to participate or discontinue participation in the study at any time without prejudice to my present or future care at this hospital. I also understand that researcher may terminate my participation in the study at any time after I have been explained the reasons for doing so.
INJURY STATEMENT
10 I understand that in the unlikely event of injury to me resulting directly from my participation in this study. If such injury were reported promptly, then medical treatment would be available to me, but no further compensation would be provided. I understand that my agreement to participate in the study I am not waiving any of my legal rights. I have explained to ______
(Patient’s Name) The purpose of research, the procedures required and the possible risk and benefits to the best of my ability.
------Investigator : Dr. SHAMIKH MUNEER GHAUS-UL RAZA Date: I have been explained clearly about the reason for doing this study, reason for selecting me as a subject in the study. I also have been explained about the risks, benefits and confidentiality of the study. Freedom is given to me for the participation in the study or discontinues participation at any time without prejudice. All the above explained in detail to me clearly in my own language. I am giving consent voluntarily for inclusion of me in the study as a subject.
Participant Date: ------
Witness to signature
PROFORMA No.1 FOR M.S. (ORTHOPAEDIC) THESIS
“ANTHROPOMETRIC MEASUREMENTS OF MEDIAL AND LATERAL MALLEOLI”
Name of Candidate: Dr. SHAMIKH MUNEER GHAUS-UL-RAZA
Name of Guide: DR. M.S. PATIL
Serial No: Date of Study: 11 I . CADAVERIC:
Source of Sample Bone: DEPT. OF ANATOMY / MEDICAL STUDENT.
Name : ______
LATERAL MALLEOLUS / MEDIAL MALLEOLUS:
SIDE: ( R) ( L) SEX OF BONE: (if known) Male/Female
LATERAL MALLEOLUS:
A : GROSS MEASUREMENTS: a. Length (From top of facet for talus to the tip): b. Width in sagittal plane: c. Width in coronal plane: B .RADIOLOGICAL ASSESSMENT. (As in accompanying figure). a. Angle A’ : b. Angle B’ : c. Angle C’ : d. Angle D’ : MEDIAL MALLEOLUS A : GROSS MEASUREMENTS: a. Length (From tibial plafond to tip); b. Width in sagittal plane: c. Width in coronal plane:(just below tibial plafond): B. RADIOGRAPHIC MEASUREMENTS: a. Angle A: b. Angle B: c. Angle C: d. Angle D: Necessary photographs obtained: Yes/No. Code Nos:
SIGNATURE OF INVESTIGATOR
PROFORMA No.2 FOR M.S.(ORTHOPAEDIC) THESIS “ANTHROPOMETRIC MEASUREMENTS OF MEDIAL AND LATERAL MALLEOLI” Name of Candidate: Dr. SHAMIKH MUNEER GHAUS-UL-RAZA Name of Guide: Dr. M.S. PATIL Serial No. Name of Volunteer: Address:
12 Contact Phone No. Mobile No. Date of taking Radiographs: MEASUREMENTS ON STANDARD MORTISE VIEW RADIOGRAPHS OF ANKLE JOINT 6 (As per diagram attached with Synopsis) (Adapted from Bruening et al) 7 RIGHT LEFT 1.WIDTH OF ANKLE a. At tibial plafond b. At maximum width (Level in relation to tibial plafond) 2. (a) Talocrural angle (b) Tibiofibular overlap (c) Clear space 3. Medial Malleolus (a) Angle A (b) Angle B (c) Angle C (d) Angle D 4. Lateral Malleolus (a) Angle A’ (b) Angle B’ (c) Angle C’ (d) Angle D’
Length of Lateral malleolus from level of Tibial Plafond.: Length of Medial Malleolus :
Clinical Photographs obtained: Yes/No.
Signature of Investigator
ANNEXURE – VII
LIST OF REFERENCES (BIBLIOGRAPHY)
13 1. Ziran BH & Shuler F.D. Ankle Fractures & Ankle Fracture Dislocations in
Fractures: Diagnosis and Treatment – Mochring, H.D and Greemspa, Adani : Mc
Graw-Hill.2000. 185-196.
2. Isman & Inman, V.T – Bull. Prosthet. Res-Spring 1969 , 97-129.
3. Pettrone FA, Gail M, Pec D, et al: Quantitative criteria for prediction of the results
after displaced fracture of the ankle. J.Bone Joint Surg. 1983 65A: 667-677.
4. Raza H. K.T. & Rastogi, D (2007): Personal communication.
5. Lange-Hansen M 1950 Fractures of the Ankle-II Combined experimental – surgical
and experimental-roentegeno logic investigations. Archives of Surgery 60:957
6. Hohn,T, Palmer P.E.S., Lehtinen, E. 1986, 232-233. Manual of Radiographic
Technique: WHO Basic Radiological System.
7. Bruening D A, Crewe, A.N., Buczetz F L, A simple, anatomically based correction
to the conventional Ankle joint center. Downloaded from Internet.
VIDE ANNEXURE – VIII
14 15