Place: Bellary

Date:

From,

Dr. GANESH. P. SUBBAIAH

Post Graduate Student in M.S Orthopaedics.

Dept. of Orthopaedics,

VIMS, Bellary.

To,

The Principal,

Vijayanagar Institute Of Medical Sciences,

Bellary.

THROUGH PROPER CHANNEL

Respected sir,

Subject: Acceptance of registration and forwarding of dissertation topic,

In accordance with the above cited subject, I undersigned studying Post Graduate Course in M.S Orthopaedics have been alloted the dissertation topic “ SURGICAL MANAGEMENT OF FRACTURE DISTAL END OF FEMUR AND PROXIMAL END OF TIBIA USING LOCKING COMPRESSION PLATE : A PROSPECTIVE STUDY AT VIMS HOSPITAL, BELLARY”, under the guidance of Dr. PRABHANJAN KUMAR. D Professor and Head Of the Department, Department of Orthopaedics, VIMS, Bellary.

I request you to kindly forward the dissertation topic in the prescribed form to the University for Approval.

Thanking you,

Yours faithfully,

DR. GANESH. P. SUBBAIAH

Signature of the guide

(Dr PRABHANJAN KUMAR. D)

Professor and Head of the Department

Dept. of Orthopaedics,

VIMS, Bellary.

Place: Bellary

Date:

From,

The Professor & Head of the Department,

Department of Orthopaedics,

VIMS, Bellary.

To,

The Registrar,

Rajiv Gandhi University of Health Sciences,

Bangalore.

THROUGH PROPER CHANNEL

Respected sir,

As per the regulations of the University of registration of Dissertation topic, the following Post Graduate student in M.S. Orthopaedics has been allotted the dissertation topic as follows by the Official Registration Committee of all qualified and eligible guides of the Department of Orthopaedics.

NAME / TOPIC / GUIDE
DR. GANESH. P. SUBBAIAH.
Post Graduate Student in M.S. Orthopaedics
Dept. of Orthopaedics,
VIMS, Bellary. / “SURGICAL MANAGEMENT OF FRACTURE DISTAL END OF FEMUR AND PROXIMAL END OF TIBIA USING LOCKING COMPRESSION PLATE : A PROSPECTIVE STUDY AT
VIMS, HOSPITAL BELLARY”. / Dr PRABHANJAN KUMAR. D
Professor and Head of the Department
Dept. of Orthopaedics,
VIMS, Bellary

Therefore, I kindly request you to communicate the acceptance of the dissertation topic allotted to the PG student at an early date.

Thanking you,

Yours faithfully,

Signature of the guide

(Dr PRABHANJAN KUMAR. D) (Dr PRABHANJAN KUMAR. D)

Professor and Head of the Department Professor and HOD

Dept. of Orthopaedics, Dept. of Orthopaedics,

VIMS, Bellary. VIMS, Bellary.

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

KARNATAKA, BANGALORE

ANNEXURE—II

PROFORMA FOR REGISTRATION OF SUBJECT FOR

DISSERTATION

1. / NAME OF THE CANDIDATE AND ADDRESS (in block letters) / DR. GANESH. P. SUBBAIAH
POST GRADUATE STUDENT IN MS ORHOPAEDICS, VIMS, BELLARY-583 104
2. / NAME OF THE INSTITUTION / VIJAYANAGAR INTITUTE OF MEDICAL SCIENCES, BELLARY
3. / COURSE OF STUDY AND SUBJECT / MS ORTHOPAEDICS
4. / DATE OF ADMISSION TO THE COURSE / 31-05-2007
5. / TITLE OF THE TOPIC:
“SURGICAL MANAGEMENT OF FRACTURE DISTAL END OF FEMUR AND PROXIMAL END OF TIBIA USING LOCKING COMPRESSION PLATE: A PROSPECTIVE STUDY AT VIMS HOSPITAL BELLARY”.
6. / BRIEF RESUME OF THE INTENDED WORK:
6.1 NEED FOR THE STUDY:
Fracture distal end of femur and proximal end of tibia involving articular surfaces historically have been difficult to treat. These fractures are often unstable, comminuted and tend to occur in elderly osteoporotic or multiply injured patients. Because of the proximity of involvement of these fractures to the knee joint, regaining full knee motion and function may be difficult. The incidence of malunion, non-union and infection are relatively high in many reported series. These serious injuries have the potential to produce significant long term disability 1, 2.
Before the development of techniques and implants to provide stable fixation, most of the distal femoral and proximal tibial fractures were treated with traction and cast bracing 5, 6. With the development of improved fixation devices by the A.O Group, treatment of these distal femoral and proximal tibial fractures were revolutionized 7 - 12. Various fixation devices for distal femoral and proximal tibial fracture fixation includes, interfragmentary lag screws, 95 degree blade plate, dynamic condylar screws, antegrade intramedullary screws, retrograde intramedullary nails and locking compression plates 1 - 4. Controversy remains for the optimal device for these fracture fixation.
Locking compression plate device offers potential bio-mechanical advantages over other above mentioned methods by 13-17
·  Better distribution of forces along the axis of bone
·  They can be inserted with minimal soft tissue stripping using minimally invasive percutaneous plate osteosynthesis (MIPPO)
·  Substantially reducing failure of fixation in osteoporotic bones
·  Reducing the risk of a secondary loss of intraoperative reduction by locking the screws to the plate
·  Unicortical fixation option
·  Better preservation of blood supply to the bone as the locked plating does not rely on plate/bone compression
·  Providing stable fixation by creating a fixed angle construct and angular stability
·  Early mobilization
Locking compression plate has the added advantage of the ability to manipulate and reduce the small and often osteoporotic fracture fragments directly.
6.2 REVIEW OF LITERATURE:
Before the introduction of stable fixation by the AO group, fracture distal end of femur and proximal end of tibia were treated in skeletal traction and cast bracing 5,6, because the technique of open reduction and internal fixation and implants available for fixation at that time were very limited. As a result, open reduction and internal fixation was rarely attempted and condemned as a method of treatment. This is well borne out in two major publications on this subject of the mid 1960s.
The condylar blade plate, a fixed angle-plating device for the treatment of the fractures of the distal femur was introduced by the AO group in the early 1960s. In 1979, Schatzkar and Lambert in a continuation of the 1974 study, reported on 34 supracondylar fractures treated with internal fixation. Overall, a good to excellent result was obtained in only 49% of the cases. The authors then critically evaluated the postoperative radiographs to determine which fractures were anatomically reduced with stable internal fixation in accordance with AO/ASIF principles. 17 of the 35 met the criteria with 71% good to excellent results, whereas the 18 that did not meet the criteria had only 21% good to excellent results. This study demonstrated that, if surgery is undertaken its success will be greatly enhanced if the surgeon adheres meticulously to the techniques and principles of rigid fixation as described by the Swiss. The mere use of best-designed implants does not guarantee good surgical results 7,8.
Marti, Andreas and colleagues conducted a study on Bio-mechanical evaluation of the less invasive stabilization system for the internal fixation of distal femoral fractures using monocortical screw fixation technique and observed enhanced ability to withstand high loads with angular stability 13.
Cole, Peter A. MD and Colleagues studied on proximal tibial fracture using the Less Invasive Stabilization System in which 91% (Total of 77 patients) healed without major complications and concluded that LISS provides stable fixation (97%), high rate of union, (97%) and a low rate of infection (4%) for proximal tibial fractures 14.
Egol, Kenneth A et al conducted study on the treatment of complex tibial plateau fracture using less invasive stabilizing system on 38 patients. The cohort of patients was evaluated clinically and radiographically for outcomes at a mean 15 months and observed 36 of 38 (95%) patients united at 4 months after surgery with no loss of fixation nor infection. Significant loss of knee range of motion was seen in only 5 patients 15.
Sommer et al reported very good outcome of surgical magement with locking compression plate in their retrospective study of 90 patients older than 70 years with osteoporosis who were treated usinglocking compression plate 16.
EJ Yeap and colleagues conducted a retrospective review of 11 patients with distal femoral fracture fixed with titanium distal femoral locking compression plate (DF-LCP) with the patients age ranging from 15 to 85 years with a mean of 44. clinical assessment was conducted atleast 6 months post operatively using the Schatzker scoring system. Results showed that 4 patients had excellent results, 4 good, 2 fair and 1 failure 17
6.3 OBJECTIVES OF THE STUDY:
1.  To study the outcome of surgically managed fracture of lower end of femur and upper end of tibia using locking compression plate.
2.  To reestablish the anatomy of articular surface of lower end of femur and upper end of tibia and knee joint perfectly by operative treatment with internal fixation.
3.  To assess the union of fractures after surgical treatment.
4.  To assess the range of motion of knee joint after surgical management.
7. / MATERIALS AND METHODS
7.1 SOURCE OF DATA:
The data for this study will be collected from the patients admitted under Department of Orthopaedics of Vijayanagar Institute Of Medical Sciences Hospital, Bellary with closed fracture lower end of femur and/or upper end of tibia during the period from 1/08/2007 to 31/07/2009 treated surgically using locking compression plate. Those patients who are above the age group of 20yrs including elderly patients are selected for the study.
7.2 METHOD OF COLLECTION OF DATA(including sampling procedure, if any):
The study is a clinical, prospective and observational study conducted at Vijayanagar Institute Of Medical Sciences Hospital, Bellary. After obtaining a detailed history, a complete general physical and systemic examination, the patients will be subjected to relevant investigations. The complete data will be recorded in a specially designed Case Recording Form. The data collected will be transferred into a Master Chart which is subjected to statistical analysis by the bio statistician of our institution. Finally after the diagnosis, the patients are selected for the study depending on the Inclusion and Exclusion Criteria. Post operatively all cases will be followed up for a minimum period of six months.
INCLUSION CRITERIA:
1.  Those patients who are above the age of 20yrs and managed surgically are included in the study.
2.  Patients presenting with distal femoral and proximal tibial fractures with or without osteoporotic changes are included in the study .
EXCLUSION CRITERIA:
1.  Patients with open distal femoral fractures.
2.  Patients with open proximal tibial fractures.
3.  Children with distal femoral/ proximal tibial fractures in whom the growth plate is still open.
4.  Patients with pathological distal femoral/proximal tibial fractures other than osteoporosis.
5.  Patients lost in follow up.
6.  Patients managed conservatively for other medical reasons.
7.  Distal femoral/proximal tibial fractures with neurovascular compromise.
This is a prospective clinical study from 1/08/2007 to 31/07/2009. Minimum of 21 cases will be studied. Patients will be followed up for minimum of 6 months with each follow up, clinical and radiological evaluation will be done. Outcome (functional and radiological) will be evaluated using Neer’s 100 point knee rating scale assigned for each patient at 24 to 36 weeks. Outcome will be compared with previous reported series.
