Rajiv Gandhi University of Health Sciences, Bangalore, Karnataka s54

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA,

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DESSERTATION

6. BRIEF RESUME OF THE INTENDED WORK:

6.1 NEED FOR THE STUDY:

6.2 REVIEW OF LITERATURE:

Among the earlier writings, one often reads statements such as, “In persons over Sixty years of age who fall and cannot rise, the reason will be found to be fracture of the neck of the femur” (Allis). The same author also states “Bony union cannot be hoped for”.

The anatomic construction of the neck of the femur differs from that

Found in any other place in the body. The neck and shaft- join at an oblique angle. Stress of weight bearing, of course, brings strain on the femoral neck in a plane which is not parallel with its longitudinal axis. Decrease in the tensile strength of the neck, such as must be expected in advancing years, and renders this bone more prone to fracture than a long bone of the same strength in which the force is exerted parallel to the longitudinal axis.

The fall followed by disability, pain, eversion (external rotation) of the foot and shortening of the leg, with spasm of the muscles around the hip is common presentation.2)

Common classification utilized is Gardens Classification-

The Garden classification of femoral neck fractures 3

Garden stage I- the fracture is incomplete, with the head tilted in a posterolateral direction. Practically speaking, this is an impacted fracture.

Garden stage II -fractures are complete, but undisplaced.

Garden stage III- fractures are complete and partially displaced, as judged by the direction of the trabecular stream in the head fragment, but the two fragments remain in contact with each other.

Garden stage IV- fractures, the fragments are completely displaced, and the trabeculae of the femoral head realign themselves with the trabeculae within the acetabulum.

Different methods used for the treatment of femoral neck fracture depending on the type of fracture and age of the patient are-

a. Osteosynthesis:

In osteosynthesis, anatomical reduction and rigid internal fixation, with or without vascularised grafting is done in younger age group.

b. Osteotomy:

Done in ununited fracture of the femoral neck in younger age.. The following procedures are done: a) Mc Murray’s Osteotomy,b) Dickson’s Osteotomy & c) Pauwel’s Y-Osteotomy

c. Hemiarthroplasty of Hip:

It is dissatisfaction of many surgeons with the above methods of treatment particularly in older people that lead to trail of hip prosthesis as a final procedure in reestablishing a painless, functional and stable hip, thereby escaping the uncertainty of bony union and late onset of osteoarthritis.

Many studies were done to compare the advantages and disadvantages of unipolar and bipolar. The following were observed.

S. J. CALDER observed that outcome of a unipolar prosthesis may give better short-term results in octogenarians. Whether this is sustained in the long term or offset by a higher rate of revision will become clear in the future. It may be that younger patients (65 to 79 years) who are more mobile would benefit more from a bipolar implant but longer follow-up is needed to

Assess the results. We see no justification for the use of the expensive bipolar hip prosthesis in patients over 80 years of age, regardless of their mental state or mobility.4

R.Marcur,J.Heintz concluded that final outcome of bipolar hemiarthroplasty were not significantly better than those of the press fit Austin moore prosthesis in the treatment of acute displaced femoral neck fractures in elderly patients.the medical complication rate was similar, however , there was a significant drop in the dislocation rate with a bipolar prosthesis.5

ROCKWOOD & GREEN says that Austin-Moore arthroplasty, historically, has functioned as a good component over the years, and there are many case reports of these actually lasting a long of time (>20 years). Its main advantages in the past were its reduced cost and relatively reduced operative time. Its disadvantages were the relatively poor outcomes in active patients secondary to poor femoral fixation and a marked potential for acetabular erosion. Therefore, at this time, the indication for a Moore's arthroplasty should be reserved for very limited or nonambulatory, low-demand patients’.Also observed a high rate of implant loosening compared to the bipolar.6

Cornell CN based on his study observed that there is no differences in the postoperative complication rates or lengths of hospitalization were seen between the two groups. Patients treated with a bipolar hemiarthroplasty had greater range of hip motion in rotation and abduction and had faster walking speeds. However, no differences in hip rating outcomes were found. These early results suggest that use of the less expensive unipolar prosthesis for hemiarthroplasty after femoral neck fracture may be justified in the elderly.7

Based on the results of this study by Koval, Kenneth J 8 there does not appear to be any advantage to the use of a bipolar endoprosthesis compared to the Austin Moores in the management of displaced femoral neck fractures in the elderly. Furthermore, the extra cost of bipolar endoprostheses does not seem to warrant its use.

