Rajiv Gandhi University of Health Sciences, Bangalore, Karnataka s29

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE, KARNATAKA

SYNOPSIS

OF

DISSERTATION

"STUDY OF FUNCTIONAL OUTCOME OF

SURGICAL MANAGEMENT OF PROXIMAL

HUMERUS FRACTURE

BY VARIOUS MODALITIES"

Submitted by

DR. ROHIT JAGANNATH NALAWADE

M.B.B.S.

POST GRADUATE IN ORTHOPAEDICS

DEPARTMENT OF ORTHOPAEDICS

ADICHUNCHANAGIRI INSTITUTE OF MEDICAL SCIENCES,

B.G.NAGARA-571448

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1 / NAME OF THE CANDIDATE
AND ADDRESS
(in block letters) / DR ROHIT JAGANNATH NALAWADE,
P.G. IN ORTHOPAEDICS,
ADICHUNCHANAGIRI INSTITUTE OF
MEDICAL SCIENCES, B.G. NAGARA,
MANDYA DISTRICT -571448
2. / NAME OF THE INSTITUTION /

ADICHUNCHANAGIRI INSTITUTE OF

MEDICAL SCIENCES, B.G.NAGARA.
3. / COURSE OF STUDY AND SUBJECT /

M.S. IN ORTHOPAEDICS

4. / DATE OF ADMISSION TO COURSE / 31ST MAY 2010
5. / TITLE OF THE TOPIC / “STUDY OF FUNCTIONAL OUTCOME OF SURGICAL MANAGEMENT OF PROXIMAL HUMERUS FRACTURE BY VARIOUS MODALITIES”
6. / BRIEF RESUME OF INTENDED WORK
6.1  NEED FOR THE STUDY
6.2 REVIEW OF LITERATURE
6.3 OBJECTIVES OF THE STUDY / APPENDIX-I
APPENDIX-IA
APPENDIX-IB
APPENDIX-IC
7 / MATERIALS AND METHODS
7.1  SOURCE OF DATA
7.2 METHOD OF COLLECTION OF DATA : (INCLUDING SAMPLING PROCEDURE IF ANY)
7.3 DOES THE STUDY REQUIRE ANY INVESTIGATION OR INTERVENTIONS TO BE CONDUCTED ON PATIENTS OR OTHER ANIMALS, IF SO PLEASE DESCRIBE BRIEFLY.
7.4 HAS ETHICAL CLEARENCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.3 / APPENDIX-II
APPENDIX-IIA
APPENDIX-IIB
YES
APPENDIX-IIC

YES

APPENDIX-IID
8. / LIST OF REFERENCES /

APPENDIX - III

9. / SIGNATURE OF THE CANDIDATE /
10. /

REMARKS OF THE GUIDE

/ THIS STUDY LEADS US TO CHOOSE AMONG THE AVAILABLE APPROACHES FOR BEST RESULTS
11 / NAME AND DESIGNATION
(in Block Letters)
11.1 GUIDE / DR. MANJAPPA. C.N.,
M.B.B.S., M.S ORTHO.,
ASSOCIATE PROFESSOR,
DEPARTMENT OF ORTHOPAEDICS,
A.I.M.S., B.G.NAGARA-571448.
11.2 SIGNATURE OF THE GUIDE
11.3 CO-GUIDE (IF ANY)
11.4 SIGNATURE
11.5 HEAD OF DEPARTMENT / DR. GUNNAIAH.,
M.B.B.S., D.ORTHO, M.S. ORTHO.,
PROFESSOR AND HEAD,
DEPARTMENT OF ORTHOPAEDICS,
A.I.M.S., B.G.NAGARA-571448.
11.6 SIGNATURE
12 / 12.1 REMARKS OF THE CHAIRMAN
AND PRINCIPAL / The facilities required for the investigation will be made available by the college
Prof. Dr. VASANTH KUMAR. S.B
M.Sc, M.B.B.S., MS, FICS, FIAGES
PRINCIPAL,
A.I.M.S., B.G.NAGARA-571448.
12.2 SIGNATURE

APPENDIX-I

6.BRIEF RESUME OF THE INTENDED WORK:

APPENDIX –I A

6.1 NEED FOR THE STUDY:

Proximal humeral fractures account for almost 4 to 5% of all fractures. These fractures have a dual age distribution occurring either in young people following high energy trauma or in those older than 50 years with low velocity injuries like simple fall. Most of the proximal humeral fractures are non-displaced or minimally displaced and stable. These can be treated non-operatively successfully with early rehabilitation. But severely displaced and comminuted fractures warrant surgical management for optimum shoulder function.

Treatment of unstable displaced fractures of the proximal humerus has remained controversial. Various surgical treatment modalities for displaced proximal humeral fractures are pins, wires, heavy sutures, staples, rush nails, screws and plates, hemiarthroplasty, intramedullary nailing, retrograde nails and pins, external fixationand tension band wiring.

All these techniques have been associated with various complications including implant failure, loss of reduction, nonunion or malunion of the fracture, impingement syndrome, and osteonecrosis of the humeral head.

However till now very limited prospective studies have been done describing the functional outcome and complications following surgery of the proximal humeral fractures by different modalities. Therefore, the present study will be carried out to assess and evaluate the surgical outcome of the proximal humeral fractures by different modalities.

APPENDIX –I B

6.2 REVIEW OF LITERATURE

Ancient physicians advocated bandaging and rest for closed proximal humerus fractures, while open fractures were usually fatal. In medieval Europe, aobonesetters performed some manipulations and operations, but little detail of these treatment methods is available in written documentation .1

In the past century, nonoperative treatment of proximal humerus fractures has been documented as an acceptable approach. Treatment modalities have included traction, manipulation, and casting, with an emphasis on early functional range of motion. It has generally been considered that results could be good even with malunion. However, some surgeons did recognize that significant displacement, especially in comminuted proximal humerus fractures, was associated with a poor functional outcome.

The first systematic approach to surgical fixation of proximal humerus fractures was described by Lambotte in Belgium and Lane in Great Britain. Subsequently, other surgeons described many methods of surgical repair and fixation of proximal humerus fractures, including staples, plates and screws, blade plates, intramedullary (IM) nails, retrograde nails and pins, external fixation, and tension-band fixation.1

In 1970 the AO Group published its Manual of Internal Fixation, the first practical guide to fracture fixation using combinations of plates and screws. The concept of minimal fixation to preserve the blood supply to the head and the anterolateral artery was first described by Neer. This set the stage for an ongoing controversy between proponents of rigid fixation of fractures and those advocating minimal fixation. This controversy is discussed further in this chapter as it pertains to current approaches in the treatment of specific fracture types.1

Biomechanical studies have shown that intramedullary proximal humerus nails are superior to conventional plating in terms of implant stiffness, resistance to deformation, and failure.3Additionally, development of angular stable antegrade nails for proximal humeral fractures promise to offer high stability in osteoporotic bone ensuring early mobilization and favorable clinical results.2,3,4

In 2005 Vimal kumar reported that 83% of the patients who had proximal humerus fractures had excellent and good functional outcome graded according to the criteria of Neer, after closed reduction and percutaneous pinning. 2 part fracture yields good results when treated by this procedure. The 19% fair/poor result in 3 part fractures were due to improper patient selection. Functional outcome was poor for patients more than 60 years and this should be considered in patient selection with communition and bone quality.

In 2004, In a larger retrospective study Bjorkenheim et al5examined 72 patients (mean age 67 years) with the proximal locking plate 38 two-part, 22 three-part, and 12 four-part fractures. After 12 month follow-up no cases of subacromial impingement, 2 nonunions, 3 cases of avascular humeral head necrosis, and 2 hardware failures that were ascribed to technical errors were observed, totaling a 9.7% complication rate.

Additionally 26% healed in slight varus malalignment. Despite this, the mean Constant score of 73 points was similar to the aforementioned studies.5

In 2007,Maintenance of reduction and prevention of secondary dislocation into varus in proximal humeral fractures with medial comminution seems to be challenging for angular stable plates. A recent study from Gardner et al6specifically looked at medial support in maintaining fracture reduction after fixation with an angular stable plate. They found a significantly increased loss of humeral head height in cases without medial support. Despite this difference all fractures went on to heal, however no functional outcomes were measured.

Angular stable plates offer high primary stability in proximal humeral fractures with firm anchorage in osteoporotic bone allowing early functional exercise even in elderly patients. Clinical results are favorable with this implant comparable to those of proximal humeral nails.

Due to their biomechanical properties, comparable to an internal fixator, extensive periosteal stripping and subsequent reduction of vascular blood supply to the humeral head can be avoided. Despite the more extensile surgical approach the rate of humeral head necrosis is low, similar to those of proximal humeral nails. An additional reduction of humeral head necrosis might be achieved by using an anterolateral deltoid-split approach with minimal invasive insertion of the plate.6,7,8

In 2007, Rose et al9reported results from early experience with the proximal locking plate in 16 patients with a mean age of 51 years. Their cohort included 5 two-part, 9 three-part, and 2 four-part fractures. Nonunions were seen in 4 (25%) patients, 3 of whom required revision operations. Of the fractures that healed, excellent clinical function was reported (mean elevation 132°, mean external rotation 43° and mean internal rotation to T11) within a mean follow-up of 1 year.

In 2008, Andrew H.CrenshawJr. Edward A.Perez, in their study concluded that, in young, active patients, open reduction and plate fixation usually are successful if soft-tissue stripping is kept to a minimum to avoid further damage to the humeral head blood supply. Rigid fixation with locking plates currently is the procedure of choice for four-part proximal humeral fractures in young, active patients10.

In 2009,Thyagarajan DS, Haridas SJ, Jones D 11reviewed 30 consecutive patients treated surgically with the proximal humeral locking plate for a displaced proximal humeral fracture. Functional outcome was determined using the American Shoulder and Elbow Society (ASES) score and Constant Murley score and results showed that good fracture stability was achieved, and the functional outcome was very good in younger patients and it declined with increasing age. The average overall ASES score was 66.5. The average overall Constant score was 57.5. Early mobilization of the shoulder can be achieved without compromising fracture union.

In a recent study, Zyto12 reported on a series of elderly patients with four-part fractures who were randomized into nonoperative treatment or open reduction and internal fixation. They observed no difference in the functional outcome between the two groups, although they did not report on whether displacement was corrected with their operative management.

APPENDIX –IC

6.3 AIMS AND OBJECTIVES OF STUDY

1.  Study the occurrence, mechanism of injury and displacement of various types of fracture according to Neer’s.

2.  Study different modalities of the fixations in proximal humerus fractures.

3.  Assess and compare the functional outcome.

4.  Come to conclusion about preferred modality of treatment of proximal humerus fractures.

APPENDIX-II

7.0 MATERIALS AND METHODS

APPENDIX-II A

7.1 SOURCE OF DATA

Patients having proximal humerus fractures, who are admitted in Sri Adichunchanagiri Institute of Medical Sciences, will be taken for study after obtaining their consent.

APPENDIX-II B

7.2 METHOD OF COLLECTION OF DATA

INCLUSION CRITERIA

1.  All adults patients admitted with proximal humerus fractures. [Neer’s classification : grade 1 to grade 2].

EXCLUSION CRITERIA

1.  Skeletally immature patients

2.  Pathological fractures,

3.  Patients with distal neurovascular deficit,

4.  Polytrauma patients with an Injury Severity Score > 16

5.  Shaft humerus fractures with proximal extension

6.  Neer’s criteria grade 3 and grade 4.

This is a prospective study from November 2010. A minimum of about 20 patients coming to Sri Adichunchanagiri Institute of Medical Sciences attending both O.P.D. and Casualty after applying appropriate criteria will be followed up for a period of 18 months with minimum of 3 visits.

EVALUATION

1.  Pain Total 35 Unit

a.  No Pain 5

b.  Slight or Occasional 30

c.  Mild, No effect in ordinary activity 25

d.  Moderate, tolerable, starting to affect ordinary activity 15

e.  Marked, serious limitation of ordinary activity 5

f.  Total Disablement 0

2.  Functional Ability Total 30 Units

a. Strength / b. Reaching / c. Stability
·  Normal
·  Good
·  Fair
·  Poor
·  Trace
·  Zero / 10
8
6
4
2
0 / ·  Above head
·  Mouth
·  Belt buckle
·  Opposite axilla
·  Brassiere hook / 2
2
2
2
2 / ·  Lifting
·  Throwing
·  Carrying
·  Pushing
·  Hold over head / 2
2
2
2
2

3.  Range of Motion Total 25 Units

Flextion / Extension / Abduction / External rotation / Internal rotation
·  1800
·  1700
·  1300
·  1000
·  800
·  <800 / 6
5
4
2
1
0 / ·  450
·  300
·  150
·  <150 / 3
2
1
0 / ·  1800
·  1700
·  1400
·  1000
·  800
·  <800 / 6
5
4
2
1
0 / ·  600
·  300
·  100
·  <100 / 5
3
1
0 / ·  900(T6)
·  700(T12)
·  500(L5)
·  300
·  <300 / 5
4
3
2
0

4.  Anatomy Total 10 Units

Rotation, Angulation, Joint incongruity, Retracted Tuberosities, Non-union, AVN

·  None 10

·  Mild 8

·  Moderate 4

·  Severe 0-2

These criteria were proposed by Neer. The maximum points are 100 units:

·  Pain : 35 Units

·  Function : 30 Units

·  Range Of Movement : 25 Units

·  Anatomy : 10 Units

On overall scores, the patients were grouped into:

1.  Results Score

2.  Excellent : > 89 units

3.  Satisfactory : 80-89 units

1. Un-Satisfactory : 70-79 units
2. Failure : < 70

Application of Biostatistics :

All the information will be collected in using a structured questionnaire. Completed questionnaires will be coded by numbers and entered in computer software. Crosschecking and data cleaning will be done.