7.3 DOES THE STUDY REQUIRE ANY INVESTIGATION OR INTERVENTIONS TO BE CONDUCTED ON PATIENTS OR OTHER HUMANS OR ANIMALS? IF SO DESCRIBE BRIEFLY.
YES
In our study the following investigations are conducted in each patient. All the patients included in the study are investigated thoroughly with
·  Routine blood investigations ( Complete blood count, random blood sugar, serum urea, serum creatinine)
·  Urine routine ( Albumin, sugar, microscopy)
·  Radiological examination pre operatively are done.
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 under the direct guidance and 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 months.
7.4 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.3
YES, Ethical clearance has been obtained from VIMS INSTITUTIONAL ETHICS COMMITTEE, Bellary.
8. / List of References:
I. Text Book References
1.  Whittle AP, Wood II GW. Campbell’s operative orthopaedics, Chapter 51, In: Fractures of lower Extremity, 10th ed, Vol.3, Mosby Inc 2003.
2.  O’ Brien PJ, Meek RN, Blachut PA, Broekhuyse HM. Fractures of the distal femur: Rockwood and Green’s Fractures in Adults. Vol 2, 5th Ed, Lippincott Williams and Wilkins, 2001.
3.  Chapman’s Orthopaedics surgery, By Michael. W. Chapman. 3rd edition
4.  Skeletal Trauma By Browner, Jupiter, Levine, Trafton. By Jessi B. Jupiter and Michael D. Mckee. 2nd Edition, Vol 2
II. Journal References
5.  Stewart MJ, Sisk TD, Wallace SL. Fractures of the distal third of the femur. J Bone Joint Surg 1966;48A:784-807
6.  Neer CS, Grantham SA, Shelton ML. Supracondylar fracture of the adult femur. J Bone Joint Surg 1967; 49A: 591-613
7.  Schatzker J, Lambert DC. Supracondylar fracture of the femur. Clin Orthop 1979; 138: 77-83
8.  Schatzker J, Horne G, Waddell J. The Toronto experience with the supracondylar fracture of femur 1966 – 1972. Injury 1974; 6: 113 – 128.
9.  Laros GS. Supracondylar fractures of the femur. Editorial comment abd comparative results. Clin Orthop 1979; 138:9-12
10. Thomas TL, Meggit BF. A comparative study of methods for treating fractures of distal femur. J Bone Joint Surg 1981; 63B(1): 3-6
11. Giles JB, Delee JC, Heckman JD, Keever JE. Supracondylar – intercondylar fractures treated with a supracondylar plate and lag screw. J Bone Joint Surg 1982; 64A: 864-870
12. Healy WL, Brooker AF, Distal femur fractures: Comparision of open and closed methods of treatment. Clin Orthop 1983; 174: 166-171
13. Marti, Andreas; Fankhauser, Christoph; Frenk, Andre; Cordey Jacques*; Gasser, Beat, Biomechanical Evaluation of the Less Invasive Stabilization System for the Internal Fixation of Distal Femur Fractures. Journal of Orthopaedic Trauma 15(7):482-487, September/October 2001
14. Cole, Peter . MD*; Zlowodzke, Michael MD+; Kregor, Philip J. MD +. Treatment of proximal tibial fractures using the Less Invasive Stabilization System: Surgical Experience and Early Clinical Results in 77 Fractures. Journal of Orthopaedic Trauma 18(8):528-535, September 2004.
15. Egol, Kenneth A. MD; Su, Edward MD; Tejwani, Nirmal C MD; Sims, Stephen H. MD; Kummer, Frederick J. PhD; Koval, Kenneth J. MD. Treatment of Complex Tibial Plateau Fractures Using the Less Invasive Stabilization System Plate: Clinical Experience and a Laboratory Comparision with Double Plating. Journal of Trauma-Injury Infection and Critical Care. 57(2):340-346, August 2004.
16. Sommer, C. H.; Wullschleger, M.; Walliser, M.; Bereiter, H.; Leutenegger, A. Experience with Locking compression Plate in fracture treatment of osteoporotic bone. British Journal of Surgery, Vol 91(7), July 2004, page 912.
17. EJ Yeap, AS Deepak, Distal femoral Locking Compression Plate Fixation in Distal Femoral Fractures: Early Results. Malaysian Orthopaedic Journal 2007 Vol1 No1, Page No 12 - 17.
9. / SIGNATURE OF THE CANDIDATE: / Dr GANESH. P. SUBBAIAH
10. / REMARKS OF THE GUIDE:
11. / NAME AND DESIGNATION OF
(in block letters)
11.1 GUIDE / Dr PRABHANJAN KUMAR. D
Professor and Head of the Department
Dept. of Orthopaedics,
VIMS, Bellary.
11.2 SIGNATURE
11.3 CO.GUIDE (if any) / Dr SHIV NAIK,
Assistant Professor,
Dept. of Orthopaedics,
VIMS, Bellary
11.4 SIGNATURE
11.5 HEAD OF THE DEPARTMENT:
/ Dr PRABHANJAN KUMAR. D
Professor and Head of the Department
Dept. of Orthopaedics,
VIMS, Bellary.
11.6 SIGNATURE
12. / 12.1 REMARKS OF THE CHAIRMAN & PRINCIPAL
12.2 SIGNATURE

11