From,
Dr. SATHISH BABU D G
Post-graduate in Orthopaedics
Department of Orthopaedics
Mysore Medical College & Research Institute
Mysore.
To,
Registrar (Evaluation)
Rajiv Gandhi University of Health Sciences
Bangalore.
Through proper channel.
Respected Sir,
Subject: Submission of Synopsis titled “ A CLINICAL STUDY ON SURGICAL MANAGEMENT OF PROXIMAL HUMERAL FRACTURES BY LOCKING PLATES"
I am hereby submitting the above titled synopsis (4 copies) as mentioned above, so kindly accept my application and do the needful.
Thanking you,
Yours faithfully,
(DR. SATHISH BABU D G)
Forwarded to Dean and Director, MMC & RI, Mysore for further needful action
Professor and Head,
Date: Department of Orthopaedics
Place: MMC & RI, Mysore
ETHICAL COMMITTEE CLEARANCE
1. Title of Dissertation : “ A CLINICAL STUDY ON SURGICAL MANAGEMENT
OF PROXIMAL HUMERAL FRACTURES BY LOCKING
PLATES"
2. Subject : M.S. ORTHOPAEDICS
3. Name of the Candidate : DR. SATHISH BABU D G
4. Name of the Guide : DR. P.S.KALADAGI
M.S(ORTHO)
Professor and HOD
Department of Orthopaedics
Mysore Medical College &
Research Institute, Mysore.
5. Approved / not approved
(If not approved, suggestions) : APPROVED
MEMBERS OF THE ETHICAL CLEARANCE COMMITTEE
PROFESSOR HOD PROFESSOR & HOD
DEPARTMENT OF SURGERY DEPARTMENT OF MEDICINE,
MYSORE MEDICAL COLLEGE & MYSORE MEDICAL COLLEGE &
RESEARCH INSTITUTE, RESEARCH INSTITUTE,
MYSORE MYSORE
MEDICAL SUPERINTENDENT MEDICAL SUPERINTENDENT
K. R. HOSPITAL CHELUVAMBA HOSPITAL
MYSORE MYSORE
MEDICAL SUPERINTENDENT LAW EXPERT
PKTB HOSPITAL
MYSORE
DEAN AND DIRECTOR
MYSORE MEDICAL COLLEGE
& RESEARCH INSTITUTE
MYSORE
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
KARNATAKA, BANGALORE
ANNEXURE - II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1. Name of the candidate : and address / DR.SATHISH BABU DG P.G. IN ORTHOPEDICS ROOM NO. 10, PG & INTERNS HOSTEL FOR MEN, GOVERNMENT MEDICAL COLLEGE, MYSORE-5700212. Name of the institution : / MYSORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, MYSORE
3. Course of study and : Subject / POST GRADUATE IN
M.S ORTHOPAEDICS
4. Date of admission to : course / 31st MAY 2011
5. Title of topic : / “ A CLINICAL STUDY ON SURGICAL MANAGEMENT OF PROXIMAL HUMERAL FRACTURES BY LOCKING PLATES"
6. Brief resume of the intended work :
6.1 Need for the study:
Proximal humerus fractures are common and debilitating injuries and incidence of them are increasing especially in elderly. They accounts for about 5% of all injuries to appendicular skeleton. They are the third most common fractures in elderly population after hip and distal radius fractures. Increase in incidence is due to more geriatric population with osteoporotic bone with an annual incidence of between 63to105 fractures per 1 lakh.
Mechanism of injury is high energy injuries like road traffic accident, sports injuries, fall from height or gunshot wounds in adolescents and young adults however in elderly low energy injuries like domestic falls are more common.
The treatment goal is to achieve a painless shoulder with full functional outcome. Regarding treatment of proximal humerus fractures controversies still exists whether to do conservative or operative management. Various operative procedures are carried out like percutaneous pinning, tension band wiring, platting, rush nailing. Recent method of internal fixation is with locking plates. Locking plates provides rigid fixation and more angular stability compared to other method of operative treatment of proximal humerus fractures and helps in early mobilization and physiotherapy which leads to achieve a painless shoulder with good functional outcome.
So we decided to study & evaluate the results of internal fixation with locking plates to confirm its present day relevance.
6.2 REVIEW OF LITERATURE :
Hippocrates first documented a proximal humerus fracture in 460 BC and treated it with traction. In 1869, to improve treatment, Krocher classified fractures of the proximal humerus. In 1934, Codman developed a classification that divided the proximal humerus into 4 parts, based on epiphyseal lines. In 1970, Neer‘s classification expanded on the 4-part concept and included anatomic, biomechanical, and treatment principles, providing clinicians with a useful framework to diagnose and treat patients with these fractures
C.P. Charalambous et al (2007) Conducted prospective study of 25 cases of proximal humerus fractures treated with locking plates .out of 25 cases 20 went for union with mean neck shaft angel of 127.2 degree .Five cases required or were considered for revision surgery for non-union or implant failure. Author concluded that locking plates are effective system for providing fracture stabilization to bony union but awareness of potential hardware complication is essential.
Kenmet A.Egol et al (2008) A retrospective analysis was undertaken of consecutive series of proximal humerus fractures treated with locking plates between feb 2003 and jan 2006. 51 patients were included in study with a minimum of 6 months of follow up. Overall 12 patients (24%) developed complication with success rate of 76%.
MA Fazal, FS Haddad(2009) Prospective study of 27 patients underwent locking plate fixation for displaced proximal humerus fractures. All fractures were united with 1 patient going for complication, which is srew penetration subsequently developed nonunion and avascular necrosis. Study concluded that locking plate fixation provided stable fixation , minimal metal work problem and enabled early range of motion exercise to achieve acceptable functional outcome
BD Solberg, CN Moon, DP Franco… conducted a retrospective study in 70 patients and the results are ; Neer 3- and 4-part proximal humeral fractures in older patients with initial varus angulation of the humeral head had a significantly worse clinical outcome and higher complication rate than similar fracture patterns with initial valgus angulation. Two factors had significant influence on final outcome in these fracture patterns: initial direction of the humeral head angulation and length of the intact metaphyseal segment attached to the articular fragment. The best clinical outcomes were obtained in valgus impacted fractures with a metaphyseal segment length of greater than 2 mm, and this was independent of Neer fracture type. Humeral head angulation had the greatest effect on final outcomes (P< 0.001), whereas metaphyseal segment length of less than 2 mm was predictive of developing avascular necrosis (P< 0.001).
Michael Leonard,Leibo Mokotedi and etal(2009) conducted a prospective study in 31 patients and the results are ; Average functional scores (minimum 18 months post operation) per AO / ASIF fracture type were 25.3 for type A, 21.4 for type B, and 22.7 for type C. There was no statistically significant difference between the groups. The functional scores for patients over 65 years of age were significantly inferior (P= 0.03). At a final radiological review (mean 12 months post operation), 30 (96%) of the patients demonstrated fracture union. Seven patients (22.5%) required a second surgical procedure.
6.3 OBJECTIVES OF THE STUDY:
· To study the efficacy, functional outcome and time taken for union of the fracture following surgery with locking plates in proximal humeral fractures.
· To evaluate the incidence of complication that may occur with locking plates in proximal humeral fractures
7. MATERIALS AND METHODS :
7.1 Source of data :
The proposed study is a prospective study centered in K.R Hospital attached to the Government Medical College and research institute, Mysore during the term between January 2012 to October 2013.
7.2 Method of collection of data (including sampling procedures if any): In the proposed study a minimum of 20 cases presenting with proximal humeral fractures admitted to K R hospital are evaluated clinically and radiologically. The fractures are classified by using Neer’s classification.
Routine investigations will be carried out in order to get fitness for surgery. Consent of the patient will be taken.
Patient under goes open reduction and internal fixation with locking plates under brachial plexus block or general anesthesia. Patient will be followed periodically and the functional outcome, range of movements, time required for fracture union and complications will be studied in detail.
Inclusion Criteria
· Age group : >18years
· Gender : Male and female patients.
· Two part, three part and four part fracture of proximal humerus (Neer’s classification)
· Patients who are willing to participate in the study
Exclusion Criteria
· Children and adolescent patients <18yrs
· Compound fractures
· Undisplaced fractures
· Fractures associated with neurovascular deficits
· Patients not willing for surgery.
· Fractures associated with dislocation.
7.3 Sampling Procedure:-
· Consent of the patient
· History
· Clinical examination
· Radiological examination
7.4 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so, please describe briefly.
YES It requires the following investigations
Blood : Hb, BT, CT,
Blood :RBS, B.UREA, & S.CREATININE
BLOOD GROUPING, HIV, HbsAg
ECG : In all leads
RADIOGRAPHS: AP VIEW ,AXIAL VIEW(OPTIONAL)
Has Ethical clearance been obtained from your institute
YES Copy enclosed
8. LIST OF REFERENCES :
1. Mark Frankle, MD; Chief Editor: Mary Ann E Keenan, MD emedicine.medscape.com/article/1261320-overview
2. Bahrs C, Rolauffs B, Dietz K, Eingartner C, Weise K. Clinical and radiological evaluation of minimally displaced proximal humeral fractures.Arch Orthop Trauma Surg. Oct 7 2009
3. Neer CS 2nd. Displaced proximal humeral fractures. I. Classification and evaluation.J Bone Joint Surg Am. Sep 1970;52(6):1077-89.
4. Monga P, Verma R, Sharma VK. Closed reduction and external fixation for displaced proximal humeral fractures.J Orthop Surg (Hong Kong). Aug 2009;17(2):142-5.
5. Brunner F, Sommer C, Bahrs C, Heuwinkel R, Hafner C, Rillmann P, et al. Open reduction and internal fixation of proximal humerus fractures using a proximal humeral locked plate: a prospective multicenter analysis.J Orthop Trauma. Mar 2009;23(3):163-72
6 C.P Charalambous, I .siddiqe, et al “Proximal humerus internal locking system for the treatment of proximal humerus fracture” Archieve of Orthopaedic and truama surgery (2007)127:205-210
7 Kenneth A Egol,MD, Crispin C.Ong et al “Early complication in proximal humerus fractures treated with locked plates” Journal orthopaedic truma 2008;22:159-164
8 MA Fazal, FS Haddad “PHILOS plate fixation for displaced proximal humeral fractures” Journal of orthopaedic surgery 2009;17(1)15-8
9 BD Solberg, CN Moon, DP Franco…Journal of Orthopaedic Trauma: February 2009 - Volume 23 - Issue 2 - pp 113-119
10 Reto Babst,Flexi Brunner “Plating in proximal humerus fractures” European Jornal of trauma and emergency surgery 2007:33;345-56
11 Jon J.P. warner, John G.costouror and Christian Gerger “Fractures of proximal humerus” In Rookwood and Green s fracture in adults 6th edition lippincott William ad wilkim 1161-1209pp.
9. Signature of the candidate :
( Dr. SATHISH BABU D G)
10. Remarks of the guide :
11.Name and designation of (in block letter)
11.1 Guide / Dr.KALADAGI.P.S
Professor & HOD, Department of Orthopedics
K.R. Hospital Government Medical College and research institute, Mysore
11.2 Signature of guide:
11.3 Co-Guide (if any) / Dr.NEELANAGOWDA .V.POLICE PATIL Assistant Professor, Department of Orthopedics
K.R. Hospital, Government Medical College and Research Institute, Mysore
11.4 Signature of co-guide:
11.5 Head of Department / Dr.KALADAGI.P.S
Professor & HOD, Department of Orthopedics,
K.R. Hospital, Government Medical College and Research Institute Mysore
11.6 Signature of HOD
12. Remarks
12.1 Remarks of Dean and director:
12.2 Signature :