1



RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA

BANGALORE

ANNEXURE – II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

|1 |Name of the candidate and address ( in block |: |Dr. Abhijit A Patil |

| |letters) | |DEPARTMENT OF orthopaedic |

| | | |MAHADEVAPPA RAMPURE MEDICAL COLLEGE, GULBARGA- 585105 |

| |Permanent address |: |MIG 18 Shanti Nagar MSK Mill Road Opp. Bus Stand, Gulbarga – 58103 |

|2 |Name of the institution |: |H.K.E. SOCIETY’S MAHADEVAPPA |

| | | |RAMPURE MEDICAL COLLEGE, |

| | | |GULBARGA – 585105 |

|3 |Course of study and subject |: |M. S. (ORTHOPAEDICS) |

|4 |Date of admission to the course |: |31st May 2010 |

|5 |Title of Topic |: |Treatment of Fracture shaft femur with ender’s nail in children and |

| | | |adolescents |

|6 |Brief Resume of the intended work |

| |6.1 |Need for the study |

| | |Femoral shaft fractures account for 1.6% of all pediatric bony injuries1. There is little controversy over the treatment |

| | |of adult femoral shaft fractures with intramedullary nail fixation. Similarly, there is little controversy over the |

| | |treatment of infants and toddlers with femoral shaft fractures by using spica casting,2 but the treatment of pediatric and|

| | |adolescent (age 6 to 16 years) femur fractures remains controversial. Differences of opinion about treatment are greatest |

| | |for patients who are too old for early spica casting and yet too young for adult type of treatment with a reamed rod. |

| | |Current treatment options include early spica casting, traction, external fixation, ORIF with plating, flexible |

| | |intramedullary nails and reamed |

| | |intramedullaiy rods.3 |

| | | |

| | |In children fractures of the femoral shaft are commonly treated by various types of traction for about 3 weeks, followed |

| | |by plaster cast immobilization. The two major drawbacks with this treatment are prolonged bed rest leading to separation |

| | |of the child from routine activities and the expenditure incurred on the treatment during the stay in the hospital.4 |

| | | |

| | |Time and experience of many clinicians have shown that children with diaphyseal femur fracture do not always recover with |

| | |conservative treatment. Angulation, malrotation and shortening are not always corrected effectively.5 |

| | | |

| | |The management of pediatric femoral shaft fractures gradually has evolved towards a more operative approach in the past |

| | |decade. This is because of a more 2 rapid recovery and reintegration of the patients and a recognition that prolonged |

| | |immobilization can have a negative effect even in children.6 |

| | |Plating of femoral shaft fracture offers rigid fixation, it requires a larger exposure with the potential for increased |

| | |blood loss and scarring. It is a load bearing device and refracture is a risk. Antegrade nailing techniques have shown a |

| | |risk of proximal femoral deformities and avascular necrosis of the femoral head.7,8 |

| | | |

| | |Elastic internal fixation in the form of flexible intra medullary nailing provides a healthy environment for fracture |

| | |healing with some motion leading to increased callus formation.9 |

| | | |

| | |Ender rod fixation in the paediatric population is simple, effective and minimally invasive. It allows stable fixation, |

| | |rapid healing and a prompt return of the child to normal activity. Functional results are excellent and complications are |

| | |minor.7 |

| |6.2 |Review of Literature |

| | |Rush LV (1968), Studied about 211 cases of fracture shaft femur. The objective of the research had been to find a means of|

| | |osteosynthesis which is conductive to bone healing without deformity with minimal risk to life and limb, with minimal |

| | |surgical trauma to bone and soft tissue, yet interfering as little as possible with the normal function of the limb and |

| | |body of the patient. He observed that, femur is a trumpet bone. Any type of rod though tightly impacted at the isthmus, |

| | |might not give firm fixation of the lower fragment. The curved rod driven deeply into the lateral condyle enhances the |

| | |fixation dynamically by 3 point pressure.17 |

| | | |

| | |Gross RH et a! (1983), Conducted a study on 72 patients aged 5-19 years sustaining femoral shaft fractures, were treated |

| | |with immediate cast bracing at Ok lahama Children’s Memorial Hospital. Ambulation was started at an average of 3 days of |

| | |fracture when there was no associated injures. Proximal as well as middle and distal fractures were treated, but varus and|

| | |anterior angulation was not well controlled in proximal fractures. Middle 1 /3 fractures showed more tendency toward |

| | |shortening. All six fractures that healed with more than 1.5cm shortening were middle 113rd they observed that adolescent |

| | |male with a mid shaft fracture was most difficult to manage, and in this situation, closed intramedullary nailing is |

| | |recommended.18 |

| | | |

| | |Fern LH et a! (1989), Reviewed a series of 25 femoral shaft fractures in 23 patients aged 10 to 16 years treated with |

| | |flexible intramedullary nailing. Average hospitalization time was 11.7 days. All fractures healed with no leg length |

| | |inequality. Three patients sustained intraoperative extension of the fracture resulting in healing with angular or rotator|

| | |malalignment. All patients had normal gait and were able to participate in full activities including athletics. They |

| | |concluded this procedure should be considered for the treatment of femoral shaft fractures in this age group.19 |

| | | |

| | |Reeves RB et a! (1990), Performed comparative studies between groups of adolescents with a femur fracture treated |

| | |operatively and treated by conventional traction and casting techniques. The operative group had better results, with a |

| | |shorter hospitalization time and reduced patient costs. Than did the non operative groups.20 |

| | | |

| | |Heinrich SD et a! (1994), Conducted a study on 78 diaphyseal femur fractures stabilized with flexible intramedullary |

| | |nails. According to the study children more than 10 years of age will occasionally have femur fractures that cannot be |

| | |reduced or held in an acceptable alignment by traction and casting. These patients require operative management. Children>|

| | |10 years of age with an isolated femoral shaft fracture have been reported to have better results if treated surgically. |

| | | |

| | |They observed that the results obtained using flexible intramedullary nails for the stabilization of select paediatric |

| | |diaphyseal femur fractures are comparable to non operative methods of treatment, but with less disruption to family life |

| | |and a shorter hospitalization.5 |

| | | |

| | |Canale TS et a! (1995), Observed that open reduction and plate fixation of femoral fractures in the age group of 5 to 10 |

| | |years old children will result in femoral over growth and limb length discrepancy. The second operative procedure required|

| | |for plate removal may further stimulate growth and increase the limb length discrepancy. Also they observed that closed |

| | |antegrade insertion of an intramedullary nail in children less than 10 years old may cause premature growth arrest of the |

| | |greater trochanteric apophysis and thinning of the base of the femoral neck. Apophyseal growth arrest in children less |

| | |than 9 years of age causes valgus deformity of the proximal part of the femur because of the continued growth of the |

| | |proximal femoral physis.23 |

| | | |

| | |Carrey TP and Galpm RD (1996), have reported that flexible nailing seems better suited to paediatric femoral fractures |

| | |because most have a stablepattem. The thick periosteum that envelops the immature femur tends to resist rotational |

| | |displacement and also makes closed reduction and nailing easier to achieve. A retrospective review of the experience with |

| | |antegrade flexible intramedullary nailing in 25 children was performed. No nonunions or significant malunions were seen. |

| | |Follow up evaluation of limb lengths and proximal femoral morphology showed minor variations of articulotrochanteric |

| | |distance and neck shaft angle, none of which were clinically significant. Minor limb length discrepancies were noted. (-11|

| | |to + 14mm). |

| | | |

| | |Bar-on E et al (1997), compared the use of flexible intramedullary nail with external fixation and reported that the time |

| | |to full weight bearing, full range of movement and return to school all were decreased in patients who were treated with |

| | |flexible intramedullary nails. They recommend the use of flexible intramedullary nailing for most peadiatric fractures of |

| | |the femoral shaft which justify surgery. They reserve external fixation for open or severely comminuted fractures.6 |

| | | |

| | |Infante AF et al (2000), reported that hip spica cast treatment in fracture shaft femur in children is very user dependent|

| | |and time consuming for the working and the care giver when both parents are working. For one of the working parent to stay|

| | |home with their child for 6 to 8 weeks ensuring economic loss may cause financial hardship. Staying home with the child |

| | |and missing work was one of the parents main complaints reported in the following questionnaire. They also observed that, |

| | |larger the child more difficult it will be to control the fracture with the hip spica cast and harder it will be to |

| | |transport the patients in the hip spica cast. This has prompted orthopedic surgeons to pursue surgical treatment for |

| | |children with isolated femoral shaft fracture.28 |

| | | |

| | |Lee SS et al (2001), conducted a biomechanical study to determine the effects of flexible intramedullary nail fixation on |

| | |simulated transverse and comminuted midshaft femur fractures using two ender nail. |

| | | |

| | |They observed that length and rotational control of midshaft femur fractures with two divergent ender nails may be |

| | |sufficient for early mobilization.3 |

| | | |

| | |Yamaji T et a! (2002), compared the callus formation after interlocking and ender nailing. They observed that, callus |

| | |appeared at a mean of 2.89 weeks in the ender group and 3.9 weeks in the interlocking group. The mean area of callus |

| | |formation in the ender nailing and interlocking group was 699.4 mm2 and 439.5mm2 respectively. Their results indicated |

| | |that the elasticity of the fixation obtained with ender nailing promotes more callus formation.29 |

| | | |

| | |Ozturkman Y et a! (2002), evaluated the results of using ender nails in femur shaft fracture in children. Union was |

| | |achieved in all patients with a mean of 6.6 weeks. The femur length remained equal to that of the contralateral side in |

| | |76% of the cases. All but one patient had a symmetric walling pattern.30 |

| | | |

| | |Aksoy C et a! (2003), compared the results of compression plate fixation and flexible intramedullary nailing in 36 femoral|

| | |shaft fractures in children. They observed that intramedullary nailing maintains shorter operation time and shorter time |

| | |and shorter time to healing. The lack of need of post-operative immobilization and small incision for the insertion of the|

| | |nail which is cosmetically more acceptable are the other advantages of this method.31 |

| | | |

| | |Khurram BARLAS & Hummayun BEG (2006), recommended the use of flexible intramedullary nailing for most pediatric fractures |

| | |of the femoral shaft between 5-15 years age which require surgery, as it is a safe procedure and produces reliable |

| | |results.32 |

| | | |

| | |M. Khazzam et a! (2009), demonstrated that use of flexible intra-medullary nails in the treatment of femoral shaft |

| | |fractures in children is successful regardless of patient age, fracture location, or fracture pattern.33 |

| |6.3 |Objectives of the study |

| | |To study the functional outcome following the use of Enders nail for femoral shaft fractures in children and adolescents. |

| | |To study the duration of union in the above mentioned fractures. |

| | |To study the complications of flexible intramedullary nailing of femoral shaft fracture. |

|7 |Materials and methods |

| |7.1 |Source of data |

| | |The patients admitted to the Department of Orthopaedics at M. R. Medical College, Gulbarga and Basaveshwar Teaching and |

| | |General Hospital, Gulbarga with Shaft femur fracture (children & adolescent) satisfying inclusion criteria. |

| |7.2 |Methods of collection of data ( including sampling procedure, if any) |

| | |In this study 25 patients, aged 5 to 18 years, with fracture shaft of the femur will be treated with retrograde flexible |

| | |intramedullary (Ender) nailing at Basaveshwar Teaching & General Hospital, attached to M. R. M. C. Medical College |

| | |Gulbarga. During the study period of December 2010 to September 2012. According to hospital statistics an average number |

| | |of 20 fracture shaft femur (in children adolescent) Cases every year, satisfying inclusion criteria were admitted in |

| | |previous two years. Hence I intend to study 20 —25 cases. |

| | | |

| | |Inclusion criteria: |

| | |Children and adolescent patients between 5 to 18 years of age |

| | |Simple femoral shaft fracture |

| | |Type I and II compound fracture |

| | | |

| | |Exclusion criteria: |

| | |Patients less than 5 years of age and more than 18 years of age |

| | |Patients medically unfit for surgery |

| | |Comminuted and segmental fracture |

| | |Type III compound fracture |

| | |Very distal (or) very proximal fracture that precludes nail insertion. |

| | |Does the study require any investigation or intervention to be conducted on patients or other humans or animals? if so |

| |7.3 |please describe briefly |

| | | |

| | |YES, In our study the following investigations are conducted each patients. All the patients included in the study will be|

| | |investigated thoroughly with |

| | | |

| | |Routine Blood Investigations (Complete Blood Count, bleeding time, clotting time Random Blood Sugar, Serum Urea, Serum |

| | |Creatinine) |

| | |Urine routine (Albumin, Sugar, Microscopy) |

| | |ECG and 2D Echo where ever required. |

| | |Radiological examination pre operatively and post operatively X-ray will be taken. |

| | |Anteroposterior (AP) view of pelvis. |

| | |Internal rotation view of the affected hip. |

| | |Femur, full length, AP and lateral views. |

| | |Cross table lateral and AP views of the affected hip. |

| | | |

| | |Before subjecting the patients for investigations and surgical procedures, written/informed consent will be obtained from |

| | |each patient / legal guardian. All the investigations and surgical procedures will be undertaken the direct guidance an |

| | |supervision of our guide. |

| | | |

| | |Radiological examination will be repeated post-operatively and at the end of 6 weeks, 12 weeks and 6 months intervals. |

| | | |

| | |Patients will be followed up at 6 weeks, 12 weeks, and at 6 month. |

| | | |

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

| | | |

| | |YES, Ethical clearance has been obtained from, the institution. There is a committee consisting of head of department, |

| | |post graduate professors in orthopedics department. The committee is chaired by the dean. |

| 8 |List of References |

| | |

| |Scherl SA, Miller L, Lively N, Russinof S, Sulivan M Tornetta P III. EtaL “Accidental and nonaccidental femur fractures in children”.|

| |Clin Orthopand Rel Research 2000;376:96-105. |

| |Momberer N., Stevens P., Smith J., Santora 5, Scott S and AndersonJ. “Intramedullary nailing of femoral fractures in adolescents”. J |

| |Pediatrorthop 2000; Vol. 20:482-484. |

| |Lee SS, Mahar AT and Newton P0. “Ender nail fixation of pediatric femur fractures. A biomechanical analysis”. J Pediatrorthop 2001; |

| |Vol. 2 1:442-445. |

| |Ligier IN, Metaizeau JP., Prevot J. and lascombes P. “Elastic stableintramedullary nailing of femur shaft fractures in children”. J |

| |bone & joint surg (Br) 1988; Vol. 70B: 74-7. |

| |Heinrich SD., Drvaric DM., Karr K. and Macevan GD. “The operativestabilization of pediatric diaphyseal femur fractures with |

| |flexibleintramedullary nails: A prospective analysis”. J Pediatrorthop 1994; Vol. 14: 501-507. |

| |Carey TP. And Galpin RD. “Flexible intramedullary nail fixation of femoral fractures”. Clin Orthop and Rel Research 1996; 332: |

| |110-118. |

| |Cramer KE., Tometta P. III, Spero CR, after S. Miraliakbar H, Teefey J. “Ender rod fixation of femoral shaft fracture in children”. |

| |Clin orthop and Rel Research 2000; 376: 119-123. |

| |Townsend DR and Hoffinger S. “Intramedullary nailing of femoral shaft fractures in children via the trochanteric tip”. Clin orthop |

| |and Rel Research 2000; 376: 113-118. |

| |Kasser JR. and Beaty JH. “Femoral shaft fractures”. In: Beaty JH. And Kasser JR eds. Rockwood and wilkin’s fracture in children, 5th |

| |edition, Philadelphia, Lippincott, Williams and wilkins, 2001; 94l-98Opp. |

| |Gallant A. “Van Arsdale’s triangular splint in 33 cases of fractures of the femur in infants and children under 6 years of age”. JAMA|

| |1897; 25: 1239- 1249. |

| |Desault P. I. “A treaties on fractures, dislocations and other affections of the bones, Philadelphia, Kimber and Conard: 181 ‘pp. |

| |Starr L. “An American textbook of the diseases of children, Philadelphia, W. B. Sanders, 1894. |

| |Firror W. “The use of plates in the treatment of fractures of femur”. Bull. Hohns Hopkins Hospital 1924; 35: 412-415. |

| |Keating J. “Cyclopedia of the disease of children”. Philadelphia, J. B. Lippihcott, 1890. |

| |Speed K. ‘Analysis of the results of treatment fractures of femoral diaphysis in children under 12 years of age “. Surg Gynaec obsted|

| |1921;32: 527-534. |

| |McCatney D. Hinton A. and heinrich SD. “Operative stabilization of pediatric femur fractures”. Orthop din north Am 1994; Vol. 25 (4):|

| |635-650. |

| |Rush LV. “Dynamic intramedullary fracture fixation of the femur reflections on the use of the round rod after 30 years”. Clin orthop |

| |and Rd Research 1986; 60: 21-27. |

| |Gross RH., Davidson R., Sullivan JA., Peeples RE. and Hufft R. “Castbrace management of the femoral shaft fracture in children and |

| |youngadults”. J pediatr orthop 1983; 3 (5): 572-582. |

| |Fein LH., Pankovich AM., Spero CM. and Brauch HM. “Closed flexible intramedullary nailing of adolescent femoral shaft fractures”. J |

| |orthop trauma 1989; 3 (2): 133-41. |

| |Reeves RB., Ballard RI and Hughes JL. “Internal fixation versus tractionand casting of adolescent femoral shaft fractures”. J Pediatr|

| |orthop 1991; 10 (5): 592-595. |

| |Galpin RD., Willis RB. And Sabano N. “Intramedullary nailing of pediatric femoral fractures”. J Pediatrorthop 1994; 14: 184-189. |

| |Karaoglu S. et al. “Closed ender nailing of adolescent femoral shaft fractures”. Injury 1994; 25 (8): 501-506. |

| |Canale TS and Tolo VT. “Fractures of the femur in children”. J Bone & Joint Surg 1995; 77-A (2): 294-3 15. |

| |Mileski RA., Garvin KL, Huurman WW. “Avascular necrosis of the femoral head after closed intra medullary nailing in an adolescent”. J|

| |Pediatrorthop 1995; 15: 24-6. |

| |Gregory P., Sullivan JA. And Herndon WA. “Adolescent femoral shaft fractures: rigid versus flexible nails”. Orthopedics 1995; 18 (7):|

| |645-649. |

| |Skak SV., Overgaard S, Nielson JD, Anderson A and Nielson S. T. “Inernal fixation of femoral shaft fractures in children and |

| |adolescents: a ten to twenty one years follow up of 52 fractures”. J Pediatr orthop 1996; 5 (3):195-9. |

| |Bar-on E, Sagiv S. and Porat S. “External fixation or flexible intramedullary nailing for femoral shaft fractures in children”. J |

| |Bone and Joint Surg (Br) 1997; 79-B: 975-8. |

| |Infant AF. Jr. Albert MC, Jenning WB. And Lehner JJ. “Immediate hipspica casting for femur fracture in pediatric patients — A review |

| |of 175 patients”. Clin orthop and Rel Research 2000; 376: 106-1 12. |

| |Yamaji T., Ando K., Nakamura T., wahimi 0., Terada N. and Yamada H. “Femoral shaft fracture callus formation after intramedullary |

| |nailing: a comparison of interlocking and ender nailing”. J Orthop Science 2002; 7 (4): 472-6. |

| |Ozturkman Y. Dogrul C, Balioglu MB. and Karli M. “Intramedullarystabilization of pediatric diaphyseal femur fracture with elastic |

| |ender nails”.Acta Orthop Traumatol Jure 2002; 36 (3): 220- 7. |

| |Aksoy C, Caolar 0., Yazyoy M and Surat A. ?pediatric femoral fractures: A comparison of compression plate fixation and flexible |

| |intramedullary nailfixation”. J Bone & Joint Surg (Br) 2003; 85-B: Supp III: 263pp. |

| |Khurram BARLAS, Humayun BEG. “Flexible intramedullary nailing versus external fixation of paediatric femoral fractures”.Acta Orthop. |

| |Beig., 2006, 72, 159-163. |

| |Michael Khazzam, MD, Channing Tassone, MD, Xue C. Liu, PhD, MD, Roger Lyon, MD, Brian Freeto, MD, Jeffery Schwab, MD, and John |

| |Thometz, MD. “Use of Flexible Intramedullary Nail Fixation in Treating Femur Fractures in Children”. Am J Orthop. 2009;38(3):E49-E55.|

| | | |

|9 |Signature of Candidate | |

| | | |

|10 |Remarks of guide |Satisfactory |

| | | |

| | | |

| | | |

| | | |Dr. B.C. Patil |

|11 |11.1 |Name and designation of the Guide |M.S. (Ortho) D (Ortho) |

| | | |Professor and Head |

| | | |Department of orthopaedics |

| | | |M.R. Medical College, Gulbarga |

| | | | |

| |11.2 |Signature | |

| | | | |

| |11.3 |Co- guide (if any) | |

| | | | |

| |11.4 |Signature | |

| | | |Dr. B.C. Patil |

| |11.5 |Head of the Department |M.S. (Ortho) D (Ortho) |

| | | |Professor and Head |

| | | |Department of orthopaedics |

| | | |M.R. Medical College, Gulbarga |

| | | | |

| |11.6 |Signature | |

| | | | |

| | | | |

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

| | | | |

| |12.2 |Signature | |

| | | | |

| | | | |

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