RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA



Rajiv Gandhi University of Health Sciences, Bangalore,

Karnataka

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Synopsis of Dissertation

“Role of Fibular fixation in Distal Third Tibia-Fibula fracture treated with Intramedullary Interlocking nail”

Submitted by

Dr. PRASHANTH NAIK, MBBS

POST GRADUATE STUDENT IN ORTHOPAEDICS

Under the guidance of

Dr. CHIDENDRA. M. SHETTAR

PROFESSOR & UNIT HEAD,

DEPARTMENT OF ORTHOPAEDICS,

SDMCMSH, DHARWAD.

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|RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA |

|BANGALORE. |

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|ANNEXURE – II |

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|PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION |

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|1. |NAME OF THE CANDIDATE AND ADDRESS |DR. PRASHANTH NAIK |

| | |ROOM NO. 435, ASHWATHA PG HOSTEL, |

| | |SDM COLLEGE OF MEDICAL COLLEGE AND HOSPITAL, |

| | |DHARWAD- 580009 |

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|2. |NAME OF THE INSTITUTION |SDM COLLEGE OF MEDICAL SCIENCES & HOSPITAL, |

| | |DHARWAD- 580009 |

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|3. |COURSE OF THE STUDY AND |M.S. ORTHOPAEDICS. |

| |SUBJECT | |

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|4. |DATE OF ADMISSION TO THE COURSE |05-06-2013 |

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|5. |TITLE OF THE TOPIC |“Role of Fibular fixation in Distal Third Tibia-Fibula fracture treated with |

| | |Intramedullary Interlocking nail” |

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|6. |BREIF RESUME OF THE INTENDED WORK: |

| |6.1 Need for the study: Lack of conclusive evidence on role of fixation of fibula in distal third tibial fractures |

| |Being subcutaneous in location, the tibia is the commonest bone to be fractured and is seen commonly in orthopaedic practice. Open fractures |

| |are more common, because one third of its surface is subcutaneous throughout most of its length. Furthermore, the blood supply to the tibia is|

| |more precarious than that of bones enclosed by heavy muscles. The presence of hinge joints at the knee and ankle allows no adjustment for |

| |rotatory deformity after a fracture. Delayed union, non-union and infection are relatively frequent complications especially after open |

| |fractures of the shaft of tibia.Due to its frequency, topography and mode of injury it has become a major source of temporary disability and |

| |morbidity. The major goal in the treatment of fracture tibia is achieving functionally useful and stable extremity. Yet the spectrum of |

| |injuries to tibia is so great that no single method of treatment is applicable to all fractures. |

| |Intramedullary interlocking nailing is a technique which allows stable reduction, maintenance of reduction and allows early mobilization. |

| |Intramedullary interlocking nail is advantageous over other surgical methods as it preserves the soft-tissue sleeve around the fracture site, |

| |the periosteum is not disturbed, and being a closed procedure there is no disturbance of fracture hematoma, with less incidence of infection. |

| |The ability to lock the nails proximally and distally provides control of length, alignment, and rotation in unstable fractures and permits |

| |stabilization of fractures located below the tibial tubercle or 3 to 4 cm proximal to the ankle joint1. Complications like long period of |

| |immobilization, incidence of muscle wasting and stiffness of joint due to treatment with plaster immobilization and external fixator |

| |application is reduced with the use of intramedullary interlocking nail. |

| |For a combined distal tibia and fibula fracture, there exists a debate among surgeons as to whether or not fibular fixation is required as an |

| |adjuvant to IM nailing. Some authors have demonstrated that spiral fractures of the distal tibia treated with IM nailing have a tendency |

| |toward malalignment2,3, and some biomechanical data support this notion4. Conversely, a retrospective study of 157 combined open tibia and |

| |fibula fractures showed that, regardless of the fracture level, fibular fixation did not offer any advantage when compared with standard IM |

| |nailing5. |

| |Presently, there is no clear consensus on the optimum management of combined distal third tibia and fibula fractures. Our objective was to |

| |determine whether combined distal third tibia and fibula fractures are more stable when fibular fixation is added to the standard tibial IMIL |

| |nail. |

| |Hence the study. |

| |6.2 REVIEW OF LITERATURE; |

| |Bernardino de Sahagun, a 16th century anthropologist who travelled to Mexico with Hernando Cortes, recorded the first account of the use of an|

| |intramedullary device. He witnessed Aztec physicians placing wooden sticks into the medullary canals of patients with long bone non unions. |

| |Kuntscher is the father of reamed intramedullary nailing. In 1950 he developed the technique of medullary reaming and closed insertion of an |

| |intramedullary nail without exposing the fracture1. |

| |The dominant design during 1970s and 1980s was the slotted cloverleaf-shaped interlocked nail, e.g., the AO and Grosse-Kempf nails. |

| |Gerhard B.G.Kuntscher (1958) opined that intramedullary nailing represents the ideal treatment of fractures and requires no external fixation |

| |or special postoperative care. The basic principle in this method is stable osteosynthesis through flexible impingement of nail in the bone6. |

| |Klemm and Schelmann in 1972, made the interlocking design following which in 1974, Grosse and Kempf from France invented the G.K. interlocking|

| |nail. |

| |Johner and Wruh (1983) classified tibial fractures based on etiology, morphology and clinical features, documented in a series, 291 fractures |

| |treated by AO/ASIF rigid internal fixation. The fractures were placed in 9 main fracture groups, each with three sub-groups according to |

| |location in the proximal, middle or distal segment of the shaft. Group A includes all simple fractures, Group B includes fractures with |

| |butterfly fragments and Group C all communited. They also developed criteria for evaluation of final results as excellent, good, fair, or poor|

| |by using non-union, pain, deformity, movements of joints, shortening, neurovascular disturbances and gait as parameters for evaluation7. |

| |Court Brown et al (1990) suggested that closed intramedullary nailing with an interlocking nail is an excellent method of treating closed and |

| |type-I open tibial fractures8. |

| |Tyllianakis M, et al in August 2000 from Department of Orthopaedics, Patras University, Rio, Greece. Retrospectively, studied the results of |

| |non-pilon fractures of distal tibia treated with interlocking intramedullary nailing they reported satisfactory results in 86.3% of cases. |

| |They concluded interlocking intramedullary nailing is a reliable method for treatment of these fractures and is associated with high rates of |

| |union and low incidence of complications.9 |

| |Fan C Y, et al in May 2005 from Department of Orthopaedics and Traumatology, Taipei Vetarens Hospital, National Yang-Ming University, Taiwan |

| |reported that metaphyseal fractures of the distal tibia near the ankle joint are difficult to manage because of poor soft tissue coverage and |

| |comminution of the fracture complicate open reduction. Their prospective study aimed to evaluate practicability of using interlocking nail to |

| |treat such fractures. Using the method of closed reduction and internal fixation with a shortened tibial nail, they enrolled 20 consecutive |

| |cases of distal metaphyseal fractures within 4 cm from the ankle joint from 1997 to 2001. They reported that results were satisfactory and all|

| |fractures united with mean union time of 17.2 weeks and no major complications occurred. They concluded that tibial interlocking nailing is |

| |reliable and safe method of managing metaphyseal fractures of distal tibia near the ankle joint10. |

| |Weber, Timothy.G, et al in their article “The Role of Fibular Fixation in Combined Fractures of the Tibia and Fibula: A Biomechanical |

| |Investigation” suggested that osteotomy of the fibula sighnificantly increased the tibial defect motion when external fixation was used and |

| |plating the fibula in this case significantly decreased motion. Using an Enders rod to stabilize the fibula instead of a plate, with tibial |

| |external fixation, produced smaller decreases in tibial defect site motion. With IM rod fixation of the tibia, osteotomising the fibula had no|

| |effect on defect site motion or on its subsequent stabilization using a plate or IM rod. They hence concluded that Plating the fibula can |

| |decrease motion across a tibial defect, but only when less rigid (i.e.external) fixation is used11. |

| |Kenneth A. Egol, et al in their article “Does Fibular Plating Improve Alignment After Intramedullary Nailing of Distal Metaphyseal Tibia |

| |Fractures?” concluded that the proportion of fractures that lost alignment was smaller among those receiving stabilization of the fibula in |

| |conjunction with IM nailing compared with those receiving IM nailing alone and that adjunctive fibular stabilization was associated |

| |significantly with the ability to maintain fracture reduction beyond 12 weeks. Hence the authors recommended fibular plating whenever IM |

| |nailing is contemplated in the unstable distal tibia fibular fracture12. |

| |Paul M. Morin, et al in their study “Fibular fixation as an adjuvant to tibial intramedullary nailing in the treatment of combined distal |

| |third tibia and fibula fractures: a biomechanical investigation” concluded that fibular plating in addition to tibial IM fixation of distal |

| |third tibia and fibula fractures leads to slightly increased resistance to torsional forces which may not be clinically relevant13. |

| |Prasad M, et al (2013) in their study stated that rotational malalignment and Tibial malalignment (valgus angulation) was less in patients |

| |with lower-third tibia and fibula fractures in whom the fibula was fixed compared to those in whom the fibula was not fixed but the functional|

| |score using Ankle-Evaluation Rating System of Merchant and Dietz after 12 months’ follow-up between the two groups was statistically similar. |

| |There was also no significant difference in the time of union of the tibial fracture between the two groups and no significant difference in |

| |the rate of complications between the two groups14. |

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| |6.3 OBJECTIVES OF STUDY: |

| |To assess and compare the effects of fixation of the fibula in distal 1/3rd tibia-fibula fractures with those in which fixation of the fibula|

| |was not done, the fractured tibia being treated with an interlocking intramedullary tibial nail. |

| |To assess and compare the functional outcomes at the end of 12 months. |

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|7. |MATERIALS AND METHODS |

| |7.1 Source of data : |

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| |All patients admitted under the Department of Orthopaedics at the SDM Hospital, Dharwad who fulfill the criteria mentioned below and are |

| |operated with Interlocking intramedullary nail with or without fixation of fibula. |

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| |7.2 Study type - Prospective Cohort study |

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| |Method of Collection of Data: |

| |The study will be conducted at the Department of Orthopaedics, SDMCMSH, Dharwad. The patients will be selected for the study depending on the |

| |inclusion and exclusion criteria. The complete data is collected from the patients in a specially designed Case Record Form (CRF) which |

| |includes history of illness and detailed clinical examination and relevant investigations. Before subjecting the patients for investigations |

| |and surgical procedures written/informed consent will be obtained from each patient/ legal guardian. |

| |Post operatively all the cases are followed up at regular intervals for a minimum period of 12 months. Results will be analyzed both |

| |clinically & radiologically and functional outcome at the end of one year will be evaluated with the help of Johner and Wruh’s Criteria7. |

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| |Sample Size : |

| |All the patients who satisfy the inclusion and exclusion criteria and are operated in the time period of October 2013 to November 2014 will be|

| |included in the study. Patients will be treated with intramedullary medullary interlocking nail for tibia with or without fixation of fibula |

| |with plates and screws. The decision to fix the fibular fracture will be by randomisation of cases. Two groups of equal numbers will be taken.|

| |The study type will be Prospective Cohort study with a minimum 1 year follow up post-surgery. |

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| |Inclusion Criteria: |

| |Age more than 18 years, both males and females. |

| |2. Patients with fracture of both Tibia and Fibula of the leg involving region between mid 1/3rd-distal 1/3rd junction to 5-6 cm proximal to |

| |the ankle joint. |

| |3. Patient fit for surgery |

| |4. Closed and Gastilo & Anderson type I & II open lower one-third fractures of the leg. |

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| |Exclusion Criteria: |

| |Patients less than 18 years of age |

| |Patients unfit for surgery |

| |Patients with intra-articular fractures of the distal third of the tibia and fibula |

| |Patients not willing for surgery |

| |Gastilo & Anderson type III open lower one third fractures -. |

| |Associated neuro-vascular injuries |

| |Pathological fractures |

| |Segmental fractures of tibia |

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| |7.3 DOES THE STUDY REQUIRE ANY INVESTIGATION OR INTERVENTION TO BE CONDUCTED ON PATIENTS, HUMANS OR ANIMALS? IF SO, PLEASE DESCRIBE BRIEFLY. |

| |Yes, The study requires clinical examination of the patient, appropriate blood and radiological tests. |

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| |7.4 HAS ETHICAL CLEARANCE HAS BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.3? |

| |Yes. Ethical clearance has been obtained for the study. |

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| |7.5 STATISTICAL ANALYSIS : |

| |Results will be analyzed by using appropriate statistical tests. |

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From

Dr. Prashanth Naik

Post Graduate, Department Of Orthopaedics

SDMCMSH, Dharwad.

To,

The Principal

SDMCMSH, Dharwad

(THROUGH PROPER CHANNEL)

Respected, Sir

Sub: Submission of synopsis for registration of subject for dissertation.

I am here with submitting my proforma for registration of dissertation titled “Role of Fibular fixation in Distal Third Tibia-Fibula fracture treated with Intramedullary Interlocking nail”.

Kindly forward this to RGUHS, Bangalore.

Thanking you,

Your’s faithfully,

Dr. Prashanth Naik

Place: Dharwad

Date:

|8. | LIST OF REFERENCES: |

| |Canale & Beaty. Campbell's Operative Orthopaedics,11th edition. Volume-3, Pg. Elsevier;2007. |

| |Richter D, Hahn MP, Laun RA, et al. Ankle para-articular tibial fracture: Is osteosynthesis with the unreamed intramedullary nail |

| |adequate?. Chirurg 1998;69: 563-70. |

| |Strecker W, Suger G, Kinzl L. Local complications of intramedullary nailing]. Orthopade 1996;25:274-91. |

| |Duda GN, Mandruzzato F, Heller M, et al. Mechanical boundary conditions of fracture healing: borderline indications in the |

| |treatment of unreamed tibial nailing. J Biomech 2001;34:639-50. |

| |Whorton AM, Henley MB. The role of fixation of the fibula in open fractures of the tibial shaft with fractures of the ipsilateral |

| |fibula: indications and outcomes. Orthopedics 1998; 21: 1101-5. |

| |Gerhard BG Kuntscher. The Kuntscher method of intramedullary fixation. Journal of Bone & Joint Surgery. 1958;40A:17-26. |

| |Wruhs O, Johner R. Classification of tibial shaft fractures and correlation with results after rigid fixation. Clinical |

| |Orthop.1983;17. |

| |Court Brown CM, Christie J, McQueen MM. Closed intramedullary tibial nailing. Journal of Bone & Joint Surgery. 1990;72B:605-611. |

| |Tyllianakis M; Megas P; Giannikas D; Lambiris. Intramedullary Nailing in distal Tibia Fractures. E Orthopaedics. August |

| |2000;23(8):805-808. |

| |Fan CY, Chiang CC, Chuang TY, Chiu FY, Chen TH. Interlocking nails For Displaced Metaphyseal Fracture Of Distal Tibia. Injury. 2006|

| |July;37(7):676. |

| |Weber, Timothy G.; Harrington, Richard M .; Henley, M . Bradford; Tencer, Allan F. The Role of Fibular Fixation in Combined |

| |Fractures of the Tibia and Fibula: A Biomechanical Investigation. J Orthop Trauma; April 1997;11(3):206-211. |

| |Kenneth A. Egol, Russell Weisz, Rudi Hiebert, Nirmal C. Tejwani, Kenneth J. Koval, Roy W. Sanders. Does Fibular Plating Improve |

| |Alignment After Intramedullary Nailing of Distal Metaphyseal Tibia Fractures. J Orthop Trauma 2006;20:94–103. |

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| |Paul M. Morin, Rudolf Reindl, Edward J. Harvey,Lorne Beckman, Thomas Steffen. Fibular fixation as an adjuvant to tibial |

| |intramedullary nailing in the treatment of combined distal third tibia and fibula fractures: a biomechanical investigation. Can J |

| |Surg. February 2008;51(1):45-50. |

| |Manish Prasad, Sanjay Yadav, Ajaydeep Sud, Naresh C. Arora, Narender Kumar, Shambhu Singh. Assessment of the role of fibular |

| |fixation in distal-third tibia–fibula fractures and its significance in decreasing malrotation and malalignment. Injury. December |

| |2013; 44(12) :1885-1891. |

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|9. |Signature of the candidate | |

