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CTRI Number  CTRI/2024/01/062137 [Registered on: 31/01/2024] Trial Registered Prospectively
Last Modified On: 10/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Study to determine the status of function patients managed with and without operation for Calcaneum fracture  
Scientific Title of Study   Comparative study to evaluate functional outcomes in calcaneal fractures managed by conservative versus operative methods. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shubham Verma  
Designation  Post Graduate Junior Resident Orthopaedics  
Affiliation  Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences ,Rohtak 
Address  Dr Shubham Verma, Post Graduate Junior Resident, Orthopaedics, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences ,ROHTAK

Rohtak
HARYANA
124001
India 
Phone  7015801954  
Fax    
Email  svshubham04@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pradeep Kamboj  
Designation  Senior Professor Orthopaedics Pgims Rohtak 
Affiliation  Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences ,Rohatak 
Address  Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Rohtak, Haryana, 124001

Rohtak
HARYANA
124001
India 
Phone  9992014147  
Fax    
Email  kambojdr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pradeep Kamboj  
Designation  Senior Professor Orthopaedics Pgims Rohtak 
Affiliation  Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences ,Rohatak 
Address  Department of Orthopaedics , Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences ,Rohtak, Haryana, 124001

Rohtak
HARYANA
124001
India 
Phone  9992014147  
Fax    
Email  kambojdr@gmail.com  
 
Source of Monetary or Material Support  
Department of Orthopaedics, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Rohtak, Haryana, 124001, India 
 
Primary Sponsor  
Name  Dr Shubham Verma 
Address  Pgims Rohtak, Haryana 124001 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pradeep Kamboj   Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences  Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences , Rohtak, Haryana, 124001
Rohtak
HARYANA 
9992014147

kambojdr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical Research Ethics Committee Pt. B. D. Sharma PGIMS/UHS, Rohtak  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S920||Fracture of calcaneus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Cast  Cast Application  
Intervention  Plating or Kwiring or screw fixation or Essex Lopresti   Using any of the operative techniques  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  All patients of 18 to 70 years of age, with calcaneal fractures requiring surgery (Sander’s
Grade II, III, IV)less than 3 weeks old having normal bipedal gait prior to fracture will be
included in the study. 
 
ExclusionCriteria 
Details  Calcaneal fractures with associated spinal injuries, peripheral vasculopathies, pathological
fractures and patients not giving consent will be excluded from our study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Based on Aofas Score : Pain (40 points), Function
(50 points) , Alignment (10 points) and Modified Rowe Score : Pain (30 points) , Range of motion (20 points) , Gait (15 points) , Activities (20 points) , Work (15 points) 
6 Months 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   03/02/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Calcaneus is a complex shaped bone in foot, consisting of a tuberosity, an anterior
process, and a medial process known as the sustentaculum tali. It articulates with talus via the
subtalar joint, which comprises a large posterior facet, a medial facet on the sustentaculum
and a small anterior facet. It articulates with cuboid forming calcaneocuboid joint.
Calcaneal fractures account for approximately 2% of all fractures, with displaced
intra- articular fractures comprising 60% to 75% of these injuries. Of patients with calcaneal
fractures, 10% have associated spine fractures and 26% are associated with other extremity
injuries1. Most fractures of the calcaneus are typically the result of high-energy trauma, such
as a fall from a height or a motor vehicle accident. The clinical examination focuses on pain,
swelling, hematoma and deformity at the hindfoot. Active or passive inversion and eversion
of the foot are painful. The initial radiographic evaluation of the patient with a suspected
calcaneal fracture includes a lateral radiograph series. The lateral radiograph of the hindfoot
demonstrates two important angles: the tuber angle of Böhler and the crucial angle of
Gissane2. CT scanning has vastly improved the understanding of calcaneal fractures. CT
images are obtained in the axial, 30-degree semi-coronal, and sagittal planes. The coronal
views provide information about the articular surface of the posterior facet, the
sustentaculum, the overall shape of the heel, and the position of the peroneal and flexor
hallucis tendons. The articular fracture classification system of Sanders et al. is based on
images in the coronal plane

There is a broad consensus that the outcome of calcaneal fractures mainly is
determined by the degree of joint destruction at the time of injury. However, until recently,
limitations of radiologically obtainable information and the lack of a useful classification
system have prevented knowledgeable assessment, understanding, and comparison of fracture
patterns of the os calcis.
The most common classification system used for more than 3 decades was proposed
in 1952 by Essex-Lopresti. This classification was developed to describe intra-articular and
extra-articular fractures of the calcaneus. The extra-articular fractures may involve anterior
process, tuberosity, achilles tendon avulsion, and sustentacular fractures. The intra-articular
calcaneal fractures will be divided into two groups: tongue-type and joint depression-type
fractures. The simplicity of this classification led to its widespread use. A major disadvantage
of this classification system exists in that the joint depression-type fracture group comprises
too many different fracture patterns. This does not allow for a useful correlation between the
fracture classification and the ultimate clinical outcome

The introduction of CT was the turning point in the classification and treatment of
calcaneal fractures. Axial and coronal CT views of calcaneal fractures changed the focus
away from the Böhler angle and the undefinable joint destruction to the specific analysis of
the posterior facet and the calcaneocuboid joint.
Sanders et al. developed a classification system which divided the posterior facet into
three different columns. The fractures were subdivided according to the location of the
primary and additional fracture lines

Fractures of the calcaneus remain among the most challenging for the orthopaedic
surgeon. Nonoperative treatment consists of a supportive splint to allow dissipation of the
initial fracture hematoma, followed by conversion to a prefabricated fracture boot with the
ankle locked in neutral flexion to prevent an equinus contracture and an elastic compression
stocking-to-minimize dependent oedema. Early subtalar and ankle joint range-of-motion
exercises are initiated, and non-weight-bearing restrictions are maintained for approximately
10 to 12 weeks until the radiographic union is confirmed5
.
The majority of displaced, intra-articular fractures of the calcaneus can be effectively
treated via an Extensile lateral approach. For internal fixation most surgeons use a single
lateral plate that displays the anatomical features of the calcaneus, providing support to the
tuberosity, the thalamic portion with the posterior joint facet and the anterior process. Screw
placement within the plate can be facilitated with the use of polyaxial locking plate designs6
.
The options for treating intraarticular calcaneus fractures may be evaluated in four
groups : Conservative treatment, closed reduction percutaneous fixation, open reduction
internal fixation and primary subtalar arthrodesis, and mini open approaches with
percutaneous fixation

In cases of simple intra articular fractures (Type IIa as described by Sanders et al.)
with minor displacement (≤2 mm) of the posterior facet intra articular fracture, a successful
reduction is attainable with the semi open technique using small portals (small elevator via
stab incisions) and percutaneous fixation. In elderly patients with concomitant diseases and
soft tissue problems, operative options that are more appropriate than the use of extensile
surgery where the potential wound complications could be significant. Severe vascular
diseases, advanced diabetes, and a preinjury non ambulatory status are contraindications for
open reduction and internal fixation. In cases of severe comminution of the posterior facet
(Type IV of the classification described by Sanders et al.), an anatomic reduction of the joint
surface rarely is obtainable. In this situation, two options are applicable according to the skill
and experience of the surgeon: semi open reduction and percutaneous fixation to restore the
anatomic axis; or primary subtalar fusion, which requires extensile bone grafting from the
iliac crest

In view of the above available modalities of treatment and since no method is
declared ideal in literature and also as many times patients do not give consent for operative intervention, we would like to conduct a study comparing conservative and operative approach for management of calcaneal fractures.
 
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