RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA, BANGALORE.
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1 / Name of the candidate andaddress / DR.VIVEK JHA
S/O- Mr. S. D. JHA
405 , RAMESHWARAM COMPLEX ,
SOUTH OFFICE PARA, DORANDA,
RANCHI , JHARKHAND-834002
2 / Name of the Institution / KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTER, BANGALORE
3 / Course of the study and subject / M.S IN ORTHOPAEDICS.
4 / Date of admission to the course / 31.05.2012
5 / Title of the topic / “EVALUATION OF CLINICAL AND RADIOLOGICAL OUTCOME OF INTERTROCHANTERIC FRACTURES OF FEMUR TREATED WITH PROXIMAL FEMORAL NAIL, A PROSPECTIVE STUDY.”
6
7
8 / BRIEF RESUME OF INTENDED WORK
6.1. Need for study
The incidence of intertrochanteric femoral fracture has been estimated to be more than 250,000 patients each year in the United States, with the reported mortality ranging from 15 to 20%.1,2 The incidence is rising because of increasing number of senior citizens with osteoporosis. The incidence is estimated to be double by 2040.The figures may be much more in India. Most intertrochanteric fractures occur in patients above 50 yrs who have additional systemic problems and functional disability. So the goal to treatment is early mobilization and return to pre operative functional state. Current treatment approach is possible anatomical reduction and rigid fixation.
Several implants evolved for fixation as our understanding of the biomechanics of these fractures improved. There are two main types of implants available for the treatment of these fractures, namely extramedullary and intramedullary implants.
The most widely used extramedullary implant is the dynamic hip screw, which consists of a sliding neck screw connected to a plate in the lateral femoral cortex. Dynamic hip screw (DHS) has been the standard means of fixation of intertrochanteric fractures of femur in the last few decades, because fracture union predictably occurs. A problem with sliding hip screw is collapse of the femoral neck, leading to loss of hip offset and shortening of the leg. Although some such sliding is expected, too much shortening is detrimental to hip function. Failure rates in unstable fractures that may reach up to 23%.3,4
Intramedullary devices offer certain distinct advantages:
- More efficient load transfer than a dynamic hip screw, because of its location.
- A shorter lever arm decrease tensile strain on the implant, thus decreasing the risk of implant failure.
- The intramedullary location limits the amount of sliding and therefore limb shortening and the deformity is also less.
- Requires shorter operative time and less soft tissue dissection than a dynamic hip screw, so decreasing the overall morbidity.
The proximal femoral nail, a recent AO-ASIF intramedullary device, has two screws. The advantages of two screws are:
- More stable fixation.
- Prevention of rotation of proximal fragment.
It also has a Specially shaped tip together with a smaller distal shaft diameter resulting in less stress concentration at the tip.
This study is an attempt to evaluate the effectiveness and safety of the proximal femoral nailing in intertrochanteric fractures of femur in our set up.
6.2 Review of Literature
Simmermacher RK et al5 reviewed 191 patients having proximal femoral fractures treated with proximal femoral nail in one year. After a follow up period of 4 months technical failures were seen in just 4.6% of the cases. They concluded that the result of this new implant compare favourably to the currently available implants for the treatment of the unstable pertrochanteric femoral fractures.
Christian Boldin, Franz J Seibert et al6 in 2000 carried a prospective study of 55 patients having proximal femoral fractures treated with the proximal femoral nail. They achieved good results in most of the patients with very less complications at 12 months follow-up. They concluded that proximal femoral nail is a good minimal invasive implant for unstable proximal femoral fractures.
Pajarinen J et al7 performed a randomized clinical trial comparing the dynamic hip screw and proximal femoral nail in patients with pertrochanteric fractures emphasizing functional outcomes and rehabilitation. At four months review, patients treated with proximal femoral nail regained their preinjury walking ability. Shortening of both the femoral neck and shaft was seen in patients treated with dynamic hip screw, this difference was statistically significant.
Klinger HM et al8 have done a comparative study of 173 unstable intertrochanteric femoral fractures treated with dynamic hip screw and trochanteric buttress plate versus proximal femoral nail. In case of proximal femoral nail 17.2% revisions were necessary and in the case of dynamic hip screw with TBPP 21.6%. A shorter operation time and a considerable shorter in patient stay were common with proximal femoral nail. They concluded that dynamic hip screw with TBPP had a higher incidence of complications in unstable trochanteric fractures than proximal femoral nail.
Reska M et al9 reviewed 83 patients with proximal femoral fractures treated with proximal femoral nail. In their study except for 2 cases postoperative course was favourable in rest of the patients. They concluded a careful surgical approach and technique with a stable osteosynthesis have markedly contributed to a more rapid mobilization of a patient with the use of proximal femoral nail.
Pavelka T et al10 reviewed 79 patients with ipsilateral fractures of the hip and femoral shaft treated with a long proximal femoral nail. In follow up for at least 12 months bone union was achieved in all patients. The outcomes were excellent in 64%, good in 28% and satisfactory in 8%. They concluded that the long proximal femoral nail is a high quality implant that increases the option of treatment of all the reconstruction nails.
Gadegone WM and Salphale YS11 in 2006 carried out a study on 100 consecutive patients who had suffered in intertrochanteric or high subtrochanteric fractures treated with proximal femoral nail. Complications occurred in 12 patients. They concluded that osteosynthesis with the proximal femoral and offers the advantage of high rotational stability of the head-neck fragment.
Kulkarni GS et al12 reviewed the current concepts of treatment of intertrochanteric fractures. They concluded that unstable intertrochanteric fractures can be helped by medullary fixation as there is more failure of dynamic hip screw. Proximal femoral nail developed by the AO has two sliding screws. Advantages of these screws are
1.More stable fixation
2. Prevention of rotational deformity.
Ozkan K, Eceui E et al13 confirmed that mean duration of surgery of Proximal femoral nail in trochanteric fractures is 48 minutes and consolidation time was 8.6 weeks. No intraoperative complications or post operative technical failures and no stress shielding as evidenced by the lack of cortical failures at the level of tip of the implant.
Anjum MP and Husssain N14 concluded that the operating time was found to be short, less blood loss, relatively free from long term complications in Proximal femoral nail. It is a suitable implant for unstable intertrochanteric femoral fractures.
Morihara.T, Arai.Y et al15 stated that free sliding of a Proximal femoral nail may provide better impaction for unstable A2 fractures. The presence of an additional antirotational screw & free sliding mechanism of the lag screw may increase rotational stability of cervicocephalic fragments and decrease overload on femoral head. Thus Proximal femoral nail is useful in all types of trochanteric fractures.
N K Karn et al16 compared the efficacy of PFN and sliding hip screw in the management of trochanteric fractures of femur in 60 patients with 30 in each group in 2007. This study has shown that PFN though costly is superior to sliding hip screw in terms of blood loss, incision length, function of the hip and less complications but equal union rate.
R.N.Singh et al17 conducted a comparative study of PFN and DHS in treatment of intertrochanteric fracture femur in 50 patients with 25 in each group from August 2007 to July 2010 concluded that DHS was tolerated by young patients with stable fracture while PFN had a better outcome with osteoporotic patients and weak bone mass and reverse oblique fractures
Gursimrat Singh Cheema et al18 conducted a biomechanical study in sixteen freshly harvested cadaver compared the cut out resistance of DCS and PFN with 8 in each group concluded that the PFN is biomechanically superior to DCS for the fixation of reverse oblique trochanteric fracture of femur.
Fogagnolo et al19 in 2004 another study concluded that PFN is a suitable implant for unstable fractures, but the high reoperation rate precludes its routine use for every pertrochanteric fracture.
6.3 OBJECTIVES OF THE STUDY
1. To study the management of intertrochanteric fractures of femur with proximal femoral nail.
2. To study the operative difficulties encountered during the procedure.
3. To study the radiological and functional (clinical) outcome of fractures treated with this procedure.
MATERIALS AND METHODS
7.1 SOURCE OF DATA
All cases with the diagnosis of intertrochanteric fracture of femur and meeting the inclusion and exclusion criteria (mentioned below) admitted to the orthopaedics department of KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTER, BANGALORE, during the study period, will be subject of the study.
7.2 a) METHOD OF COLLECTION OF DATA
· By inter osive sampling.antero-posterior view and lateral view of the affected hip.
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXview
· By follow up at 6 weeks, 12 weeks, 24 weeks.
· By clinical examination.
· By analysing case papers.
INCLUSION CRITERIA
· Age group: equal to or more than 18 years.
· Acute post-traumatic inter-trochanteric fracture of femur.
EXCLUSION CRITERIA
· Age: less than 18 years.
· Compound fractures.
· With other fractures in upper and lower limbs which will hamper mobilization of the patient after surgery.
· Peri-prosthetic fractures.
· Patients unfit for surgery.
· Patients unwilling to consent for surgery.
Inpatients meeting the inclusion and exclusion criteria are selected for the study after obtaining written and informed consent. Demographic data, History, Clinical examination and details of investigations will be recorded in the study proforma. Routine pre operative investigations will be done and radiographs to study the fracture anatomy will be taken. Written informed consent and pre anaesthetic evaluation is done for the surgery. Under anaesthesia, closed reduction and internal fixation with proximal femoral nail will be done using image intensifier. Post operatively, the patient will be made to sit on 2nd post op day, and active quadriceps drill started, partial weight bearing started as the wound reaction and patient acceptance improves around one week. Full weight bearing at 6th week depending on the radiological evidence of union of the fracture and acceptance of the patient. Assessment at regular intervals made at 6th, 12th, 24th post op week. At each follow up visit, patient will be evaluated clinically and radiological evaluation of the fracture will be done. All patients will be assessed by using the Kyle’s criteria20 at the follow-ups. Data collected at the end of study will be compared and analyzed with the similar studies done before.
7.2 b) Sample Size And Duration of study
· Sample size: minimum of 30 cases.
· Duration of study: NOVEMBER 2012 to APRIL 2014.
· Study design: case series.
· Sampling method: purposive sampling.
7.3 DOES THE STUDY REQUIRE ANY INVESTIGATIONS OR
INTERVENTIONS TO BE CONDUCTED ON PATIENTS OR OTHER
HUMANS OR ANIMALS?
Yes, the study requires routine pre-operative investigations.
X ray pelvis with both hips- antero-posterior view and lateral view of the affected hip.
No unnecessary investigations will be done in the study.
7.4 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR
INSTITUTION?
Yes, Ethical Clearance has been obtained from the Institutional Ethical Committee of kempegowda institute of medical sciences and research center.
LIST OF REFERENCES:
1.Cummings SR, Rubin SM, Black D. The future of hip fractures in the United States.Numbers, costs, and potential effects of postmenopausal estrogen. Clin Orthop. 1990;252:163–6.[PubMed: 2302881]
2.Cummings SR, Kelsey JL, Nevitt MC, O’Dowd KJ. Epidemiology of osteoporosis and osteoporotic fractures. Epidemiol Rev. 1985;7:178–208.[PubMed: 3902494]
3. Gundle R, Gargan M.F, Simpson HRW (1995) how to minimize failure of fixation of unstable intertrochanteric fractures. Injury 26:611-614.
4. Simpson AHRW, Varty K, Dodd CAF (1989) Sliding hip screws: modes of failure. Injury 20:227–231.
5. Simmermacher RKJ, Bosch AM, Van der Werken C. The AO/ASIF – Proximal femoral nail: A new device for the treatment of unstable proximal femoral fractures. Injury 1999; 30: 327-32.
6. Christian Boldin, Franz J. Seibert, Florian Fankhauser, Gerolf Pericha, Wolfgang Grechenig et al. Proximal femoral nail (PFN) – A minimal invasive treatment of unstable roximal femoral fracture. Acta Orthopaedica 2003 Feb; 74(1): 53-8
7. Pajarinen J, Lindahl J, Michelsson O, Savolainen V, Hirvensalo E. Pertrochanteric femoral fractures treated with a dynamic hip screw or a proximal femoral nail – A randomized stdy comparing post-operative rehabilitation. The Journal of Joint & Bone Surgery (Br). Jan 2005; 87(1): 76-81.
8. Klinger HM, Bams MH, Eckert M, Neugebauer R. A comparative study of unstable per and intertrochanteric femoral fractures treated with dynamic hip screw (DHS) and trochanteric press plate versus proximal femoral nail (PFN). Zentralbl Chri. 2005 Aug; 130(4): 301-6.
9. Reska M, veverkova L, Divis P, Konecny J. Proximal femoral nal (PFN) – A new stage in the therapy of extracapsular femoral fractures. Scripta Medica (BRNO) 2006 June 79(2); 115-22.
10. Pavelka T, Houcek P, Linhart M, Matejka J. Osteosynthesis of hip and femoral shaft fractures using the PFN-long. Acta Chir Orthop Traumatol Cech. 2007 Apr; 74(2): 91-8.
11. Gadegone WM, Salphale YS. Proximal femoral nail – an analysis of 100 cases of proximal femoral fractures with an average follow up of 1 year. International Orthopaedics 2007 June; 31(3): 403-8.
12. Kulkarni GS, Rajiv Limaye, Milind Kulkarni, Sunil Kulkarni. Current Concept Review Intertrochanteric Fractures. Indian Journal of Orthopaedics 2006 Jan; 40(1): 16-23.
13. Ozkan K, Eceuiz E, Unay K, Tasyikan L, Akman B, Abdullah E. Treatment of reverse oblique trochanteric femoral fractures with proximal femoral nail. International orthopaedics (2011) Vol 35 issue 4:595-598.
14. M.P. Anjum and N Hussain. Treatment of intertrochanteric femoral fractures with proximal femoral nail: A short follow up. Nepal medical coll J 2009; 11(4):229-231.
15. Morihara, Y Arai, S Tokugawa, S fujitha, K Chatani, T Kubo. Proximal femoral nail for treatment of trochanteric femoral fractures. Journal of orthopaedic surgery 2007; 15(3): 273-7.