Annexure-ii proforma for registration of subject for dissertation

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
BANGALORE, KARNATAKA,
ANNEXURE-II
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1	NAME OF THE CANDIDATE	Dr. MANJU ADITHYA NAYAK .B.S
	ADDRESS	No 85,10^TH CROSS, NANJAPPA LAYOUT, VIDYARANYAPURAM, BANGALORE-97.
2	NAME OF THE INSTITUTION	BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, BANGALORE.
3	COURSE OF STUDY AND SUBJECT	M.S IN ORTHOPAEDICS
4	DATE OF ADMISSION	10^TH MAY 2010
5	TITLE OF THE TOPIC	STUDY OF SURGICAL MANAGEMENT OF DISTAL FEMORAL FRACTURES BY DISTAL FEMORAL LOCKING COMPRESSION PLATE OSTEOSYNTHESIS.

6. BRIEF RESUME OF INTENDED WORK
6.1. NEED FOR STUDY:
Fractures of the distal femur are complex injuries that can be difficult to manage. These fractures often are unstable and comminuted and tend to occur in elderly or multiply-injured patients. These serious injuries have the potential to produce significant long-term disability. It is now recognized by most orthopaedic surgeons that distal femoral fractures are best treated with reduction and surgical stabilization. Anatomic reduction of the articular surface, restoration of limb alignment, and early mobilization have been shown to be effective ways of managing most distal femoral fractures. Though various treatment options are available for the management of these injuries, experience with use of locking compression plate which combines fixed-angle locking screw technology with the option for conventional screw utilization is still very limited and more study is required to define its place in the management of distal femur fractures.

Considering the number of cases of distal femoral fractures coming to our hospital, I intend to study our experience , technical requirements, clinical results, radiological results, pit falls, complications and out comes in the use of these distal femoral locking compression plates both in supracondylar and intercondylar fractures of distal femur.

6.2. REVIEW OF LITERATURE:

1. Campbell e tal stated that the supracondylar and intercondylar fractures of the distal femur historically have been difficult to treat. Locking condylar plate fixation is indicated for intraarticular and extraarticular condylar fractures, buttressing of multifragmentary distal femoral fractures, bridging of high-comminuted distal femoral fractures, and treatment of distal femoral malunions¹.

2. Rock wood e tal stated that operative treatment was recommended for all fractures of the distal femur, with the exception of simple, nondisplaced fractures. LCP provides 3 times greater stability than a standard lateral condylar buttress plate and about 2.5 times greater stability than a 95-degree condylar plate in axial loading . Biomechanically this is explained by the fact that the LCP also uses multiple screws for metaphyseal fixation².

3. Winsten Gwathemey e tal concluded that surgery has become the standard of care for displaced distal femoral fractures and for patients who must obtain rapid return of knee function. A variety of surgical exposures, techniques, and implants has been developed to meet these objective, including intramedullary nailing, screw fixation, and periarticular locked plating, possibly augmented with bone fillers³.

4. Higgins TF e tal concluded that significantly greater subsidence (total axial displacement) occurred with the blade plate than with the locking plate fixation after cyclic loading. In load-to-failure testing, force absorbed by the locking plate before failure was significantly greater than the load tolerated by the blade plate construct. Variability in bone mineral density did not affect the findings.
The locking screw-plate construct proved stronger than the blade plate in both cyclic loading and ultimate strength in biomechanical testing. Although differences were small, the biomechanical performance of the locking plate construct over the blade plate may lend credence to use of the locking plate versus the blade plate in the fixation of comminuted distal femur fractures⁴.

5. V. Sharma e tal concluded that Distal femoral locking plates offer more fixation versatility without an apparent increase in mechanical complications or loss of reduction⁵.

6. Hernanz e tal concluded that the locking compression plate system for distal femoral fractures to be a safe and reliable procedure. The new system offers numerous fixation possibilities and has proven its worth in complex fracture situations⁶.

7. Mongkon Luechoowong e tal concluded that Locking compression plating is useful in treatment of complex distal femoral fractures, resulting in decrease operative time, complication rate and low infection rate. It may be substitute to a conventional plate and screw system in treatment of complex fracture of distal femur, especially osteoporotic bone⁷.

8. Kim KJ e tal concluded that internal fixation using locking compression plate for AO type C distal femoral fractures provided excellent fixation⁸.

9. WANG Ya-quan e tal concluded that less wound to the body and less interference to soft tissue would be obtained by using locking compression plate with a minimally invasive wound to treat complex distal femur fracture caused by high energy trauma, which would provide and maintain a stable fixation, facilitate early healing of fracture and reduce the complications⁹.

6.3. AIMS AND OBJECTIVES OF STUDY:

1. 
   To study the efficacy, technical requirements, functional results, radiological results, pitfalls, complications & out comes.
   

2. To Study of union rate and Time of Mobilization.
7. Materials and methods:
7.1. SOURCE OF DATA:

Patients admitted with distal femoral fractures in in-patient department of orthopaedics in Victoria hospital and Bowring & Lady Curzon Hospital attached to Bangalore Medical College & Research Institution.

7.2. METHOD OF COLLECTION OF DATA:

Collection of data from patients a minimum of 30 cases coming with fractures of distal femur to Victoria and Bowring & Lady Curzon hospitals for a period of 11/2 years from June 2010 to November 2011 as follows:

• 
  History by Verbal communication with patients and their attenders.
  
• 
  Clinical examination, both local and systemic.
  
• 
  Diagnosis : Clinical and Radiological.
  
• 
  Base line investigation.
  
• 
  Basic Radiological Examination.
  
• 
  CT scan in selected cases.
  
• 
  Surgery- Closed/Open reduction and internal fixation with Distal Femoral Locking compression plate(DF-LCP).
  
• 
  Routine Antibiotics and Analgesics/ Anti-inflammatory drugs.
  
• 
  Post-Operative evaluation by clinical and radiological examination.
  
• 
  Post operatively wound healing, complications, time for union, weight bearing, ambulation will be assessed, initially on weekly basis at 4weeks, 8weeks and 12 weeks followed by monthly basis at 4 months, 6 months, 8 months, 10 months.
  

INCLUSION CRITERIA:

1. 
   Closed distal femur fractures A1, A2 ,A3 ,C1 ,C2 ,C3 types of Orthopaedic Trauma Association (AO/OTA) classification.
   
2. 
   Patients of age 18 yrs and above both males and females.
   
3. 
   Patients with comorbid diseases like diabetes mellitus, hypertension, asthma, epilepsy and other medical conditions with closed distal femoral fractures.
   
4. 
   Osteoporotic fractures.
   

EXCLUSION CRITERIA:

1. 
   Compound fractures of distal femur.
   
2. 
   Closed distal femur fractures B1, B2, B3 types of Orthopaedic Trauma Association (AO/OTA) classification.
   
3. 
   Pathological fractures.
   
4. 
   Pregnancy.
   
5. 
   Peri-prosthetic fractures.
   
6. 
   Patients of age group < 18 years.
   
7. 
   Patients unfit for surgery.
   

Statistical analysis will be done by using appropriate statistical test.

7.3. Does the study require any investigation or interventions to be conducted on patients or other humans or animals. If so please describe briefly.

• 
  Investigation includes routine blood , radiological examination, CT scan in selected cases.
  
• 
  Surgery includes Closed/Open reduction and internal fixation with distal femoral locking compression plate will be done for the patients included in the study.
  
• 
  No animal studies required.
  

7.4. Study design: Prospective Study.
7.5. Has the ethical clearance obtained from your institution.

Will be furnished by the Principal of Bangalore Medical College and Research Institution.

8. LIST OF REFERENCES:

1. 
   Terry canale and Beaty: Campbell’s Operative orthopedics/11^th edition/ vol 3/Part 15/chap 51/page no 3170-3190 .
   

2. 
   Rock wood and Green’s fractures in adults/ 6^th edition/vol 2/section four- lower extremity/chap 48/page no 1915-1936.
   

3. 
   Distal Femoral Fractures: Current Concepts F. Winston Gwathmey, Jr, MD, Sean M. Jones-Quaidoo, MD, David Kahler, MD, Shepard Hurwitz, MD and Quanjun Cui, MD; J Am Acad Orthop Surg, Vol 18, No 10, October 2010, 597-607.
   

4. 
   Biomechanical analysis of distal femur fracture fixation: fixed – angle screw – plate construct versus condylar blade plate; Higgins TF,Pittman G,Hines J e tal: J Orthop Trauma 2007 Jan; 21(1) :43-6.
   

5. 
   Use of Distal Femoral LCP in fractures of Distal Femur and Periprosthetic fractures – Functional and Radiological results in 41 consecutive cases ; V. Sharma; Gale; R.Mansouri; and M. Maqsood; Journal of Bone and Joint Surgery – British Volume, Vol 92-B, Issue Supp_IV, 559- 2010.
   

6. 
   New screw- plate fixation systems with Angular Stability(LCP, LISS) for Complex fractures. Prospective study of 23 fractures with a follow up of 20 months; Hernanz- Gonzalezy, Diaz-Martin A, Jara Sanchez F, and Resines Erasun C; Journal of Bone and Joint Surgery –British Volume, Vol 88-B, Issue Supp_I- 170: 2006.
   

7. 
   The Locking Compression Plate (LCP) for Distal Femoral Fractures ; Mongkon Luechoowong; Buddhachinaraj Medical journal, Vol.25 (Supplement 1) January- April 2008.
   

8. 
   Surgical Treatment of AO Type C Distal Femoral Fractures Using Locking CompressionPlate(LCP-DF)  ; Kim KJ, Lee SK, Choy WS, Kwon WC, Lee DH ;
   

J Korean Fract Soc. 2010 Jan ;23(1): 20-25. Korean.

9. 
   Journal of Occupational Health and Damage: 2009-06 ; Application of locking compression plate in treatment of complex distal femoral fractures ; WANG Ya-quan, ZHOU De-chun, WANG Jin-quan e tal. Department of orthopaedics, Meishan Traditional Chinese Medicine Hospital, Meishan-662010, Sichuan province, China.
   

9. SIGNATURE OF THE CANDIDATE:
10. REMARKS OF THE GUIDE:	Fractures of distal femur are complex injuries which can produce significant long term disability. They are usually treated by closed/open reduction and stabilization surgically by implants. Success of surgical management includes anatomic reduction of articular surface, restoration of limb alignment and early mobilization. Experience with the use of distal femur locking compression plate is still very limited and more study is required.
11. NAME & DESIGNATION OF 11.1 GUIDE SIGNATURE: 11.2 HEAD OF THE DEPARTMENT SIGNATURE:	Prof. DR . RAMESH KRISHNA M.S.ORTHO Professor of Orthopaedics Department of Orthopaedics BMC & RI Prof. DR .N. VIJAYA KUMAR M.S.ORTHO Professor and Head Department of Orthopaedics BMC & RI
12. REMARKS OF THE CHAIRMAN AND PRINCIPAL: SIGNATURE: