RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
BANGALORE, KARNATAKA
SYNOPSIS
DISTAL TIBIAL FRACTURE FIXATION WITH LOCKING COMPRESSION PLATE USING MINIMALLY INVASIVE PERCUTANEOUS OSTEOSYNTHESIS TECHINQUE
Name of the candidate : DR.KARAN ALVA K
Guide : DR.SHRIDHAR SHETTY
Course and subject : M.S (ORTHOPAEDICS)
DEPARTMENT OF ORTHOPAEDICS,
A.J. INSTITUTE OF MEDICAL SCIENCES
KUNTIKANA, MANGALORE-575004
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA.
SYNOPSIS FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1 / NAME OF THE CANDIDATE / DR KARAN ALVA KPOST GRADUATE RESIDENT,
DEPARTMENT OF ORTHOPAEDICS,
AJ INSTITUTE OF MEDICAL SCIENCES,
MANGALORE.
2 / NAME OF THE INSTITUTION / AJ INSTITUTE OF MEDICAL SCIENCES, KUNTIKANA, MANGALORE 575004
3 / COURSE OF STUDY AND SUBJECT / MS ORTHOPAEDICS.
4 / DATE OF ADMISSION TO COURSE / 25th APRIL 2011
5 / TITLE OF THE TOPIC:
“STUDY OF DISTAL TIBIAL FRACTURE FIXATION WITH LOCKING COMPRESSION PLATES(LCP) USING MINIMALLY INVASIVE PERCUTANEOUS OSTEOSYNTHESIS(MIPO) TECHNIQUE”
6 / BRIEF RESUME OF INTENDED WORK:
6.1. NEED FOR THE STUDY:
Treatment of distal tibial fractures has always been challenging. Closed fractures of the tibial shaft traditionally have been treated with closed reduction and a cast. Open reduction and internal fixation (ORIF) was reserved for situations in which an adequate reduction could not be obtained or maintained by conservative means. ORIF often necessitates extensive dissection and tissue devitalisation, creating an environment less favourable for fracture union and more prone to bone infection. As a result, other, less invasive methods were developed to treat diaphyseal fractures of the tibia.
We aim to see the results of the distal tibial fracture fixation with Locking Compression Plate (LCP) using Minimally Invasive Plate Osteosynthesis (MIPO).
These techniques are based upon the principles of limited soft tissue stripping, maintenance of the osteogenic fracture hematoma, and preservation of vascular supply to the individual fracture fragments while restoring axial and rotational alignment, and providing sufficient stability to allow progression of motion, uncomplicated fracture healing, and eventual return to function.
6.2. REVIEW OF LITERATURE:
Borelli et al1 showed that the risk of disruptingbloodsupply is increased with the classic approach ORIF in the metaphyseal region of the tibia. Even if technically more demanding and requiring a higher exposure to radiation because of closed indirect reduction, MIPO may have a biological advantage over ORIF, especially when dealing with critical soft tissue conditions.
E. Hasenboehler et al2 reinstated the fact that MIPO technique using LCP plates is a reliable approach towards diaphyseal and distal tibia shaft fractures that are not suitable for intramedullary nailing. Soft tissue complications, misalignment and knee irritation problems are avoided. Based on their clinical and radiological definition of fracture healing, out of 32 patients a total of 24 patients were classified as healed at 6 months, 27 patients at 9 months, and 29 patients at 15 months post-operatively.
In a study conducted by Redfern et al320 patients were treated by MIPO for closed fractures of the distal tibia. Their mean age was 38.3 years (range: 17–71 years). Fractures were classified according to the AO system. The mean time to full weight-bearing was 12 weeks (range: 8–20 weeks) and to union was 23 weeks (range: 18–29 weeks), without need for further surgery. There was one malunion, no deep infections and no failures of fixation.
Lau et al4 had conducted a study among 48 patients with special attention to infection rate. Their results showed that the average time until the patient started to bear full weight was 9.4 weeks. The average time for bony union was 18.7 weeks. There were 7 cases of late infection among these 48 cases (15%). Twenty five patients (52%) had the implants removed and the most common reason was skin impingement by the implant. However, complications such as late wound infection and impingement by the implant are relatively common. The overall clinical outcome was still good despite the presence of these complications.
Leung FK et al5 showed that MIPO LCP in treatment of distal tibial fractures were satisfactory without any incidence of serious complications. Among 62 patients, near anatomical reduction was achieved in 56 fractures and acceptable reduction in 6 fractures.
Mario Ronga et al6 studied the effectiveness of minimally invasive locked plates among 21 patients for a minimum period of 2 years (average: 2.8 years). According to the AO classification, there were 12 Type A, 5 Type B, and 4 Type C fractures. Two patients were lost to follow-up. Union was achieved in all but one patient by the 24th postoperative week. Four patients had angular deformity less than 7°. No patient had a leg-length discrepancy more than 1.1cm. Five patients had ankle range of motion less than 20° compared with the contra lateral side. Sixteen patients had not returned to their pre-injury sporting or leisure activities. Three patients developed a delayed infection.
6.3. OBJECTIVES OF THE STUDY:
The proposed study aims to assess the role of minimally invasive locking compression plates in treatment of distal tibial fractures.
Objectives of the study are to study postoperative
i. mobilisation,
ii. time to union,
iii. functional outcome in the form of range of motion and
iv. complications.
7 / MATERIALS AND METHODS:
7.1. SOURCE OF DATA:
Patients undergoing fixation of distal tibial fractures with locked compression plates using MIPO technique in A J Institute of Medical Sciences, Mangalore during July 2011 and July 2013.
7.2. METHOD OF COLLECTION OF DATA:
The patients coming to A J Institute of Medical Sciences between July 2011 and July 2013 with distal tibial fractures. The patients treated with locking compression plates using MIPO would be reviewed for inclusion and exclusion criteria’s. The patients will be followed minimum for 1year, upto 2 years. Patients fitting into inclusion criteria, followed for required period would form the study group.
Type of Study :
Prospective study
SELECTION CRITERIA:
Inclusion Criteria.
1) Patients above 14 years
2) AO Classification distal tibia fractures
3) Fibular fractures
4) Intraarticular / Periarticular fractures
Exclusion Criteria.
1) Patient less than 14 years
2) Gustillo Anderson III open fractures
3) Associated vascular injuries
4) Pathological fractures
5) Compartment syndrome
6) Delayed Surgery with shortening of limb
7) Ankle dislocation and Talus fractures
8)Associated tibial condyle fracture
Statistical Analysis:
Data collected will be analysed by using proper statistical test
7.3 Does the study require any investigation or interventions to be conducted on patients or other human or animals? If so, please describe briefly.
No.
7.4 Has the ethical clearance obtained from your institution
Clearance awaited.
8 / LIST OF REFERENCES:
1. S.M. Perren, Evolution of the internal fixation of long bone fractures. The scientific basis of biological internal fixation: choosing a new balance between stability and biology.J Bone Joint Surg Br,84-8 (2002), pp. 1093–1110.
2 . E. Hasenboehler, D. Rikli, R. Babst, Locking Compression Plate with Minimally Invasive Plate Osteosynthesis in diaphyseal and distal tibial fracture: A retrospective study of 32 patients, Injury, Volume 38, Issue 3, March 2007, Pages 365-370
3. D.J Redfern, S.U Syed, S.J.M Davies, Fractures of the distal tibia: minimally invasive plate osteosynthesis, Injury, Volume 35, Issue 6, June 2004, Pages 615-620
4. Lau TW, Leung F, Chan CF, Chow SP. Wound complication of minimally invasive plate osteosynthesis in distal tibia fractures. Int Orthop. 2008 October; 32 : 697 – 703.
5. Leung FK,Law TW. Application of minimally invasive locking compression plate in treatment of distal tibia fractures. Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi.2009 Nov;23(11):1323-5
6. Mario Ronga,Umile Giuseppe LongoandNicola Maffulli. Minimally Invasive Locked Plating of Distal Tibia Fractures is Safe and Effective. Clinical Orthopaedics and related Research. Volume 468, Number 4,975-982
9. / SIGNATURE OF THE CANDIDATE:10. / REMARKS OF THE GUIDE
11. / 11.1 NAME AND DESIGNATION OF GUIDE
(in block letters) / DR. SHRIDHAR SHETTY,
ASSOCIATE PROFESSOR,
DEPARTMENT OF ORTHOPAEDICS,
A J INSTITUTE OF MEDICAL COLLEGE,
MANGALORE
11.2 SIGNATURE
11.3 CO GUIDE (if any) / -
11.4 SIGNATURE / -
11.5 HEAD OF THE DEPARTMENT / DR. SUDARSHAN BHANDARY,
PROFESSOR & H.O.D,
DEPARTMENT OF ORTHOPAEDICS,
A J INSTITUTE OF MEDICAL SCIENCE,
KUNTIKANA, MANGALORE
11.6 SIGNATURE
12. / 12.1 REMARKS OF THE CHAIRMAN AND PRINCIPAL
12.2 SIGNATURE
PROFORMA SHEET
NAME :
SEX :
AGE : DATE OF ADMISSION:
IP/OP no : DATE OF DISCHARGE:
History of injury:
Date of injury:
Mechanism of injury: Direct:
Indirect:
Any other associated injury:
Details of primary treatment received:
Past History:
Previous mobility of the patient:
Any coexisting systemic illness:
Details (if any) of the treatment patient is (was) receiving:
Systemic diseases:
Personal History:
Smoking / Alcohol:
General Physical Examination:
Local examination :
Inspection:
Palpation:
Measurement:
Movements:
Investigations :
Blood:
X- ray examination:
CT (if done):
MRI (if done):
Type of fracture (class):
Closed/ Open (type):
Side:
Treatment:
Surgery:
Date of surgery:
Duration of surgery:
Surgical approach:
Implant used (with exact dimensions and holes):
Placement of implant:
Bone graft used:
Number and type of screws used:
Postoperative Management:
Post op slab / cast application with duration :
Days of hospitalization:
Days of starting non weight bearing mobilization:
Days of starting partial weight bearing mobilization:
Days of starting full weight bearing mobilization:
Complications:
Infection
Compartment Syndrome
Angulations (varus/valgus)
Shortening
Implant loosening
Others
Death with its cause
Follow-Up:
Pain
Radiological union
American Orthopaedic Foot and Ankle Society Ankle – Hindfoot Scale:
(AOFAS Ankle – Hindfoot scale)
Pain (40 points)None
Mild, occasional
Moderate , daily
Severe, almost always present / 40
30
20
0
Function (50 points)
Activity limitations, support requirement
No limitations, no support
No limitations of daily activities, limitations of recreational activities, no support
Limited daily and recreational activities, cane
Severe limitations of daily and recreational activities, walker, crutches, wheelchair, brace / 10
7
4
0
Maximum walking distance, blocks
Greater than 6
4 – 6
1 – 3
Less than 1 / 5
4
2
0
Walking surface
No difficulty on any surface
Some difficulty on uneven terrain, stairs inclines, ladders
Severe difficulty on uneven terrain, stairs, inclines, ladders / 5
3
0
Gait abnormality
None, slight
Obvious
Marked / 8
4
0
Sagittal motion (flexion plus extension)
Normal or mild restriction (30 ̊ or more)
Moderate restriction (15 ̊ - 29 ̊)
Marked restriction ( less than 15 ̊ ) / 8
4
0
Hindfoot motion ( inversion plus eversion)
Normal or mild restriction (75% - 100% normal)
Moderate restriction (25% - 74% normal)
Marked restriction ( less than 25% normal) / 6
3
0
Ankle- hindfoot stability (anteroposterior, varus-valgus)
Stable
Definitely unstable / 8
0
Alignment (10 points)
Good, plantigrade foot, midfoot well aligned
Fair, plantigrade foot, some degree of midfoot malalignment observed , no symptoms
Poor, nonplantigrade foot, severe malalignment, symptoms / 15
8
0
Total / 100
TIME PLAN
TITLE:
“STUDY OF DISTAL TIBIAL FRACTURE FIXATION WITH LOCKING COMPRESSION PLATES(LCP) USING MINIMALLY INVASIVE PERCUTANEOUS OSTEOSYNTHESIS(MIPO) TECHNIQUE”
PHASE / TIME PERIOD / OUTLINE OF PLANI / June 2011
to
November 2011 / 1. Identification of problem
2. Review of Literature
3. Development of proforma
4. Conducting pilot study
5. Submission of synopsis
II / December 2011
to
May 2013 / 1. Enrollment
2. Data Collection
3. Follow up
III / June 2013
to
November 2013 / 1. Analysis of collected data
2. Discussion
3. Publication
A J INSTITUTE OF MEDICAL SCIENCES,
KUNTIKANA, MANGALORE
Informed consent form for the patients of “A.J Institute of Medical Sciences Kuntikana, Mangalore”, who will be participating in the research project (MS dissertation) titled “DISTAL TIBIAL FRACTURE FIXATION WITH LCP USING MIPO TECHINQUE”
Name of Principal Investigator / Dr. Karan Alva KJunior Resident.
Name of Organization / Department of Orthopaedics,
A.J Medical Sciences, Kuntikana, Mangalore
This Informed Consent Form has two parts:
· Information Sheet (to share information about the research with you)
· Certificate of Consent (for signatures if you agree to take part)
You will be given a copy of the full Informed Consent Form
PART I: Information Sheet
Introduction
I, Dr. Karan Alva K, Junior Resident in the department of Orthopaedics, A.J Institute of Medical Sciences, Kuntikana, Mangalore, is working on my MS dissertation titled “DISTAL TIBIAL FRACTURE FIXATION WITH LCP USING MIPO TECHINQUE”. My study subjects will be patients of AJIMS, who are admitted here and are being treated for Distal Tibial fractures.
I am going to give you information and invite you to be part of this research. You do not have to decide today whether or not you will participate in the research. Before you decide, you can talk to anyone you feel comfortable with about the research. Your decision to participate or not to participate will not have any effect on your treatment in our hospital. There may be some words that you do not understand. Please ask me to stop as we go through the information and I will take time to explain. If you have questions later, you can ask them and get yourself clarified.
Purpose of the research
1. To improve mode of management.
2. To reduce rate of postoperative complications
3. For early pain free mobilisation
Treatment of distal tibial fractures has always been challenging. Closed fractures of the tibial shaft traditionally have been treated with closed reduction and a cast. Open reduction and internal fixation (ORIF) was reserved for situations in which an adequate reduction could not be obtained or maintained by conservative means. ORIF often necessitates extensive dissection and tissue devitalisation, creating an environment less favourable for fracture union and more prone to bone infection. As a result, other, less invasive methods were developed to treat diaphyseal fractures of the tibia.
We aim to see the results of the distal tibial fracture fixation with Locking Compression Plate (LCP) using Minimally Invasive Plate Osteosynthesis (MIPO).
Type of Research Intervention
It is a hospital based prospective cross sectional study. All patients admitted at AJIMS for treatment of distal tibial fractures who fit the inclusion criteria, in a time period of two years will be enrolled in this study after providing informed consent to participation.