Parker MJ searched the Cochrane Bone, Joint and Muscle Trauma Group Specialized Register (September 2009), CENTRAL (The Cochrane Library 2009, Issue 3), MEDLINE, EMBASE and trial registers (all to September 2009), and reference lists of articles, from the trials to date there is no evidence of any difference in outcome between bipolar and unipolar prosthesis. There is some evidence that a total hip replacement leads to better functional outcome than a hemiarthroplasty. Further well-conducted randomized trials are required.9

Chapman CB based on this study found that there were no differences between the groups (Unipolar And Bipolar) in estimated blood loss, length of hospital stay, mortality rate, and number of dislocations, postoperative complications, or ambulatory status at 1 year. There also were no significant differences between the two groups at either point in postoperative Short Form-36 or Musculoskeletal Functional Assessment instrument scores. Results of this prospective randomized study suggest that the bipolar endoprosthesis provides no advantage in the treatment of displaced femoral neck fractures in elderly patients regarding quality of life and functional outcomes 10

6.3 AIMS AND OBJECTIVES

Aim-

Comparative study in the management of fracture neck femur using Bipolar and Austin moore prosthesis.

Objectives- It is compared based on following factors

·  To assess the quality of life after Hemiarthroplasty with Austin moores and bipolar prosthesis

·  To find out the number of days hospital stay between the two prosthesis

·  To compare the recovery of physical, social and vocational independence and rehabilitation among Austin Moore and bipolar prosthesis

·  To compare the radiographic changes after Hemiarthroplasty among Austin Moore and bipolar prosthesis

·  To compare the complications with the procedure, which include painful hip, stem loosening, infections, acetabular erosions, prosthetic migrations,dislocation, ROM & prosthetic removal between the two prosthesis

·  To compare the movements of prosthesis under C arm image among the two prosthesis

7. MATERIAL AND METHODS:

7.1 SOURCE OF DATA: Fracture neck of femur is mostly commonly encountered fractures in an elderly. This is a comparative study on 40 cases regarding the management using bipolar prosthesis and an Austin moores prosthesis, its advantages, disadvantages, prognosis and complications.

a)STUDY PLACE: Both in-patients and out-patients Cases in Dept. of Orthopaedics and Casualty in KIMS Hospital and Research Centre, Bangalore

b) DURATION OF STUDY: one and half year. Cases will be followed up at 6 weeks, 12 weeks and 24 weeks following surgery.

c) STUDY DESIGN: Prospective study

d) SAMPLE DESIGNING – Purposive sampling

e) SAMPLE SIZE: 40 cases (20 cases in each group)

7.2 METHOD OF COLLECTION OF DATA:

a) Patient data collection and evaluation.

Patient who meet the inclusion and exclusion criteria will be selected from all patients attending KIMS orthopedics OPD & Casualty department will be admitted.

The patients will be evaluated and followed up according to protocol.

Detailed history of patient will be entered in Proforma

·  Complete haemogram

·  X ray Pelvis with both hip –AP view in internal rotation and lateral view

·  X ray chest PA view

·  Patient will be put on Bucks traction if necessary

·  Patient will be informed about the surgical procedure and consent would be taken.

·  Patient will also be informed about this study

·  Physicians fitness for the surgery will be obtained

·  Under appropriate anesthesia ,Surgical procedure with either bipolar or Austin moores prosthesis is done

·  Patient is mobilized on 3rd day with walker support.

·  Follow up of patients at 6 weeks,12 weeks and 24 weeks following surgery and analyzed with the help of Harris Hip Score.

Data collection:

FOLLOWUP OF PATIENTS:

Cases will be followed up at 6 weeks,12 weeks and 24 weeks following surgery and earlier in case any complications.

7.3  INCLUSION CRITERIA:

·  Cases of fracture neck Femur of Age group above 60 years.

·  All patients medically fit for surgery even with hypertension and diabetes mellitus

·  All types of fractures under Gardens Classification are considered

·  Closed Fracture

·  Fracture within 3 weeks

7.4  EXCLUSION CRITERIA:

·  Seriously ill patients & Pts not fit for surgery.

·  Fracture due to tumour or any other pathological cause.

·  Compound Fractures

·  Other limb fractures and diseases

·  Neurovascular injuries

7.5  STATISTICAL ANALYSIS

·  Data collected in the study will be analysed using Descriptive statistics like mean, standard deviation and percentage and inferential statistics like Chi-Square test and student-t test.

·  The results will considered statistically significant whenever p≤0.05

7.6 DOES THE STUDY REQUIRED ANY INVESTIGATIONS

OR INTERVENTIONS TO BE CONDUCTED ON PATIENTS?

IF SO PLEASE DESCRIBE BRIEFLY:

·  Complete haemogram

·  X ray Pelvis with both hip –AP view in internal rotation and lateral view

·  X ray chest PA view

·  Patient will be put on Bucks traction if necessary

·  Surgical procedure with either bipolar or Austin moores prosthesis

·  Follow up x rays at post-operative, 6 weeks, 12 weeks and 24 weeks following surgery and c-arm images to check the movement of the prosthesis

7.7 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION, IN CASE OF 7.6?

Yes

8.LIST OF REFERENCES:

1-UNDP 2002- human development report 2002, deepning democracy in a fragmented world, oxford university press

2- JOHN C. WILSON .FRACTURE OF THE NECK OF THE FEMUR. J Bone Joint Surg Am. 1924;6:876-884

3. Campbell’s Opeative Orthopaedics 11th edition. Hip Fractues.2007 edition. 3274

4- S. J. CALDER, G. H. ANDERSON, C. AGGER, W. M. HARPER, P. J. GREGG.UNIPOLAR OR BIPOLAR PROSTHESIS FOR DISPLACED INTRACAPSULAR HIP FRACTURE IN OCTOGENARIANS. J Bone Joint Surg Br. 1996 May;78(3):391- 4

5-R.MARCUS,J.HEINTZ AND A.PATTEE. Comparison of the Austin-Moore and Bipolar Hemiarthroplasty in the Treatment of Femoral Neck Fractures. Journal of Orthopaedic Trauma: June 1989 ;3(2); 173

6-ROCKWOOD & GREEN'S FRACTURE IN ADULTS & CHILDREN - 6TH EDITION.FEMORAL NECK FRACTURE.2009 edition. 1591-92

7- Cornell CN, Levine D, O'Doherty J, Lyden J. Unipolar versus bipolar hemiarthroplasty for the treatment of femoral neck fractures in the elderly. Clin Orthop Relat Res. 1998 Mar;(348):67-71.

8- Ong, Bernard C; Maurer, Stephen G; Aharonoff, Gina B.; Zuckerman, Joseph D.; Koval, Kenneth J . Unipolar versus Bipolar Hemiarthroplasty: Functional Outcome After Femoral Neck Fracture at a Minimum of Thirty-six Months of Follow-up.Journal of Orthopaedic Trauma: May 2002 ;16(5) ;317-322.

9-Parker MJ, Gurusamy KS, Azegami S. Arthroplasties (with and without bone cement) for proximal femoral fractures in adults. Cochrane Database Syst Rev. 2010 Jun 16;(6):CD001706.

10- Raia FJ, Chapman CB, Herrera MF, Schweppe MW, Michelsen CB, Rosenwasser MP. Unipolar or bipolar hemiarthroplasty for femoral neck fractures in the elderly?. Clin Orthop Relat Res. 2003 Sep;(414):259-65.

9. SIGNATURE OF THE CANDIDATE:

10. REMARKS OF THE GUIDE:

Hemiarthroplasty is worldwide well documented study using Bipolar and Austin moore prosthesis. This study is to evaluate and compare the outcomes of Bipolar Vs Austin moore prosthesis.

11. NAME AND DESIGNATION OF THE GUIDE

DR.SOMASHEKAR,

DEPARTMENT OF ORTHOPAEDICS,

KIMS, BANGALORE

SIGNATURE OF THE GUIDE:

12.HEAD OF THE DEPARTMENT-

PROFESSOR. J. N. SRIDHARA MURTHY,

DEPARTMENT OF ORTHOPAEDICS,

KIMS, BANGALORE

12.1 SIGNATURE:

13. CHAIRMAN AND PRINCIPAL: