RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA
PROFORMA FOR REGISTRATION OF DISSERTATION
TOPIC
“PROSPECTIVE COMPARATIVE STUDY OF CLOSED REDUCTION AND ABOVE ELBOW CAST VERSUS CLOSED REDUCTION AND PERCUTANEOUS K-WIRE FIXATION IN COMPLETELY DISPLACED DISTAL RADIUS METAPHYSEAL FRACTURES IN CHILDREN”
DR BIJU P A
POSTGRADUATE
DEPARTMENT OF ORTHOPAEDIC SURGERY
K.S.HEGDE MEDICAL ACADEMY
DERALAKATTE, MANGALORE - 575018.
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA.
PROFORMA FOR REGISTRATION OF DISSERTATION
1 / Name of the candidate and address / DR BIJU P ADilkhush
Mayyanad Road, Kottiyam P.O
Kollam, Kerala. 691571
2 / Name of the institution / Justice K.S Hegde Charitable Hospital,
University Road, Deralakatte,
Mangalore – 575018
Karnataka.
3 / Subject / Orthopaedic Surgery
4 / Date of admission to course / 26-5-2008
5 / Title of the topic / “PROSPECTIVE COMPARATIVE STUDY OF CLOSED REDUCTION AND CAST IMMOBILISATION VERSUS CLOSED REDUCTION AND K-WIRE FIXATION IN COMPLETELY DISPLACED DISTAL RADIUS METAPHYSEAL FRACTURES IN CHILDREN”
6. / Brief resume of the intended work
6.1 Need for the study:
Fractures of forearm bones are sometimes so complex that they demand the utmost of a well seasoned orthopaedic surgeon. Traditionally fractures of distal radius in children have been treated by closed reduction and immobilization in plaster cast.2 Maintenance of satisfactory alignment is difficult4. Recent studies indicate high rate of redisplacement, reangulation and remanipulation following closed reduction and cast immobilisation2,3,4. Supplementary percutaneous K-wire fixation resulted in a significantly better maintenance of the alignment of the completely displaced fractures of the distal radius in children2. Complications are known to occur in both the groups1. Hence, this prospective comparative study of closed reduction and cast immobilization versus closed reduction and K-wire fixation in completely displaced distal radius metaphyseal fractures in children is planned.
6.2. Review of literature:
q Bruce S Miller et al.1 conducted a similar study in children older than 10 years of age with more than 30 degrees of dorsal angulation or with complete fracture displacement with an average follow up period of 10.5 wks and concluded that 39% of patients treated with casting had subsequent loss of reduction requiring remanipulation and there were no cases of loss of reduction in patients treated with pin fixation.
q G. J. McLauchlan et al.2 did a prospective, randomised controlled trial involving 68 children who had a completely displaced metaphyseal fracture of the distal radius and were treated either by manipulation (MUA) and application of an above-elbow cast alone or by the additional insertion of a percutaneous Kirschner (K-) wire. They concluded that completely displaced fractures of the distal radius in children have a high propensity for redisplacement, despite satisfactory initial reduction. Supplementary percutaneous K-wire fixation resulted in a significantly better maintenance of the alignment of the fracture. It was safe and reduced the need for follow-up radiographs and further procedures to correct loss of position with no detrimental effect on the outcome.
q M.T. Proctor et al.3 reviewed 68 cases of distal radius fractures in children treated by primary manipulation and plaster immobilisation and have identified two factors which increase the chance of redisplacement of forearm fractures in children, the presence of complete displacement and failure to achieve a perfect reduction. They recommended the use of K-wire to maintain satisfactory position in all cases in which a perfect reduction cannot be achieved.
q G.V. Mani et al.4 conducted a retrospective analysis of 94 children with distal radius fracture treated with primary closed reduction and plaster casting showed 94% overall failure rate due to irreducibility, inability to maintain reduction and eventual limitation of rotation. They also indicated that severe translation of the radius, besides being a highly significant risk factor, is a good predictor of failure
q K. Y. Choi et al5 studied 157 cases of percutaneous Kirschner-wire pinning for severely displaced distal radial fractures in children. They opined that such fractures, a high risk of failure were due to translation of the fracture by more than half the diameter of the bone. Closed reduction with percutaneous K-wiring should be the preferred procedure in such cases. It is easy to perform and the associated risk is minimal.
q J. A. Roberts7 while studying angulation of the radius in children’s fractures opined that it is important to maintain the interosseous gap during the treatment of these fractures and that radial deviation of the radius is more important than dorsal angulation.
6.3 Objectives of the study-
· To do prospective comparative study of closed reduction and above elbow cast versus closed reduction and percutaneous K-wire fixation in completely displaced metaphyseal fractures of distal radius in children
· To study loss of reduction, if any in each of the two groups
· To study the range of motion of wrist and elbow including supination and pronation in each of the two groups
· To study the radiological malunion in each of the two groups
· To compare the complications in each of the above groups
7 / Materials and methods-
7.1 Source of data- Skeletally immature patients upto the age of 14 years sustaining completely displaced metaphyseal fractures of the distal radius ,presenting to the orthopaedic department of K.S.Hegde Charitable hospital from June 2008 to July 2010 are included in the study after explaining the procedure and getting the parental consent. A minimum of thirty patients will be studied.
7.2 Method of collection of data:
All skeletally immature patients upto the age of 14 years with completely displaced metaphyseal fractures of the distal radius will be clinically evaluated and radiologically analyzed. At the time of presentation a detailed history is taken. A note is made regarding age, sex, chief symptoms, duration of symptoms and the mechanism of injury. A thorough examination is done and the cases requiring surgery will be investigated by routine laboratory tests for blood and urine and imaging studies in the form of X-ray and other appropriate investigations. Patients will be randomly assigned to the two groups (one group is closed reduction and above elbow plaster cast and other group is closed reduction and percutaneous K- wire fixation alone) after obtaining consent for inclusion into the study. Parental consent prior to procedure and inclusion into the study will be taken .The procedures shall be done under GA under image intensifier guidance in the operating room. The management of each patient will depend on the respective assigned group.
Group1 patients assigned to cast treatment will be put in an above elbow plaster cast for a period of 4 weeks with an arm sling, shoulder and finger exercises shall be started immediately and the patient is followed up at 2,4 ,6 , 12 and 24 weeks.
Group 2 patients are those who will be treated with K-wire fixation. Patient is put on an arm sling and exercises of the finger, wrist, forearm and elbow is initiated immediately.
Postoperative evaluation will be done based on clinical findings and radiographic evidence at 2 , 4, 6 ,12 and 24 weeks. Evaluation will be done with Gartland and Werley9 Scoring and Lidstrom8 scoring systems
7.3. Inclusion Criteria
· All patients with completely displaced metaphyseal fractures of distal radius (Complete fracture of the distal radius metaphysis defined as located within 4cm of the distal radius physis with angulation greater than 30 degrees or complete displacement) who have given consent for procedure.
· Patients upto the age of 14 years
7.4 Exclusion Criteria
· Patients above the age of 14 years or skeletally mature patients
· Open fractures
· History of previous injury or surgery of the affected wrist
· Fractures requiring open reduction
· Swelling or neurovascular compromise precluding circumferential cast immobilization
· Polytrauma patients
7.5 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so please describe briefly.
Yes
X-rays
Routine investigations (blood, urine)
HIV, HbsAg
7.6 What is the statistical significance of your study?
Chi-square and Fisher exact tests (non parametric tests) will be used to see the differences of dependant variables in two groups. Proportions are used to know the differences between the two groups. Likert’s scale is used for grading .Z-test will be used to compare the outcome of two groups.
7.7 Has ethical clearance been obtained from your institution in case of 7.5?
Yes
8. / List of references
1. Miller BS, Taylor B, Widmann RF, Bae DS, Snyder BD, Waters PM. Cast immobilization versus percutaneous pin fixation of displaced distal radius fractures in children: a prospective randomized study. J Pediatr Orthop 2005;25:490-494.
2. McLauchlan GJ, Cowan B, Annan IH. et al. Management of completely displaced metaphyseal fractures of the distal radius in children. A prospective randomized controlled trial. J Bone Joint Surg(Br) 2002;84:413-417
3. Proctor MT, Moore DJ, Paterson JMH. Redisplacement after manipulation of distal radius fractures in children. J Bone Joint Surg(Br) 1993;75:453-454
4. Mani GV, Hui PW, Cheng JCY. Translation of the radius as a predictor of outcome in distal radial fractures in children. J Bone Joint Surg(Br) 1993;75:808-811
5. Choi KY, Chan WS, Lam TP et al. Percutaneous Kirschner wire pinning for severely displaced distal radius fractures in children. A report of 157 cases. J Bone Joint Surg ( Br) 1995;77:797-801
6. Fuller DJ, McCullough CJ. Malunited fractures of the forearm in children. J Bone Joint Surg(Br) 1982;64:364-367
7. Roberts JA. Angulation of the radius in children’s fractures. British Editorial Society of Bone And Joint Surgery. November 1986;Vol.68B,No 5
8. Lidstrom A(1959) Fractures of the distal end of radius. A clinical and statistical study of the end results. Acta Orthop Scand Suppl 41:1-118
9. Gartland JJ, Werley CW(1951) Evaluation of healed Colle’s fractures. J Bone Joint Surg 33-A:895-907
68VOL. 68 B. No. S. NOVEMBER 986
9. / 9.SIGNATURE OF THE CANDIDATE:
10. / 10.REMARKS OF THE GUIDE :
11. / 11.1 NAME AND DESIGNATION
OF THE GUIDE: / Dr. B Jayaprakash Shetty (MBBS,D.ORTHO,MS ORTHO)
Professor and HOD, Department of Orthopaedic Surgery
Justice K.S.Hegde Charitable hospital
Deralakatte, Mangalore
11.2 SIGNATURE OF THE GUIDE:
11.3 CO-GUIDE
11.4 SIGNATURE OF CO-GUIDE:
11.5 HEAD OF THE
DEPARTMENT: / Dr. B Jayaprakash Shetty (MBBS,D.ORTHO,MS ORTHO)
Professor and HOD
Justice K.S.Hegde Charitable hospital
Deralakatte, Mangalore
11.6 SIGNATURE OF THE HEAD OF THE DEPARTMENT:
12: / 12.1 REMARKS OF CHAIRMAN
AND PRINCIPAL
12.2 SIGNATURE
K.S.HEGDE MEDICAL ACADEMY DERALAKATTE
MANGALORE
INFORMED CONSENT FORM
TOPIC: “ PROSPECTIVE COMPARATIVE STUDY OF CLOSED REDUCTION AND CAST IMMOBILISATION VERSUS CLOSED REDUCTION AND K-WIRE FIXATION IN COMPLETELY DISPLACED DISTAL RADIUS METAPHYSEAL FRACTURES IN CHILDREN”
I ……………………………….…………………………. declare that I have been briefed and hereby consent to include my son/daughter as a subject in the following dissertation “ PROSPECTIVE COMPARATIVE STUDY OF CLOSED REDUCTION AND CAST IMMOBILISATION VERSUS CLOSED REDUCTION AND K-WIRE FIXATION IN COMPLETELY DISPLACED DISTAL RADIUS METAPHYSEAL FRACTURES IN CHILDREN”
I have been informed to my satisfaction by the attending doctor Dr.Biju P A, the purpose of the study and also investigations required like X-ray, routine blood and urine investigations required to get fitness for surgery and also Surgery in the form of above elbow POP cast or Percutaneous K- wire fixation under GA .This has been explained to me in the language I understand and I fully consent for the same.
SIGNATURE OF DOCTOR SIGNATURE OF PARENT/GUARDIAN
NAME OF THE DOCTOR NAME
RELATIONSHIP
DATE:
DERALAKATTE DATE
PROFORMA
NAME : AGE: SEX: CASE NO:
ADDRESS: D.O.A: HOSPITAL NO:
D.O.D:
HISTORY OF INJURY:
Mechanism of injury
GENERAL EXAMINATION:
LOCAL EXAMINATION:
Inspection:
Palpation:
Measurements:
Movements:
Complications:
INVESTIGATIONS:
Routine Hemogram:
Urine Examination:
X-Ray Examination:
Diagnosis:
Treatment given:
FOLLOW UP: Done at following intervals using the Gartland and Werley scoring system and the Lidstrom scoring system for both groups.
Review at 2 weeks:
Review at 4 weeks:
Review at 6 weeks:
Review at 12 weeks:
Review at 24 weeks:
GARTLAND AND WERLEY SCORING9
Residual deformity Prominent ulnar styloid 1
Residual dorsal tilt 2
Radial deviation of hand 3-3
Subjective evaluation Excellent: No pain, disability or limitation of motion 0
Good: Occassional pain, slight limitation of motion, 2
No disability
Fair: Occassional pain, some limitation of motion, feeling of
Weakness in the wrist, no particular disability if careful,
activities slightly restricted 4
Poor: Pain, limitation of motion, disability, activities more or
less markedly restricted 6
Objective evaluation Loss of dorsiflexion 5
Loss of ulnar deviation 3
Loss of supination 2
Loss of palmar flexion 1
Loss of radial deviation 1
Loss of circumduction 1
Tenderness in distal radioulnar joint 1
Complications Arthritic change
Minimal 1
Minimal with pain 3
Moderate 2
Moderate with pain 4
Severe 3
Severe with pain 5
Nerve complications 1-3
Poor finger function due to cast 1-3
RESULT: 0-2 Excellent
3-8 Good
9-20 Fair
More than 20 Poor
The objective evaluation is based upon the following ranges of motion as being the minimum for normal function :
Dorsiflexion 450,palmar flexion 300,radial deviation 150,ulnar deviation 150,pronation 500,supination 500
LIDSTROM SCORING8
Using the anteroposterior and lateral plain radiographs of the affected and the opposite wrist.
Excellent
If no or insignificant deformity:
-dorsal angulation not exceeding 0o (neutral)
-radial shortening less than 3 mm
-loss of radial inclination not exceeding 4o
Good
Slight deformity:
-dorsal angulation 1-100
-Radial shortening 3-6 mm
-loss of radial inclination 5-90
Fair
Moderate deformity:
-dorsal angulation11-140
-radial shortening 7-11mm
-los of radial inclination 10-140
Poor
Severe deformity:
-dorsal angulation exceeding 150
-radial shortening of atleast 12mm
-loss of radial inclination more than 150