Annexure II proforma for registration of subjects for dissertation

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

KARNATAKA, BANGALORE.

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

	Name of the candidate, with address:	Dr. KARRI SANDEEP REDDY PG in Orthopaedics, Room no.330, New PG Hostel, MCC-B Block, Davangere-577004
	Name of the Institution:	JAGADGURU JAYADEVA MURUGARAJENDRA MEDICAL COLLEGE, DAVANGERE. 577004
	Course of study, and Subject:	Post-Graduation (MS) Orthopaedics
	Date of admission in the course:	1^st June, 2013
	Title of the Topic:	A STUDY OF MANAGEMENT OF PROXIMAL 3^rd TIBIAL FRACTURES USING MINIMALLY INVASIVE PLATE OSTEOSYNTHESIS(MIPO) WITH LOCKING COMPRESSION PLATES.
6. Brief resume of the intended work: 6.1 Need for the intended study: Tibia is a long tubular bone with triangular cross section and is responsible for 85% of weight bearing load and so is the most commonly fractured long bone. There is a high incidence of open fractures as one third of the tibial surface is subcutaneous. Tibial plateau fractures account for 1% of all fractures in adults and 8% in elderly where as proximal tibial diaphyseal fractures account for 7% of all tibial diaphyseal fractures. With the advent of antibiotics and modern techniques like plating and screw fixation of fracture fragments early mobilization was possible but bone healing and union and soft tissue complications still haunt most surgeons even today. ^1,2,3 Various clinical studies established that bone beneath a rigid conventional plate are thin and atropic which are prone for secondary displacement due to insufficient buttressing secondary fractures after removal of plate are more common Osteosynthesis takes longer time due to interruption of vascular supply to bone due to soft tissue and periosteal stripping Dr. Girdlestone in 1932 warned that “there is a danger inherent in the mechanical efficacy of our modern methods, danger lest the craftsmen forget that union cannot be imposed but may have to be encouraged. Where the bone is a plant, with its roots in the soft tissues, and when its vascular connection are damaged, it often requires, not the technique of a cabinet maker, but the patient care and understanding of a gardener.”^4 Hence if we desire a good fixation with minimal interference to the biology of the bone, this require a new thinking in the concept of implant as well as in the concept of internal fixation. This change of concept is what is termed as “Biological fixation”. The concepts of biological fixation consists of Indirect reduction Adequate stability Preservation of osteogenic potential Limited bone - plate contact^5 The concept of biological fixation gave rise to a new type of plate configuration called the LCP- locking compression plate, which acts as both an internal and external fixator due to its unique threaded configuration for the screw head. Therefore keeping the above problems and principles in mind I wish to study the effects of bone union and soft tissue healing in response to minimally invasive plate fixation for proximal 3^rd tibial fractures using LCPs 6.2 REVIEW OF LITERATURE: Fractures have been recognized and treated as long as recorded history. History of fracture and its knowledge dates back to Egyptian mummies of 2700 BC. For thousands of years the only option for the management of fracture was some form of external splintage. 5000 years ago, the Egyptians used palm bark and linen bandages for management of fractures. Clay and lime mixed with egg white were used, but the material most commonly used has been wood. Accordind to Sirkin et al Percutaneous fixation offers its best in isolated undisplaced fractures, split unicondylar fractures and in elderly osteoporotic bone. The advantages are decreased operative time, less blood loss, smaller incision, short hospital stay and early rehabilitation.^6 In the early half of the 20th century Palmer L reported two studies having satisfactory percentage of good to excellent short and long term results with surgical method of treatment.^7 In another published study of 159 cases of tibial plateau fracture of all types, treated by conservative (46%) and surgery (54%), evaluated by How and Luck method reported good excellent result in surgery (84%) than conservative method (62%).^8 Roberts in 1968 reported 100 cases of tibial condyle fractures treated by conservative and surgical. The results were good in 72% conservative, 80% traction mobilization and81% surgical. He advocates early mobilization preservation for menisci and repair of torn ligaments for best results. ^9 Schatzkar in 1979, reported 70 cases of tibial plateau fracture of all types treated by conservative (56%) and surgical (44%) with average follow up of 28 months. Acceptable results were obtained in 58% of cases of conservative group and 78% by open methods. Fracture treated by ORIF with buttress plate and bone grafting achieved 88% acceptable results.^10 A study of 278 cases of tibial plateau fracture with an average follow up of 2.5 years, all treated by surgical methods. 89% acceptable result when surgery was done by inexperienced surgeons, 97% when done by experienced. They concluded the prognosis improve with the experience and with accurate reconstruction of articular surface. They also said post traumatic osteoarthritis was directly proportional to the amount of displacement.^11 Lausinger O in 1986 did a 20 yrs follow-up of his earlier study extended in a series of 260 fractures of one of both condyles. 90% of the patients achieved an excellent good results and 10% achieved fair or poor results. The inferior results were seen in unstable split with depressed fractures.^12 Gonzailez HY et al studied 122 injuries in 113 patients treated with the LCP and LISS. They found that despite the large number of open and comminuted fractures no serious complications such as deep infections, nonunions, vascular lesions or deep venous thrombosis were noted. Also then concluded that the proven value of these systems (LCP and LISS) in complex fracture situations and revisions surgeries. They found the procedure to be safe and reliable.^13 Ring et al treated 24 patients with osteoporotic delayed union (9 patients) and non union (15 patients) of the humeral diaphysis with the locking compression plate. All the fractures eventually healed and using a modification of the constant and murley shoulder score the results were good or excellent in 22 patients and fair in 2 patients. They found that the construct provides stable fixation in patients with poor bone quality.^14 A study was conducted by Kropp et al on 58 bicondylartibial plateau fractures. A comparison was done between closed reduction internal fixation and external fixation. Results showed that, locking compression plate are associated with decreased time for union, decreased incidence of articular malunion, decreases knee stiffness and decreased overall complication. Locking plates allow the surgeon to place a biomechanically stable internal fixator on the lateral side of the proximal tibia through a limited surgical exposure^15 Sumit Arora et al in 2011 presented a case of proximal displaced tibial fracture that was treated with anatomical proximal tibial locking plate using minimally invasive percutaneous plate osteosynthesis. They concluded that “Patient made uneventful recovery even after he sustained re-injury and plate bending and was manipulated under anaesthesia for the same.”^16 Tantray et al in a study published in jan 2011 concluded that “ Minimally invasive plate osteosynthesis is a good and safe technique for treatment of tibial diaphyseal fractures providing fracture healing, rapid functional recovery, with minimal soft tissue damage and preservation of blood supply. It is a reliable approach for the management of tibial diaphyseal fractures with proper indications.”^17

6.3 OBJECTIVES OF THE STUDY:

• 
  To study the functional outcome of the knee following fractures of proximal 3^rd tibia after operating with LCP using MIPO/ biological fixation.
  
• 
  To study the advantages and disadvantages and complications of LCP and duration for union to occur in these fractures.
  

7. 
   MATERIAL AND METHODS:
   

1. 
   Source of Data:
   

• 
  Adult patients, both male and female admitted to Chigateri General Hospital, Davangere and Bapuji Hospital, Davangere attached to JJM medical college, Davangere with proximal tibial fractures wil be taken up for this study after obtaining proper informed and valid written consent.
  

7.2 Method of collection of data: (Including sampling procedures if any)

• 
  In this proposed study, a minimum of 20 patients presenting with proximal tibial fractures admitted in Bapuji hospital and Chigateri hospital, both in davangere attached to JJMMC,Davangere will be evaluated clinically and radiologically.
  
• 
  Fractures classification is by OA classification.
  
• 
  Routine preop investagations and anaesthetic checkup will be done to make sure they are fit for surgery.
  
• 
  Patients will then undergo Minimally Invasive Plate Osteosynthesis using Locking Compression Plates under Spinal Anaesthesia.
  
• 
  They will then be followed up at regular intervals and the following details will be studies
  

• 
  Post operative complications (if any)
  
• 
  Time for Fracture Union
  
• 
  Range of Movements
  
• 
  Patient satisfaction with his day to day activities
  
• 
  Time taken for patient to return to his pre fracture duties
  

Inclusion criteria:

• 
  Age Group: 18+ years
  
• 
  Gender: Both male and female
  
• 
  Fractures of proximal tibia with or without intra articular extension and with or without extension to middle third.
  
• 
  Patients who are willing to undergo surgery
  

Exclusion criteria :

• 
  Children and adolescents below 18 years
  
• 
  Compound fractures (Gustilo Anderson classification)
  
• 
  Patients who are not surgically fit
  
• 
  Patients who are not willing for surgery
  

3. 
   Does the study require any investigations or interventions t0 be conductedon patients or human or animals? If so please describe briefly
   

Yes

1. 
   Complete blood count
   
2. 
   Random blood sugar
   
3. 
   Blood urea and Serum creatinine
   
4. 
   ECG
   
5. 
   BT,CT,aPTT
   
6. 
   X-Rays : knee with tibia full lenth AP and Lateral views
   
7. 
   Blood grouping and typing
   

3. 
   Ethical clearence been obtained from your institution in case of 7.3?
   

Yes

7. 
   LIST OF REFERENCES:
   

1. 
   Collinge C, Sanders R. Minimally-invasive plating .J Amer Acad Orthop Surg .2000;8:211-217
   
2. 
   Collinge C, Sanders R,DiPasquale T. Treatment of complex tibial periarticular fractures using percutaneous techniques . Clin Orthop Relat Res.2000;375:69-77
   
3. 
   Helfet DL, Shonnard PY, Levine D, et al. Minimally Invasive plate osteosynthesis of distal fractures of the tibia. Injury. 1999;28:S-A42- S-A48.
   
4. 
   S. Terry Canale, James H. Beaty. Campbell’s Operative Orthopaedics 12^th ed. (vol 3) Philadelphia: Elsevier Mosby; 2013.
   
5. 
   De Coster TA, Nepola JV, Choury GY. Treatment of proximal tibia fracture. A ten year follow up study. Clin Orthop Relat Res 1994;196-204
   
6. 
   Sirkin MS, Bono CM, Reilly MC and Behrens FF. Percutaneous methods of tibial plateau fixation. Clin Orthop 2000 June; 375:60-68.
   
7. 
   Palmer I. Compression fracture of lateral tibial condyle and their treatment. J Bone & Joint Surg 1939;2(AM):674.
   
8. 
   Duparc, Ficat. Fracture of the tibial plateau in Insall et al surgery of the knee. 2nd edn, Vol 2. New York, Churchill Livingstone; 1994. p. 1074.
   
9. 
   Roberts JM. Fractures of the condyles of tibia, an anatomical and clinical end result study of 100 cases. J Bone & Joint Surg 1968;50(AM):1505.
   
10. 
    Schatzkar J, McBroom R, Bruce D. The tibial plateau fractures. Toronto Experience. Clin Orthop 1979;138:94.
    
11. 
    Burri G, Bartzke J, Coldewey J, Mugglar E. Fracture of the tibial plateau. Clin Orthop 1979;138:64.
    
12. 
    Lansinger O, Burgman B, Korner L. Tibial condylar fracture. 20 years followup. J Bone & Joint Surg 1986;68(AM):13-19.
    

13. 
    Gonzailez HY, Mortan, Sainchez JF, Erasun RC. Early results with the new internal fixator system LCP and LISS : Prospective study. Acta Orthop Belg 2007;73(1):64.
    

14. 
    Ring D, Kloen P, Kadizielski J, Halfet D, Jupiter JB. Locking compression plates for the osteoporotic nonunions of the diaphyseal humerus. Clin Orthop Relat Res 2004 Aug;425:50-4
    

15. 
    Krupp RJ, MalkaniAL, Roberts CS,Seligson D,Craford CH,Smith LBS.Treatment of Bicondylar Tibia Plateau Fractures Using locked Plating Versus External Fixation.Orthop 2009 Aug.;32(8):559.
    

16. 
    Sumit Arora et al. salvage og proximal tibial fracture treated with locked compression plate. J. clin orthop & trauma- June 2012  (Vol. 3, Issue 1, Pages 58-61, DOI: 10.1016/j.jcot.2011.10.001)
    

17. 
    Tantray, Mehraj Din et al. A clinical study for management of tibial diaphyseal fractures in adults with LCP using MIPPO technique. Internet Journal of Orthopedic Surgery;2011, Vol. 18 Issue 2, p1
    

Signature of the Candidate:
Remarks of the Guide:	Fractures of the proximal tibia which are not suitable for interlocking nailing need fixation which is to be more biological. Minimally invasive plate osteosynthesis is a better option available to conventional open reduction and internal fixation as it preserves the soft tissue and fracture hematoma.
Name and designation of the Guide: (In Block Letters)	Dr D M NAGABHUSHANA, MS(ORTHO) PROFESSOR OF ORTHOPAEDICS, JJMMC, DAVANGERE. 577004
11.1 Signature of the Guide:
11.2 Co-Guide (If any):
11.5 Head of Department:	Dr. T M RAVINATH D(ORTHO), MS(ORTHO) PROFESSOR AND HEAD OF DEPT OF ORTHOPAEDICS JJMMC, DAVANGERE. 577004
11.6 Signature of HOD:
Remarks of the HOD:
12.1 Name of the principal:	DR. MANJUNATH ALUR, MD PRINCIPAL AND PROFESSOR OF GENERAL MEDICINE, JJMMC, DAVANGERE - 577004
12.2 signature of the principal: