RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA.
ANNEXURE – II
SYNOPSIS FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1 / Name of the candidate and Address( In Block letters ) /
DR. PRAVEEN KUMAR REDDY. P
POST GRADUATE STUDENT INM.S. ORTHOPAEDICS,
NAVODAYA MEDICAL COLLEGE, RAICHUR – 584104.
2 / Name of the Institution / NAVODAYA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER,
MANTRALAYAM ROAD,
RAICHUR – 584103
3 / Course of study and subject / M.S. ORTHOPAEDICS
( 2 YEARS )
( 2 Years)
4 / Date of admission to the course / 15TH APRIL, 2011
5 / Title of Topic:
ROLE OF INTRAMEDULLARY TITANIUM ELASTIC NAILS IN THE PAEDIATRIC FEMORAL DIAPHYSEAL FRACTURES.
6 / Brief resume of the intended work:
6.1 Need for the Study:
Elastic stable intramedullary nailing (ESIN) for the treatment of paediatric long bone fractures was introduced by Pr´evot and colleagues in 1979. Stabilization follows the three-point fixation principle that provides internal elastic support in the presence of cortical contact and an intact soft-tissue envelope. The technique offers several advantages, including better reduction, dynamic axial stabilization, shorter hospitalization with early rehabilitation and low rate of complications.
In children who are five years of age or younger, early closed reduction and application of a spica cast is an ideal treatment for most diaphyseal femoral fractures. In skeletally mature adolescents, use of antegrade solid intramedullary nail has become standard treatment.
But, the best treatment for children between five to fourteen years of age is still debated. Compared with younger children, patients in this intermediate age group have high risk of shortening and malunion when conservative measures used.
Children managed with traction and spica cast as a treatment modality have to undergo various adverse physical, social, psychological and financial consequences of prolonged immobilization. Various other modalities include external fixation, plates and screws, use of solid antegrade intramedullary nail. However, the risk of certain complications, particularly pintract infection and refractures after external fixation or osteonecrosis with solid antegrade intramedullary nail, has prevented these methods from becoming widely utilized.
Elastic stable intramedullary nailing fixation system is a simple, effective and
minimally invasive technique. It gives stable fixation with rapid healing and prompt return of child to normal activity with out any limb length discrepancy .
This study is intended to assess the results following treatment of fracture shaft of femur by titanium elastic intramedullary nail.
6.2 Review of Literature :
Although femoral diaphyseal fractures are dramatic and disabling injuries, both to the patient and the family, most unite rapidly without significant complications. Not many years ago traction and casting were standard treatment for all femoral shaft fracture in children.
RUSH LV (1968) studied about 211 cases of fracture shaft of femur in children. The objective of the study had been to find an ideal method of treatment with good healing and minimal surgical trauma, to bone and soft tissue. He found out that any type of rod which is tightly impacted at the isthumus, might not give firm fixation of the lower fragment. Only curved rod driven deeply into the lateral condyles enhances fixation dynamically by 3 point pressure1.
GROSS RH et al (1983) conducted a study on 72 patients aged 5-19 years who sustained femoral shaft fractures, were treated with immediate cast bracing at Oklahoma children’s hospital. They observed that in adolescent children femoral shaft fractures were difficult to manage conservatively, which ideally required closed intramedullary nailing2 .
CANALE TS et al (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 overgrowth and limb length discrepancy. Also they observed that antegrade intramedullary insertion of a nail may cause growth arrest of trochanteric epiphysis and thinning of the bone of femoral neck, leading to coxavalga deformity3.
MILESKI et al (1995) observed that flexible IM nails hold many advantages over the reamed nails because the base of femoral neck and retinacular vessels were avoided during insertion of flexible nails4.
GREGORY P et al (1995) compared the use of ender's nail with rigid antegrade nailing and found that both techniques produced satisfactory outcomes but flexible nails required much less operative and fluoroscopy time with similar patient satisfaction and outcomes5.
SKAV SU et al (1996) compared the rigid IM nailing and flexible IM nailing in 52 femoral shaft fractures and found that limb length discrepancies and valgus deformity of hip is more in rigid IM nailing6.
BAR-ON et al (1997) compared the use of flexible IM nail with external fixator and reported that full weight bearing, full range of movement and early return to school all were quick in patients who received flexible IM nails7.
INFANTE AF et al (2000) reported that spica cast treatment in children is user dependant and time consuming for the physician and causes economic loss for parents and financial hardship8.
JOHN FLYNN et al in (2001) and GREISBERG J et al (2002) compared the patients treated with hip spica cast and flexible nails. They concluded that patients treated with flexible nails had early ambulation, shorter hospital stay and early return to school9-10.
YAMAJI T et al (2002) compared the callus formation after interlocking and flexible nailing. Callus appeared at a mean of 2-8 weeks in flexible nail and 3-9 weeks in interlocking group. The mean area of callus formation in the ender nailing and inter locking group was 699.4mm2 and 439.5mm2 respectively. This is because the elasticity of flexible nails promotes more callus formation11.
Intramedullary fixation with elastic nails that are placed percutaneously without violating the physis has become a popular technique for the treatment of paediatric femoral fractures12-13. Two flexible intramedullary nails, introduced in an antegrade or retrograde fashion, cross the fracture site and act as internal splints to maintain length and alignment while allowing sufficient fracture motion to generate callus formation.
These techniques commonly referred to as elastic stable intramedullary nailing or flexible intramedullary nailing has been used successfully the treatment of pediatric fractures of the tibia, femur, humerus, and forearm.
6.3 Objectives of study :
· To determine the demographic (age and sex) distribution of paediatric diaphyseal fractures of femur and tibia.
· To study the advantages of TENS.
· To study the union rates and functional outcome of closed reduction and internal fixation of paediatric widely displaced diaphyseal fractures of femur and tibia with TENS.
· To compare the results with those in literature.
7. / MATERIALS AND METHODS:
7.1 Source of data :
Children (minimum of 30) admitted to the Department of Orthopaedics at Navodaya Medical College, Raichur with diaphyseal fractures of femur from NOVEMBER 2011 to OCTOBER 2012 will be selected. All the children who will be operated during this period are included in the study. Those children between age 5 to 14 years and managed surgically will be included in the study.
7.2 Method of Collection of Data:
( Including the sampling procedure if any )
The complete data will be collected from the children in a specially designed Case Record Form (CRF) by taking history of illness and by doing detailed clinical examination and relevant investigations.
Finally after the diagnosis, the children will be selected for the study depending on the inclusion and exclusion criteria. Post operatively all the cases will be followed until fracture unites, for the minimum period of 6 months to 12 months. Results will be analysed both clinically & radiologically.
Study Design : Prospective Study
Study Period : 12 Months
Inclusion Criteria:
a) Children and adolescent patients from 5 to 14 years with
diaphyseal femur fracture.
b) Children of both the sexes.
c) Children with closed diaphyseal fractures of femur.
d) Patients fit for surgery.
Exclusion Criteria:
a) Patients less than 5 years of age and more than 14 years of age.
b) Patients unfit for surgery.
c) Comminuted and segmental fractures.
d) Patients not willing for surgery.
e) Open fractures.
f) Fractures involving the distal 1/3rds of femoral shaft.
Evaluation: The results will be evaluated with TENS SCORING SYSTEM used by FLYNN et al as shown in table 1.
Table 1 :
The Scoring Criteria for Tens
Excellent Successful Poor
Limb length
Discrepancy < 1cm < 2cm > 2cm
Sequence
Disorder 5° 10° 10°
Pain Absent Absent Present
Complication Absent Mild Major
7.3 Does the study requires any investigations or interventions to be conducted on patients or other humans or animals? If so please describe briefly.
YES, in our study the following investigations will be conducted in each patient. All the patients included in the study will be investigated thoroughly with
1. Routine blood investigations ( Complete Blood Count, Random
Blood Sugar, bleeding time, clotting time, blood urea, Serum Creatinine )
2. Urine routine ( Albumin, Sugar, Microscopy )
3. Radiological examination will be done pre operatively, x rays of femur full length
- AP view
- Lateral view
Radiological examination will be repeated post-operatively and at the end of 3weeks, 6 weeks, 12 weeks and 6 months intervals.
Patients will be followed up at 3weeks, 6 weeks, 12 weeks and at 6 months interval.
7.4 Has ethical clearance been obtained from your Institution in case of 7.3 ?
YES
8. / List of References.
1. Rush LV. 1968 ‘Dynamic intramedullary fracture fixation of the femur
Reflections on the use of the round rod after 30 years’. Clin Orthop and
Rel Research; 60: 21-27.
2. Gross RH., Davidson R., Sullivan JA., Peeples RE. and Hufft R. 1983 ‘Cast
brace management of the femoral shaft fracture in children and young
adults’. J Pediatr Orthop; 3 (5) : 572-582.
3. Canale TS and Tolo VT. 1995 ‘fractures of the femur in children’. J Bone &
Joint Surg; 77-A (2) : 294-315.
4. Mileski RA., Garvin KL., Huurman WW. 1995 ‘Avascular necrosis of the
femoral head after closed intra medullary nailing in an adolescent’. J
Pediatr Orthop; 15: 24-6.
5. Gregory P., Sullivan JA. and Herndon WA. 1995 ‘Adolescent femoral shaft
fractures: rigid versus flexible nails’. J Orthopedics; 18(7) : 645-
649.
6. Skav SU., Overgaard S, Nielson JD, Anderson A and Nielson S.T. 1996
Internal fixation of femoral shaft fractures in children and adolescents: a
ten to twenty one year follow up of 52 fractures’. J Pediatr Orthop;
5(3): 195-9.
7. Bar-on E, Sagiv S. and Porat S. 1997 ‘External fixation or flexible
intramedullary nailing for femoral shaft fractures in children’. J Bone
Joint Surg (Br); 79-B: 975-8.
8. Infante AF. Jr. Albert MC., Jennings WB. and Lehner JJ. 2000 ‘Immediate
hip spica casting for femur fracture in pediatric patients - A review of
175 patients’. Clin Orthop and Rel Research; 376: 106-112.
9. Flynn JM, Hresko T, Reynolds RA, Blasier RD, Davidson R, Kasser J.
2001 Titanium elastic nails for pediatric femur fractures: a multicenter study
of early results with analysis of complications. J Pediatr Orthop; 21:4-8.
10. Greisberg J, Bliss MJ, Eberson CP, Solga P and d’Amato C. 2002 ‘Social
and economic benefits of flexible intramedullary nails in the treatment
of pediatric femoral shaft fractures’. J Orthopedics; 25(10): 1067-
70.
11. Yamaji T, Ando K., Nakamura T., Washimi O., Terada N. and Yamada
H. 2002 ‘Femoral shaft fracture callus formation after intramedullary nailing
a comparison of interlocking and ender nailing’. J Orthop Science;
7(4): 472-6.
12. Till H, Huttl B, Knorr P, Dietz HG. 2000 Elastic stable intramedullary
nailing (ESIN) provides good long-term results in pediatric long-bone
fractures. Eur J Pediatr Surg; 10:319-22.
13. Ligier JN, Metaizeau JP, Prevot J, Lascombes P. 1988 Elastic stable
intramedullary nailing of femoral shaft fractures in children. J Bone
Joint Surg (Br); 70:74-7.
9 / Signature of the candidate :
10 / Remarks of the guide : / This study is recommended and forwarded.
11 / Name and Designation of :
( In Block Letters)
11.1 Guide: / DR.SOMASHEKARAPPA.T
PROFESSOR
DEPARTMENT OF ORTHOPAEDICS
RAICHUR.
11.2 Signature
11.3 Co – Guide, if any
11.4 Signature
11.5 Head of the Department / DR. R. N. KARIGOUDAR
PROFESSOR AND HEAD OF THE DEPARTMENT,
DEPARTMENT OF ORTHOPAEDICS RAICHUR.
11.6 Signature
12.1 Remarks of Chairman and Principal
12.2 Signature