RAJIVGHANDHIUNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA

ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECT FOR

DISSERTATION

1. / Name of the candidate and address / Dr. ANNAPPA SWAMY. B.S.
NO. B108, KPWD QUATRESS, JEEVAN BHEEMA NAGAR, BANGALORE.
2. / Name of the institution / BANGALOREMEDICALCOLLEGE AND RESEARCH INSTITUTE, BANGALORE
560002.
3. / Course of study and subject / M.S. IN ORTHOPEDICS
4. / Date of admission to course / 13.09.2011
5. / Title of the topic / “A PROSPECTIVE STUDY OF PHARMACOLOGICAL PROPHYLAXIS OFDEEP VENOUS THROMBOSIS IN ARTHROPLASTY”
6 / Brief Resume of Intended Work:
6.1 Need for Study:
Thromboembolic disease is the most common serious complication arising from total hip arthroplasty. It is the most common cause of death occurring within three months of surgery and is responsible for more than 50% of the post operative mortality after total hip arthroplasty. Deep vein thrombosis also can lead to postphlebitic syndrome in the lower extremities. Without prophylaxis, venous thrombosis occurs after total hip replacement in as many as 40 to 70% of patients, and fatal pulmonary emboli occur in approximately 2%. The mortality rate of emboli in total hip arthroplasty patients who do not receive prophylactic medication is reported to be five times greater than that for abdominal and thoracic surgery in patients in the same age group.[1]
Most deaths from acute pulmonary embolism with in 30 minutes of the embolic event. For these patients, available time is insufficient to recognise, diagnosis and begin therapy in order to alter the course of events. Therefore in patients at high risk for Deep Venous Thrombosis, prophylaxis is paramount. [2]
The incidence of Deep Venous Thrombosisafter total hip arthroplasty and total knee arthroplasty 9.1% and 4.0% respectively and the incidence of pulmonary embolism were 3.0% and 0% respectively. [3]
Incidence of Deep Venous Thrombosisor PulmonaryEmbolism are still seen in spite of prophylaxis hence to find out the efficacy of the pharmacological prophylaxis against Deep Venous Thrombosisor Pulmonary Embolism has promoted us to under take this study.
6.2 Review of Literature:
PL Chin, etal. Concluded, in Western population the prevalence of DVT (Deep Venous Thrombosis) after total knee Arthroplasty has been reported to be 46 to84%. In Asian population it is lower. But recently has been increasing. This difference may be due to a lack of prothrombotic clotting factor polymorphisms ( factor V leiden and prothrombin G20210A) among the Asians.[4]
Nail P Sheth etal on (DVT prophylaxis in Total Joint Reconstruction showed ) patients undergoing primary total hip Arthroplasty or TKR (Total Knee Replacement ) have exhibited rates of SymptomaticPE (Pulmonary Embolism) as high as 20% and 8% respectively, when no prophylaxis has been administered. As a result the use of venous thrombo embolic (DVT- Deep Venous Thrombosis and PE - Pulmonary Embolism) prophylaxis most commonlyundergoing elective TJA (Total Joint Arthroplasty). The risk of fatal PE (Pulmonary Embolism) following primary hip or knee replacement has been consistently reported to be between 0.1% & 0.2%.[5]
Philip C Comp etal, the authors evaluated the efficacy and safety of a prolonged post hospital regimen of enoxaparin following elective THR (Total Hip Replacement ) or TKR (Total Knee Replacement ), 968 patients received subcutaneous enoxaparin for 7 to 10 days and 873 were then randomized to receive, three weeks of double –blind out patient treatment with either enoxaparin (40mg one a daily) or a placebo, enoxaparin was superior to the placebo in reducing the prevalence of Venous thrombo embolism in patient treated with THR (Total Hip Replacement ) 17.5% of the patients treated with exoxaparin had DVT (Deep Venous Thrombosis ) compared with 4620.8% of patient treated placebo.
Symptomatic PE (Pulmonary Embolism) developed in three patients. One with a hip replacement and two with a knee replacement. All had received the placebo.[6]
Salvati etal, the author point out that timing of heparin administration may be critical for DVT (Deep Venous Thrombosis ) Prophylaxin. They point out that thrombogenesis begins during preparation of the femur and is most pronounced with implantation of femoral components with cement rather than with out cement, the authors recommend giving a bolus of 1V heparin (approximately 3000 units) just before cement preparation of the femur following Seven days.[7]
A Sudo etal in his study the Patients were routinely examined for proximal deep vein thrombosis by B-mode ultrasonography before and after surgery. Those patients who had ultrasonographic findings of deep vein thrombosis were also investigated for pulmonary embolism by ventilation-perfusion lung scan. Results. The incidence of deep vein thrombosis after total hip arthroplasty and total knee arthroplasty were 9.1% and 4.0% respectively, and the incidence of pulmonary embolism were 3.0% and 0%, respectively. There were no cases of fatal pulmonary embolism.
In order to clarify the incidence of DVT (Deep Venous Thrombosis ) and PE (Pulmonary Embolism) in Japan, we prospectively studied consecutive patients before and after THA (Total Hip Arthroplasty ) and TKA (Total Knee Arthroplasty ). B-mode ultrasonography was used for detecting major proximal thrombi, for which there was a risk of detachment from the venous wall, proximal migration and subsequent fatal PE(Pulmonary Embolism).
None of the patients had DVT (Deep Venous Thrombosis ) prior to surgery. Four patients had a postoperative DVT (Deep Venous Thrombosis ) detected by ultrasonography, and confirmed by venography (Table 2). There was one case of non-fatal PE (Pulmonary Embolism) among these 4 cases. The incidence of DVT (Deep Venous Thrombosis ) was 9.1% in patients following THA (Total Hip Arthroplasty) and 4.0% following TKA (Total Knee Arthroplasty ), while that of PE (Pulmonary Embolism) was 3.0% following THA (Total Hip Arthroplasty ) and 0% following TKA (Total Knee Arthroplasty). The incidence was 6.4% in patients undergoing primary surgery, and 9.1% in those having revision surgery.[8]
R. Gandhi, etal in their study showed unilateral TKR(Total Knee Replacement) between 1998–2006. Demographic variables of age, sex, comorbidity, and education were retrieved. Metabolic syndrome was defined as body mass index above 30 kg/m2, diabetes, hypertension, and hypercholesterolemia.
The overall incidence of symptomatic DVT (Deep Venous Thrombosis) was 4.4% (65/1460). Patients with metabolic syndrome had an increased incidence of DVT(Deep Venous Thrombosis) compared to those without metabolic syndrome (15.5% vs 3.4%).
Hospital protocols developed for prophylactic anticoagulation following TKR(Total Knee Replacement ) should give special consideration to patients with metabolic syndrome.[9]
S Nathan, etal in their study revealed the incidence of deep vein thrombosis (DVT) following total knee arthroplasty in an Asian population. A prospective study of 149 consecutive cases of total knee arthroplasty done for osteoarthritis was conducted over a 5-year period. All patients underwent duplex ultrasonographic assessment of the lower limbs within the first postoperative week. The incidence of proximal DVT (Deep Venous Thrombosis ) was found to be 4.38% in this study. Symptomology was statistically significant in predicting the presence of proximal DVT(Deep Venous Thrombosis ) in all cases. General anesthesia was associated with a statistically significant–higher incidence of DVT(Deep Venous Thrombosis ) as compared with regional anesthesia. DVT (Deep Venous Thrombosis ) was found in 9 out of the 148 Asian patients (the Caucasian patient excluded) in this study, yielding an overall incidence of 6.08%. Duplex ultrasonography was the preferred means of diagnosis in this study. Venography remains the most reliable and accurate modality to detect DVT (Deep Venous Thrombosis ), and is regarded as the index method.[10]
6.3 Aims and Objectives:
  1. To find out the efficacy of Pharmacological Prophylaxis against DVT(Deep Venous Thrombosis ) or PE(Pulmonary Embolism)
  2. To find out incidence of DVT (Deep Venous Thrombosis) or PE (Pulmonary Embolism) Despite prophylaxis.
  3. To formulate Hospital protocol for DVT(Deep Venous Thrombosis) Prophylaxis.