·  Results are expressed as the number, percentages, mean ± SD as appropriate.

·  Nominal data will be compared using the chi-square test.

·  For continuous data; paired t test will be used for pre- and post comparison; and unpaired t test will be used to compare two groups.

·  P < 0.05 is considered to be statistically significant.

·  Additional exploratory (parametric as well as non-parametric) analysis of the data will be performed as deemed essential using appropriate statistical tests.

APPENDIX-II C

7.3 Does the study require any investigation or intervention to be conducted on the patients or animals , if so please describe briefly

YES

Radiographic evaluation of the shoulder were done according to Neer's trauma series which consists of:

·  A true anteroposterior (AP) view of the scapula,

·  A lateral ‘ Y-view ’ of scapula, and

·  An axillary view.

APPENDIX-IID

PROFORMA APPLICATION FOR ETHICS COMMITTEE APPROVAL

SECTION A

a / Title of the study / “STUDY OF FUNCTIONAL OUTCOME OF SURGICAL MANAGEMENT OF PROXIMAL HUMERUS FRACTURE BY VARIOUS MODALITIES”
b / Principle investigator
(Name and Designation) / DR ROHIT JAGANNATH NALAWADE,
P.G. IN ORTHOPAEDICS,
ADICHUNCHANAGIRI INSTITUTE OF
MEDICAL SCIENCES, B.G. NAGARA,
MANDYA DISTRICT -571448
c / Co-investigator
(Name and Designation) / DR. MANJAPPA. C.N.,
M.B.B.S., M.S ORTHO.,
ASSOCIATE PROFESSOR,
DEPARTMENT OF ORTHOPAEDICS,
A.I.M.S., B.G.NAGARA-571448.
d / Name of the Collaborating
Department/Institutions / NO
e / Whether permission has been obtained from the heads of the collaborating departments & Institution / NA
Section – B
Summary of the Project / APPENDIX I

Section – C

Objectives of the study

Section – D

Methodology / APPENDIX II
A / Where the proposed study will be undertaken / DEPARTMENT OF ORTHOPAEDICS

S.A.H. AND R.C., B.G.NAGARA

B / Duration of the Project /

18 MONTHS

C / Nature of the subjects:
Does the study involve adult patients?
Does the study involve Children?
Does the study involve normal volunteers?
Does the study involve Psychiatric patients?
Does the study involve pregnant women? / YES
NO
NO
NO
NO
D / If the study involves health volunteers
I.  Will they be institute students?
II.  Will they be institute employees?
III.  Will they be Paid?
IV.  If they are to be paid, how much per session? / NO
NO
NO
NO
E / Is the study a part of multi central trial? / NO
F / If yes, who is the coordinator?
(Name and Designation)
Has the trail been approved by the ethics Committee of the other centers?
If the study involves the use of drugs please indicate whether.
I. The drug is marketed in India for the indication in which it will be used in the study.
II. The drug is marketed in India but not for the indication in which it will be used in the study
III. The drug is only used for experimental use in humans.
IV. Clearance of the drugs controller of India has been obtained for:
  Use of the drug in healthy volunteers
  Use of the drug in-patients for a new indication.
  Phase one and two clinical trials
  Experimental use in-patients and healthy volunteers. / NA
-
-
NA
NA
NA
NA
NA
G / How do you propose to obtain the drug to be used in the study?
-  Gift from a drug company
-  Hospital supplies
-  Patients will be asked to purchase
-  Other sources (Explain) / NA
H / Funding (If any) for the project please state
-  None
-  Amount
-  Source
-  To whom payable / NO
I / Does any agency have a vested interest in the out come of the Project? / NO
J / Will data relating to subjects /controls be stored in a computer? / YES
K / Will the data analysis be done by
-  The researcher?
-  The funding agent / YES
NO
L / Will technical / nursing help be required form the staff of hospital.
If yes, will it interfere with their duties?
Will you recruit other staff for the duration of the study?
If Yes give details of
I.  Designation
II.  Qualification
III.  Number
IV.  Duration of Employment / NO
NO
NO
NA
M / Will informed consent be taken? If yes
Will it be written informed consent:
Will it be oral consent? Will it be taken from the subject themselves?
Will it be from the legal guardian? If no, give reason: / YES, CONSENT WILL BE TAKEN FROM THE PATIENT
N / Describe design, Methodology and techniques / APPENDIX II

Ethical clearance has been accorded.