RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
BANGALORE, KARNATAKA.
ANNEXURE –II
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
1. / Name of the candidate / DR. SANDEEP. K.MAddress / ROOM 58, BMC MENS PG HOSTEL, AV ROAD CHAMRAJPET, BANGALORE- 18
2. / Name of the institution / BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, BANGALORE.
3. / Course of
Study and
Subject / POSTGRADUATE
M.S. ORTHOPAEDICS
4. / Date of
Admission / 1st JUNE 2011
5. / Title of the topic / A PROSPECTIVE STUDY OF CLINICAL AND FUNCTIONAL OUTCOME OF PROXIMAL FEMORAL FRACTURES MANAGED WITH PROXIMAL FEMORAL NAIL
6. / Brief resume of intended work
6.1. Need for study:
Fractures of the proximal femur and hip are relatively common injuries in adults. Several epidemiological studies have suggested that the incidence of fractures of the proximal femur is increasing. More than 280,000 hip fractures occur in the United States every year, and this incidence is expected to double by 2050. These fractures are associated with substantial morbidity and mortality.1
Dissatisfaction with use of a sliding hip screw in unstable fracture patterns led to the development of intramedullary hip screw devices. This design offers potential advantages like more efficient load transfer, decrease tensile strength on the implant, controlled fracture impaction, reduces amount of sliding and therefore limits limb shortening and deformity, shorter operative time and less soft tissue dissection potentially resulting in decreased overall morbidity.2
Rapid strides in implant and instrumentations in quest of ideal fixation of pertrochanteric and subtrochanteric femoral fractures have made various options available like fixed angled nail plate, screw plate , angled blade plate, dynamic hip screw etc. The present study aims to study the role of Proximal femoral nail as a minimal invasive device in the management of these fractures and its clinical and functional outcome.
6.2 Review of literature:
Gadegone.W.M and Sulphale.Y.S made out numerous variations of intramedullary nails to achieve stable fixation and early fixation and early mobilisation in pertrochanteric, intertrochanteric and subtrochanteric fractures most important one is Proximal femoral nail which offers high rotational stability of the head neck fragment, an unreamed implantation technique and possibility of dynamic or static distal locking.3Morihara.T, Arai.Y et al 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.4
Reska M, Veverkova L et al found out that Proximal femoral nail is associated with less incidence of post operative dislocation or instability compared to Dynamic hip screw. This method was also used in laterocervical and stable pertrochanteric fractures due to its mini invasiveness. The preliminary experiences has confirmed the advantages of Proximal femoral nail if compared with other present osteosynthetic methods.5 Christian boldin, Franz J Seibert concluded that Proximal femoral nail is a good minimal invasive implant of unstable proximal femoral fractures if closed reduction is possible. If open reduction is necessary and several fragments found then Dynamic hip screw is preferred.6
Anjum MP and Husssain N 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.7 Klinger HM, Boums MH et al showed that the Dynamic hip screw/ Trochantric butt press plate osteosynthesis in instable trochanteric fractures is associated with higher incidence of complications therefore instable fractures of trochanteric region should be treated with Proximal femoral nail.8
Banan H, Al sabti showed Proximal femoral nail is better implant in subtrochanteric fractures but it can also be used in unstable trochanteric fractures with promising results.9
Ozkan K, Eceui E et al 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.10
6.3. Aims and Objectives of the study:
1.To study the profiles of patients with proximal femoral nail.
2.To study efficiency & healing and functional outcome of fractures treated
with Proximal femoral nail.
7. / Materials and methods
7.1. Source of Data
Adult patient of either sex having intertrochanteric fractures or subtrochanteric fractures who are admitted in Victoria and Bowring & Lady curzon hospitals attached to Bangalore medical college & Research institute.
7.2. Method of collection of data:
A. Study design: A prospective study.
B. Study period: Nov 2011 to May 2013.
C. Place of study: Victoria hospital and Bowring & Lady Curzon hospitals.
D. Sample size: It is a hospital based study of 30 cases who are fulfilling the
Inclusion/Exclusion criteria.
E. Inclusion criteria:
1. Patients who are medically fit for surgery and who have given
written informed consent for the procedure.
2. Adult patients aged more than 18 years.
3. Patients with Intertrochanteric and subtrochanteric fractures.
F. Exclusion criteria:
1. Intra capsular Fracture neck of femur.
2. Patients less than 18 yrs of age.
3. Patients not willing for surgery, patient medically unfit for
Surgery.
G. Methodology:
Inpatients of Victoria and Bowring & Lady Curzon hospital with proximal femoral fractures fulfilling the inclusion & Exclusion criteria will be taken in to study after obtaining written informed consent. Demographic data, History, Clinical examination and details of investigations will be recorded in the study proforma. The assessment tools used are Radiological union and Harris hip score.
Follow up: Clinical follow up at 6 weeks, 3 months, 6 months, 12 months
regarding disability and functional outcome will be
evaluated with the use of radiological fracture union and
Harris hip score. Any investigations during this time will be done.
H. Statistical method: ANOVA test
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
It does not require any animal study.
Yes, the patients will be subjected to the following relevant investigations:
-Haemogram, Bleeding time, Clotting time.
-Blood grouping and cross matching.
-Random blood sugar, Blood urea, Serum creatinine.
-Electrocardiogram
-X ray for fracture anatomy assessment Antero posterior & lateral view, preoperatively, immediate post operatively & at follow up.
-Routine radiological examination (chest x ray) & any other imaging modalities
7.4. Has the ethical clearance been obtained from your institution in the
case of 7.3?
Yes.
8. / List of references:
1.Lavelle DG. Fracture and dislocations of hip. Canale ST, Beaty JH
Campbell's operative orthopaedics. Elsevier inc. 11th edn; Vol 3, 2008;
Ch 52: 3237.
2. Kovel JK, Cantu VR. Intertrochanteric fractures. Buchloz, Robert W,
Heckman, James D. Rockwood & Green's fractures in adults. Lippincott
williams & wilkins inc. 6th ed vol-1, 2006; ch 45:1804
3. W.M.Gadegone and Y.S. Sulphale. Proximal Femoral Nail- An analysis of
100 cases of proximal femoral fractures with an average follow up of 1 year;
International orthopaedics (SICOT) (2007) 31 : 403-408.
4. T. 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
5. Reska M, Veverkova L, DIVIS.P, Konecny J. Proximal femoral nail(PFN)-
A new stage in the therapy of extra capsular femoral fractures. Seripta
MEDICA (BRNO) 2006; 79(2): 115-122.
6. Boldin C, Seibert FJ, Fankhauser F, Peicha G, Grechenig W, Szyszkowitz R.
The proximal femoral nail(PFN)- a minimal invasive treatment of unstable
proximal femoral fractures. A prospective study of 55 patients with a follow
up of 15 months. Acta orthop scand 2003; 74(1):53-58.
7. 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.
8. Klinger HM, Boums MH, Eckert M, Neugebover R. A comparative study of
unstable per & intertrochanteric femoral fractures treated with dynamic hip
screw(DHS) & trochanteric butt press plate vs proximal femoral Nail(PFN).
Zentrolbl chir 2005; Aug: 130(14):301-6.
9. Banan H, Al Sabti, Jimulia T, Hart AJ. The treatment of unstable,
extracapsular hip fractures with AO/ASIF proximal femoral nail(PFN) Our
first 60 cases. Injury[2002,33(5):401-5].
10. 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.
9. / Signature of the candidate: / (Dr. SANDEEP KM)
10. / Remarks of the Guide:
Proximal femoral nail has many advantages to fix fractures of the proximal femur. It is intramedullary device with lower bending movement and more load sharing than other implants. It helps in biological healing when closed methods are used. In context of these things the study is very relevant.
11. / Name and Designation
11.1.Guide:
11.2. Signature: / Dr. RAMESH KRISHNA. K
MBBS, MS (ortho), Mch (ortho), FAS, FTO
Professor and Head of dept.
Dept. of Orthopedics
Victoria hospital, Bangalore. 560002
11.3 Co-guide (if any):
11.4. Signature:
11.5.Head of the Department:
11.6. Signature: / Dr. MANJUNATH. K .S
D ortho, DNB (ortho)
Professor and Head of the Dept.
Dept. of orthopaedics
Bangalore medical college & Research institute, Bangalore. 560002
12 / 12.1.Remarks of the Chairman and Principal:
12.2 Signature: / Dr.O.S.SIDDAPPA
M.S,MCH
DEAN AND DIRECTOR
BANGALORE MEDICAL COLLEGE & RESEARCH INSTITUTE
BANGALORE. 560002
ANNEXURE I
I, Mr/Mrs/Ms______, exercising my own free will power of choice, hereby give consent for myself as an object in the A PROSPECTIVE STUDY OF CLINICAL AND FUNCTIONAL OUTCOME OF PROXIMAL FEMORAL FRACTURES MANAGED WITH PROXIMAL FEMORAL NAIL conducted by Dr. Sandeep.K.M, post graduate in orthopaedics under the guidance of Dr.Ramesh Krishna, Professor, Department of orthopaedics, Bangalore Medical College and Research Institute.
The attending doctors have informed me to my satisfaction and in the language best understood by me, the purpose of this study, the materials to be used during the course of this study as well as the side effects / complications associated with the methods/tools to be used.
I shall not hold the doctors or the staff responsible for any untoward consequences.
I am also aware of my right to opt out of the study without prejudice to further treatment at any time during the course of the study without having to give any reasons to do so.
Signature of the attending doctor:
DATE:
Signature of the witness: Signature/Left thumb DATE: impression of the patient
ANNEXURE III
Harris hip score Hip ID: Study Hip: Left Right
Examination Date(MM/DD/YY): / /
Subject Initials: ______
Medical Record Number:
Interval: ______
Pain (check one)
None or ignores it (44)
Slight, occasional, no compromise in activities (40)
Mild pain, no effect on average activities, rarely moderate
pain with unusual activity; may take aspirin (30)
Moderate Pain, tolerable but makes concession to pain.
Some limitation of ordinary activity or work. May require
Occasional pain medication stronger than aspirin (20)
Marked pain, serious limitation of activities (10)
Totally disabled, crippled, pain in bed, bedridden (0)
Limp
None (11)
Slight (8)
Moderate (5)
Severe (0)
Support
None (11)
Cane for long walks (7)
Cane most of time (5)
One crutch (3)
Two canes (2)
Two crutches or not able to walk (0)
Distance Walked
Unlimited (11)
Six blocks (8)
Two or three blocks (5)
Indoors only (2)
Bed and chair only (0)
Sitting
Comfortably in ordinary chair for one hour (5)
On a high chair for 30 minutes (3)
Unable to sit comfortably in any chair (0)
Enter public transportation
Yes (1)
No (0)
Stairs
Normally without using a railing (4)
Normally using a railing (2)
In any manner (1)
Unable to do stairs (0)
Put on Shoes and Socks
With ease (4)
With difficulty (2)
Unable (0)
Absence of Deformity (All yes = 4; Less than 4 =0)
Less than 30° fixed flexion contracture Yes No
Less than 10° fixed abduction Yes No
Less than 10° fixed internal rotation in extension Yes No
Limb length discrepancy less than 3.2 cm Yes No
Range of Motion (*indicates normal)
Flexion (*140°) ______
Abduction (*40°) ______
Adduction (*40°) ______
External Rotation (*40°) ______
Internal Rotation (*40°) ______
Range of Motion Scale
211° - 300° (5) 61° - 100 (2)
161° - 210° (4) 31° - 60° (1)
101° - 160° (3) 0° - 30° (0)
Range of Motion Score ______
Total Harris Hip Score ______