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 letters) / : / Dr. Abhijit A Patil
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
1.  To study the functional outcome following the use of Enders nail for femoral shaft fractures in children and adolescents.
2.  To study the duration of union in the above mentioned fractures.
3.  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.
7.3 / Does the study require any investigation or intervention to be conducted on patients or other humans or animals? if so 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
1.  Routine Blood Investigations (Complete Blood Count, bleeding time, clotting time Random Blood Sugar, Serum Urea, Serum Creatinine)
2.  Urine routine (Albumin, Sugar, Microscopy)
3.  ECG and 2D Echo where ever required.
4.  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
1.  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.
2.  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.
3.  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.
4.  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.