7. / MATERIALS AND METHODS :
7.1 Source of Data:
Adult patient of eithersex admitted and willing for Arthroplasty in Victoria and Bowring & Lady Curzon hospital attached to Bangalore Medical College & Research Institute.
7.2 Method of Collection of Data:
  1. Study Design : Prospective Study.
  1. Study Period : November 2011 to October 2012.
  1. Sample Size : A minimum of 50 cases will be taken up for the study.
  1. Inclusion Criteria:
1. All patient undergoing for THR(Total Hip Replacement ), TKR(Total Knee Replacement )HRA(Hemi Replacement Arthroplasty) in our Institution
2. Written informed consent for investigation and surgery.
  1. Exclusion Criteria:
Patients who have got Pre-operative DVT(Deep Venous Thrombosis).
  1. Methodology and type of Data Collection:
After obtaining clearance and approval from the institutional ethical committee and patients fulfilling the inclusion / exclusion criteria will be included in the study after obtaining the informed consent. History Taking, Clinical Examination, Investigations like Blood Examination & Doppler Study. Patients follow up will be recorded - 2nd day, 4th day, 1stweek, 2ndweek, 4thweek & 6thweek.
  1. Assessment tools :
  • Proforma for informed consent.
  • Vital Signs:
Pulse rate (Pulsations / minute)
Blood Pressure
Temperature.
  • A through history / physical examination will be carried out and recorded in the protocol.
-Calf muscle and thigh muscle tenderness.
-Homan’s and Moose’s signs.
  • Relevant laboratory investigations.
-Blood Biochemistry- Random Blood Glucose, Clotting Time and Bleeding time, Prothrombine time, Blood urea and Serum creatinine
-Blood counts including platelets.
-Doppler Study.
-Electrocardiogram.
  1. Statistical Analysis: Chi Square 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.
The patients will be subjected to the following relevant investigations:
-Haemogram
-Bleeding Time, Clotting Time, Prothrombine Time.
-Blood Grouping and Cross matching.
-Random Blood Sugar, Urea, Serum Creatinine.
-Doppler Study.
7.4 Has the ethical clearance been obtained from your institution in case of 7.3?
8.0 / List of References :
  1. James W.Harkess. Arthroplasty ofHip. Canale ST, Beaty JH,Campbell's OperativeOrthopaedics.Elsevier Inc.. 10thEdn. Vol. I. 2003; Ch 7: 407-410.
  1. John A.Heit. Thrombophlebitis. Morrey B.F. Reconstructive Surgery of the joints. 2nd Edn. Vol. -1. 1996; Ch. 19: 171-182.
  1. A Sudo, et al Japan. “The incidence of deep vein thrombosis after hip and knee arthroplasties in Japanese patients: A prospective study”. Journal of Orthopaedic Surgery: 2003; 11(2): 174–177
  1. PL Chin, MS Amin, KY Yang, etal. - thrombembotic prophylaxes for total knee arthoplasty in Asian patients, randomised controlled trials: Journal of Orthopaedic Surgeon: 2009; 17 : 1-5.
  1. Nail P Sheth, Jay R. Lieberman, Craig J. et al. - DVT prophylaxis in total joint reconstruction of ortho clinic; Am 41 (2010); 273-280.
  1. Philip C. Comp. et al. DVT/PE Prophylaxis in THR, Original Text by Clifford R. Wheeless. III MD; Last updated by Data Trace Staff on Thursday, September 8, 2011.
  1. Salvati. et al. DVT/PE Prophylaxis in THR. Original Text by Clifford R. Wheeless, III, MD;.Last updated by Data Trace Staff on Thursday, September 8, 2011.
  1. A Sudo, et al Japan. “The incidence of deep vein thrombosis after hip and knee arthroplasties in Japanese patients: A prospective study”. Journal of Orthopaedic Surgery: 2003; 11(2); 174–177.
  1. R. Gandhi, Fahad Razak, Peggy Tso. et al. Toronto Western Hospital, Canada. “Metabolic Syndrome and the Incidence of Symptomatic Deep Vein Thrombosis Following Total Knee Arthroplasty.” unilateral TKR between 1998–2006:
  1. S Nathan, Md A Aleem, P Thiagarajan. et al. “The incidence of proximal deep vein thrombosis following total knee arthroplasty in an Asian population: A Doppler ultrasound study”; Journalof Orthopaedic Surgery 2003; 11(2): 184–189.

9.0 / Signature of the Candidate : / (Dr. ANNAPPA SWAMY. B.S.)
10.0 / Remarks of the Guide : / This study can evaluate the incidence of DVT(Deep Venous Thrombosis) in arthroplasty patients and efficacy of anticoagulants in preventing / treating DVT(Deep Venous Thrombosis). The inference can be used to device guidelines of management of DVT(Deep Venous Thrombosis) in artroplasty patients in our hospital.
11.0 / Name and Designation :
11.1 Guide:
11.2 Signature:
11.3 Co-Guide (if any):
11.4 Signature
11.5 Head of the Department
11.6 Signature: / Dr. MANJUNATH. K.S.
MBBS, D’Ortho, DNB (Ortho),
Professor and Head of the Department of Orthopedics,
BangaloreMedicalCollege and Research Institute,
Bangalore – 02.
None
Not Applicable
Dr. MANJUNATH. K.S.
MBBS, D’Ortho, DNB (Ortho),
Professor and Head of the Department of Orthopedics,
BangaloreMedicalCollege and Research Institute, Bangalore. – 02.
12.0 / DEAN & DIRECTOR :
12.1 Remarks of the Dean & director :
12.2 Signatureof Dean & director : / Dr. O.S. SIDDAPPA,
MBBS, MS, Mch.
Dean & Director,
BangaloreMedicalCollege and Research Institute,
Bangalore. – 02
ANNEXURE 1
I, Mr/Mrs/Ms______, exercising my own free will power of choice, hereby give consent for myself as an object in “A PROSPECTIVE STUDY OF PHARMACOLOGICAL PROPHYLAXIS OF DEEP VENOUS THROMBOSIS IN ARTHROPLASTY”conducted by Dr. Manjunath. K.S., Professor and Head of the Department of Orthopedics and Dr. Annappa Swamy. B.S., Post Graduation Student, BangaloreMedicalCollege and Research Institute, Bangalore.
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: Signature/Left thumb impression of the patient
DATE:
Signature of the witness:
DATE: