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. k.m.ponnanna
Post Graduate Student,
Department of Orthopaedics
SDM College of Medical Sciences And Hospital
Dharwad.
2. / Name of the Institution / SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL, DHARWAD.
3. / Course of Study and Subject / M.S.ORTHOPAEDICS
4. / Date of Admission to Course / 18-05-2012
5. / Title of the Topic / “A COMPARATIVE STUDY OF PROXIMAL FEMORAL NAIL VERSUS DYNAMIC HIP SLIDING PLATE AND SCREW SYSTEM FOR THE TREATMENT OF INTERTROCHANTERIC FEMORAL FRACTURES”
6. / Brief resume of the intended work:
6.1 NEED FOR STUDY:
In 1997 Gullberg et al. estimated that the future incidence of hip fracture worldwide would double to 2.6 million by 2025, and 4.5 million by 2050. The percentage increase will be greater in men (310%) than women (240%).Pertrochanteric femoral fractures are of intense interest globally. They are the most frequently operated fracture type, have the highest postoperative fatality rate of surgically treated fractures, and have become a serious health resource issue because of the high cost of care required after injury. Intertrochanteric fractures account for approximately half of the hip fractures in elderly. Most intertrochanteric femoral fractures occur in elderly individuals as a result of only moderate or minimal trauma. In younger patients, these fractures usually result from high energy trauma.
Pertrochanteric fractures are those occurring in the region extending from the extra capsular basilar neck region to the region along the lesser trochanter before the development of the medullary canal. Intertrochanteric fractures are mainly classified as stable and unstable fractures.
In 1949 Boyd and Griffin described the first treatment recommendation classification: (i) Stable (two part); (ii) unstable with posteromedial comminution; (iii) subtrochanteric extension into lateral shaft extension of the fracture distally at or just below the lesser trochanter ( reverse obliquity) and (iv) subtrochanteric with intertrochanteric extension with the fracture lying in at least two planes.
The OTA/AO classification is now the most quoted in recent scientific articles and is a derivative of the Muller classification. In the OTA alphanumeric fracture classification, intertrochanteric hip fractures comprise type 31A. These fractures are divided into three groups, and each group is further divided into subgroups based on obliquity of the fracture line and degree of comminution.
The goal of treatment of any intertrochanteric fracture in elderly is to restore mobility safely and efficiently while minimizing the risk of medical complications and technical failure and to restore the patient to the pre-operative status. Restoration of mobility in patients with unstable intertrochanteric fracture ultimately depends on the strength of surgical construct.
The controversy over the choice of implant specifically the use of intramedullary nails versus extra medullary plate of intertrochanteric fractures continues.
The Dynamic hip screw (DHS) has gained widespread acceptance in the last decade and is currently considered as the standard device for the comparison of outcomes.DHS has been shown to produce good results but complications are frequent, particularly in unstable pertrochanteric fractures. DHS fixation has been clearly assessed and randomized comparison have shown it to be superior to fixed nail plates.Enders nails, Kuntscher Y nails. The DHS has therefore become one of the standard treatments of intertrochanteric fractures.
Proximal femoral nail (PFN) was devised by the AO/ASIF group in the year 1996 for the treatment of intertrochanteric fractures and has proven to be a promising implant. Theoretically intramedullary fixation provides an improved biomechanical environment with a shorter lever arm, which provides more load shedding, indirect healing and allows less collapse to a stable medial configuration and thus enables early rehabilitation and weight bearing.PFN provides rotational stability.
Disadvantages are related to greater risk of stress at the tip of the nail and distal locking bolts.
Intramedullary nails are superior in the treatment of unstable intertrochanteric fractures, reverse oblique fractures and subtrochanteric fractures. However there is no clinical data supporting this, therefore controversy continues regarding the ideal choice of implant for the treatment of intertrochanteric femoral fractures.
Thus this study will help us to understand the surgical management of intertrochanteric fractures, complications associated and evaluate the functional outcome.
6.2 REVIEW OF LITERATURE:
1. In 2001 J. Pajarinen. Lindahl,O. Michelsson,V. Savolainen,E. Hirvensalo from Helsinki University Central Hospital, Helsinki, Finland conducted a study to determine whether patients who sustained intertrochanteric fracture have better outcome when stabilized using dynamic hip screw or proximal femoral nail. Patients treated with the proximal femoral nail had regained their pre-operative walking ability significantly more often by the four-month review than those treated with the dynamic hip screw. Peri-operative or immediate post-operative measures of outcome did not differ between the groups, with the exception of operation time. The dynamic hip screw allowed a significantly greater compression of the fracture during the four-month follow-up, but consolidation of the fracture was comparable between the two groups. Two major losses of reduction were observed in each group, resulting in a total of four revision operations.
Results suggest that the use of the proximal femoral nail may allow a faster postoperative
restoration of walking ability, when compared with the dynamic hip screw.
2.In 2004 Minos Tyllianakis,Andrea Panagopoulos, Andreas Papadopoulos, Socratis Papasimos, Konstantin’s Mousafiris performed a study to determine the treatment of Extra capsular hip fractures using Proximal femoral nail, published in the journal ACTA Orthopaedica Belgica. A total of 45 patients unstable pertrochanteric fractures (21 31-A2, 25 31-A3,) were available for outcome analysis. Mean follow-up period was 20 months. The Salvati and Wilson scale of hip function was used at the last follow-up clinical assessment. Solid union of the fracture was achieved in all patients except one who was revised to total hip arthroplasty because of avascular necrosis of the femoral head. Technical and mechanical complications were noted in 41.3% of the patients during the operation and in 30.4% at the follow-up period.2 cut-outs of the neck screw, 5 “Z effects” of the anti rotational hip pin leading to femoral head protrusion in four of these cases, 1 case with reverse “Zeffect”and 2 implant failures, both revised to a long PFN implant. The overall rate of re-operation was 28.8%. The Salvati and Wilson score was > 25 in 27(60%) of the patients. The PFN modifications might be responsible for the positive results in this study. Technical or mechanical complications seem to be related with the type of fracture, the operative technique and the time of weight bearing rather than the PFN system itself.
3. In 2008 Brain Aros,Anna N.A, Tosteson ScD, Daniel J, Kenneth J.Koval, in the journal “Association of Bone and Joint Surgeons” conducted a study to determine whether patients who sustain an intertrochanteric fracture have better outcomes when stabilized using a sliding hip screw or an intramedullary nail. The cohort consisted of 43,659 patients. Patients treated with an intramedullary nail had higher rates of revision surgery during the first year than those treated with a sliding hip screw (7.2% intramedullary nail versus 5.5% sliding hip screw). Mortality rates at 30days (14.2% intramedullary nail versus 15.8% sliding hip screw) and 1year (30.7% intramedullary nail versus 32.5% sliding hip screw) were similar. Adjusted secondary outcome measures showed significant increases in the intramedullary nail group relative to the sliding hip screw group for index hospital length of stay, days of rehabilitation services in the first 6months after discharge, and total expenditures for doctor and hospital services.
4. In 2009 Zhao C, Liu DY, Guo JJ, Li LP, Zheng YF, Yang HB, Sun JH in the article “Comparison of Proximal Femoral Nail and Dynamic Hip Screw for treating intertrochanteric fractures” studied 104 patients with intertrochanteric fractures. 33 patients were treated with proximal femoral nail (PFN) and 71 patients were treated with DHS. Comparison in, average time of operations, the length of incision, blood loss, weight loading time and complications between two procedures was done. An average time of operation was 52 min in PFN and 68 min in DHS. The length of incision was 9.6 cm in PFN and 15 cm in DHS. The blood loss was 179 ml in PFN and 269 ml in DHS. Varus collapse was none in PFN, 1 case in DHS. The collodiaphyseal angle of 7 cases decreased in DHS. Lateral hip pain caused by proximal screw removal was 6 cases in PFN.The study concluded stating; therapeutic effect of DHS and PEN was primitively same in treating type A1 of intertrochanteric fracture. Operative injuries of PFN were less than that of DHS and it was more suitable for type A2 and A3 of intertrochanteric fractures.
5.In 2009 J Zou, Y Xu and H Yang in the article “A Comparison of Proximal femoral Nail Ante rotation and Dynamic Hip Screw published in “The Journal of International Medical Research concluded stating, DHS required a longer operation time and was associated with greater blood loss compared to PFN. The re operation rate was lower in PFN compared to DHS especially in patients with unstable fractures. There were no significant differences in the functional outcome between PFNA group and DHS group. PFNA group is useful in the treatment of trochanteric fractures.
6.In 2011 R.N. Singh M.S. Ortho, FRCS, B.N. Singh M.S. Ortho, FRCS in the article “Comparative prospective study of proximal femoral nail and dynamic hip screw in treatment of intertrochanteric fracture femur published in the journal of clinical orthopaedics and trauma concluded that DHS was tolerated better by young patients with stable fracture while PFN
had a better outcome with osteoporotic patients and weak bone mass and reverse oblique fractures.
7.In 2011 NK Karn, Ashish Jain, P Nepal, Mahi Pal Singh,in the article “A Prospective Randomized Control Trial Comparing Proximal Femoral Nail and Sliding Hip Screw in The Management of Trochanteric Fracture of The Femur” published in the journal of Health Renaissance concluded that ,the number of patients showing shortening, external malrotation
and varus angulation was more in sliding hip screw group. There was one case of wound
infection and a single case of breakage of implant in sliding hip screw group. The amount of blood
loss and length of incision were significantly higher in the sliding hip screw.
8.CAMPBELL’S OPERATIVE ORTHOPEDICS , 11th edition , volume 3 , 3237- 3308.
Two broad categories of internal fixation devices are commonly used for intertrochanteric femoral fractures: sliding compression hip screws with side plate assemblies and intramedullary fixation devices.
The preferred type of device is controversial. Intramedullary nails have a biomechanical and biological advantage over standard compression hip screws. Intramedullary nails can be inserted with less exposure of fracture and less blood loss , although they require more fluoroscopic exposure and have been associated with fracture communition . Biomechanically nails allow for stable anatomical fixation of more comminuted fractures without shortening the abductor movement arm or changing the proximal femoral anatomy. These devices provide fracture stability by virtue of allowing lateral aspect of head and neck to come to rest against the nail in the medullary canal
9. ROCKWOOD AND GREEN’S FRACTURES IN ADULTS , seventh edition , volume 2 Intertrochanteric fractures by Thomas A Russel , 1597-1640.
The results of most studies that have compared intramedullary hip screws and sliding hip screws have revealed no significant differences with respect to operating time, duration of hospital stay, infection rate, wound complications, implant failure, screw cut-out, or screw sliding for stable fracture patterns . Patients treated with an intramedullary hip screw, however, have been at increased risk for femoral shaft fracture at the nail tip and the insertion sites of the distal locking screws.
6.3 AIM AND OBJECTIVES OF THE STUDY:
1. To compare Proximal Femoral Nail and Dynamic Hip Screw method of fixation in intertrochanteric fracture in adults with respect to intra operative parameters like total duration of surgery, blood loss and intraoperative complications.
2. To study the pattern of implant failure.
3. To compare the functional outcome with respect to union of the fracture, functional return, mortality and complications.
4. To determine the ideal implant for different fracture pattern so as to provide the best results with least complications.
5. To study the types of fracture patterns with respect to mode of injury, age of patients and grade of osteoporosis in the study group.
7. / Materials and Methods:
7.1 SOURCE OF DATA:
· Study subjects:
.Patients who have sustained Intertrochanteric Femur Fracture and who meet the inclusion criteria admitted in SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL DHARWAD.
Inclusion Criteria:
1.All Adult patients with intertrochanteric fractures.
2.Intertrochanteric Fracture (stable or unstable) confirmed with appropriate radiographs.
3.Patients who are medically fit for surgery.
4.Fractures less than two weeks
Exclusion Criteria:
1. Patients with compound and pathological fractures.
2. Patients with disorders of bone metabolism other than osteoporosis (i.e., Paget’s disease, renal osteodystrophy or osteomalacia.)
3. Pediatric age group.
4. Intertrochanteric fractures with reverse obliquity patterns and those with subtrochanteric extension.
5. Medically unfit for surgery.
6. Patient who are not willing for Surgical intervention
· Study area:
Department of Orthopaedics SDM College of Medical Sciences,Sattur Dharwad.
· Study period: November 2012 to October 2013
7.2 METHODS OF COLLECTION OF DATA:
· Study design:
The study will be prospective, time bound, hospital based randomized comparative study. Cases satisfying the inclusion criteria admitted in SDM medical college during the study period from November 2012 to October 2013 will be included. Patients will be followed up for a period of 3 months,6 months and 1 year and clinically evaluated with MODIFIED HARRIS HIP SCORE. The outcome will be used for evaluation.
· Sample:
Cases satisfying the inclusion criteria admitted in SDM medical college Dharwad during the period of November 2012 to October 2013 will be included. Considering the previous case records, on an average around 50 cases i.e. Proximal Femoral Nail (25) and Dynamic Hip Sliding Plate And Screw System (25) will be taken under this study.
· Sampling procedure:
RANDOMIZED SAMPLING
· Study instrument:
1. Proximal Femoral Nail
2. Dynamic Hip Sliding Plate And Screw System.
· Data collection:
1. All patient’s attended to by the department of orthopaedics at the SDM Hospital who fulfill the criteria mentioned previously
2. Evaluation of the pre-op clinical and X-ray status by an orthopaedic surgeon
3. Evaluation of the post-op clinical and X-ray results by 2 orthopaedic surgeons
Parameters used:
Name,
Age,
Sex,
Mode of injury ,
Clinical examination – Routine protocol for examination of the hip joint will be followed
X-ray Findings- Fractures will be classified as per AO/OTA Classification
· Study analysis:
Functional outcome will be analysed using MODIFIED HARRIS HIP SCORE.
The data collected will be evaluated using appropriate statistical tests.
7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? (If so, please describe briefly)
Yes, the study requires routine investigations and appropriate radiological investigations.
Investigations:
1) Basic investigations
· Hemoglobin %, Total WBC count, differential count ,ESR, Bleeding time, Clotting time
· Blood urea, Serum creatinine, Random blood glucose
· HIV,HbsAg,HCV
· ECG, 2D ECHO if required
· Doppler if required
2) Radiological investigations
· Plain X-ray of relevant parts in anteroposterior and lateral views
· Chest X-ray
· Traction and internal rotation X-rays if required
· CT Scan and 3D Reconstruction study if required.
7.4 Has ethical clearance been obtained from ethical committee of your institution in case of
Ethical clearance has been obtained from the ethical committee of SDM Medical College Dharwad
8. / List of References:
1.Brian Aros , Anna.N.A, Tostesonb ScD, Daniel J,et al. IS SLIDING HIP SCREW OR IM NAIL THE PREFERRED IMPLANT FOR INTERTROCHANTERIC FRACTURES , clinical orthop relat res.2008; 466: 2827-2832.
2.RN.Singh,BN.Singh.Comparitive prospective study of proximal femoral nail and dynamic hip screw In treatment of intertrochanteric fracture femur. Journal of Clinical Orthopaedic and Trauma.2012;3:28-36.
3 .Minos Tyllianakis,Andreas Panagopoulos,Andreas Papadopoulos, et al.Treatment of extracapsular hip fractures with the proximal femoral nail(PFN):Long term results in 45 patients.Acta Orthop.Belg.2004;70:444-454.
4. J.Pajarinen,J.Lindahl,O.Michelsson,et al. A Randomised Study Comparing Post-Operative Rehabilitation. J Bone Joint Surg Br.2005;87-B:76-81.
5. NK Karn, Ashish Jain,Mahi Pal Singh. A Prospective Randomized Control Trail Comparing Proximal Femoral Nail and Sliding Hip Screw in The Management of Trochanteric Fracture of The Femur. Health Renaissance.2011;9:7-11.
6.Zhao C,Liu DY,Guo J,et al.Comparision of Proximal femoral nail and dynamic hip screw for treating Intertrochanteric fractures.China journal of Orthopaedics and traumatology.2009;22(7):535-537.
7.Zou J,Xu Y, Yang H.A comparision of proximal femoral nail antirotation and dynamic hip screw Devices in trochanteric fractures.The Journal of International Medical Research.2009;37:1057-1064.
8. David G Lavelle.Hip Fractures In:S Terry Canale,James H.Beaty eds.Campbell’s Operative Orthopaedics,vol 3,11th ed.Missouri;Mosby Elsevier,2008.p.3237-3270.
9.Kenneth J.Koval,Robert V.Cantu.Intertrochanteric Fractures In:RobertW. Bucholz, JamesD. Heckman, Charles M.Court-Brown eds.Fractures in Adults,vol 2,6th ed.Philadelphia;Lippincott Williams & ilkins, 2006.p.1793-1825.
9. / Signature of the candidate / Dr.K.M.PONNANNA.
10. / Remarks of the guide / DHS has stood the ‘Test of Time’ over years.PFN is comparatively newer implant, hence it is worth while studying the efficacy of newer system. Hence the comparative study undertaken.
11. / Name and Designation
11.1 Guide / DR. CHANDRAKANTH D. NALLULWAR,
Professor & HOD,
Department Of Orthopaedics,
SDM College of Medical Sciences & Hospital,
Sattur, Dharwad.
11.2 Signature
11.3 Co-Guide
11.4 Signature
11.5 Head of the Department / DR. CHANDRAKANTH D. NALLULWAR,
Professor & HOD,
Department Of Orthopaedics,
SDM College of Medical Sciences & Hospital,
Sattur, Dharwad.
11.6 Signature
12. / 12.1 Remarks of the Principal and Chairman
12.2 Signature
VOLUNTEER’S CONSENT FORM