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| | |DR. PRASHANTH NAIK |

|10. |Remarks of the guide |Lack of conclusive studies on the outcome of fracture distal third tibia-fibula with fibular |

| | |fixation calls for this study. |

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|11. |Name and Designation |Dr. Chidendra. m. SHETTAR |

| | |pRofessor |

| |11.1 Guide |Department Of Orthopaedics, |

| | |SDM College of Medical Sciences & Hospital, |

| | |Sattur, Dharwad. |

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| |11.2 Signature | |

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| | |DR. RAVI DADDIMANI |

| |11.3 Co- Guide |asst. pRofessor |

| | |Department Of Orthopaedics, |

| | |SDM College of Medical Sciences & Hospital, |

| | |Sattur, Dharwad. |

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| |11.4 Signature | |

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| | |DR. CHANDRAKANT D. NALLULWAR , |

| |11.5 Head of the Department |Professor &. HOD, |

| | |Department Of Orthopaedics, |

| | |SDM College of Medical Sciences & Hospital, |

| | |Sattur, Dharwad. |

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| |11.6 Signature | |

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|12. |12.1 Remarks of the Principal and | |

| |Chairman | |

| |12.2 Signature | |

ANNEXURE – IV

PROFORMA FOR STUDY

NAME :

SEX :

AGE : DATE OF ADMISSION:

IP/OP no : DATE OF DISCHARGE:

History of injury:

Date of injury:

Mechanism of injury: Direct:

Indirect:

Any other associated injury:

Details of primary treatment received:

Past History:

Previous mobility of the patient:

Any coexisting systemic illness:

Details (if any) of the treatment patient is (was) receiving:

Systemic diseases:

Personal History:

Smoking / Alcohol:

General Physical Examination:

Local examination:

Inspection:

Palpation:

Measurement:

Movements:

Investigations:

Blood:

X-ray examination:

CT (if done):

Type of fracture (class):

Closed/ Open (type):

Side:

Treatment:

Surgery:

Date of surgery:

Duration of surgery:

Surgical approach:

Implant used (with exact dimensions and holes):

Placement of implant:

Number and type of screws used:

FOLLOW UP PROFORMA

Assessment at 6 weeks as advised in discharge card:

- Interaction with patient about pain at fracture site/stiffness

-Clinical assessment including ankle function/range of motion.

- Radiological assessment.

Assessment at 12 weeks as advised in discharge card:

- Any complaints may be noted.

- Clinical and radiological assessment.

Assessment at 6 months:

- Any complaints may be noted.

- Clinical and radiological assessment

Assessment at the end of 12 months:

Clinical assessment

Tibial Malalignment

Varus/Valgus (radiologically) :

Procurvatum/Recurvatum (radiologically):

Rotational Malalignment (clinical measurement) :

Functional outcome (using Johner and Wruh’s criteria)

Functional Scoring system to be used at the end 12 months:-

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VOLUNTEER’S CONSENT FORM

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| |

|Principal investigator Guide |

| |

|DR. PRASHANTH NAIK DR. Chidendra. m. SHETTAR |

|Post Graduate Student Professor and Unit Head |

|Dept of Orthopaedics Dept of Orthopaedics |

|SDMCMS&H, Dharwad-09 SDMCMS&H, Dharwad-09 |

| |

| |

|STUDY - Role of Fibular fixation in Distal Third Tibia-Fibula fracture treated with Intramedullary Interlocking nail . |

1. This study has been explained to me and I understand what the study involves.

2. I understand that I can refuse to permit carrying on with the any of the procedure said above.

3. The study involves clinical examination, and Radiologic Examination. The above said examinations are for the study purpose and help my treatment.

I therefore agree to take part in this study.

Signature of the Patient………………………………………………

Full name…………………………………………………………..

Date……………………..

Full address………………………………………………………….

………………………………………………………………………….

I HAVE BEEN PRESENT WHILE THE PROCEDURE HAS BEEN EXPLAINED TO THE PATIENT AND I HAVE WITNESSED HIS/HER CONSENT FOR THE PROCEDURE

Signature of the witness…………………………………………….

(The witness should not be a person connected with the study)

Full name……………………………………………………………

Date…………………..

Full address……………………………………………………………………………..

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