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CTRI Number  CTRI/2026/01/100080 [Registered on: 01/01/2026] Trial Registered Prospectively
Last Modified On: 01/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   A study to evaluate use of ankle sparing fixator for management of calcaneum fractures  
Scientific Title of Study   Evaluation of clinico-radiological outcomes of minimally invasive Ilizarov frame fixation in calcaneal fractures: a prospective cohort study 
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 Jitendra Wadhwani 
Designation  Associate Professor  
Affiliation  Pt B D S PGIMS, Rohtak, Haryana, India. PIN:124001 Department of Orthopaedics, Pt B D S PGIMS Rohtak 
Address  Pt B D S PGIMS, Rohtak, Haryana, India. PIN:124001 Department of Orthopaedics, Pt B D S PGIMS Rohtak, Haryana, India. PIN 124001 Rohtak HARYANA 124001 India Phone 9812337494

Rohtak
HARYANA
124001
India 
Phone  9812337494  
Fax    
Email  drjitendra28.03@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jitendra Wadhwani 
Designation  Associate Professor  
Affiliation  Pt B D S PGIMS, Rohtak, Haryana, India. PIN:124001 Department of Orthopaedics, Pt B D S PGIMS Rohtak 
Address  Pt B D S PGIMS, Rohtak, Haryana, India. PIN:124001 Department of Orthopaedics, Pt B D S PGIMS Rohtak, Haryana, India. PIN 124001 Rohtak HARYANA 124001 India Phone 9812337494

Rohtak
HARYANA
124001
India 
Phone  9812337494  
Fax    
Email  drjitendra28.03@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nikhil Yadav 
Designation  Junior Resident 
Affiliation  Pt B D S PGIMS, Rohtak, Haryana, India 
Address  Pt B D S PGIMS, Rohtak, Haryana, India. PIN:124001 Department of Orthopaedics, Pt B D S PGIMS Rohtak, Haryana, India. PIN 124001 Rohtak

Rohtak
HARYANA
124001
India 
Phone  8572854661  
Fax    
Email  drnikhilyaduvanshi@gmail.com  
 
Source of Monetary or Material Support  
Government medical college (Pt BD sharma PGIMS rohtak ) 
 
Primary Sponsor  
Name  Pt B.D Sharma PGIMS rohtak 
Address  Department of Orthopaedics ,Pt BDS PGIMS ,Rohtak , Haryana ,INDIA 124001 
Type of Sponsor  Government medical college 
 
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 Nikhil Yadav  Pt.B.D.Sharma PGIMS  Department of Orthopaedics, Pt.B.D Sharma PGIMS Rohtak, HARYANA, India.
Rohtak
HARYANA 		 8572854661

drnikhilyaduvanshi@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 
Healthy Human Volunteers  healthy human volunteers having calcaneal fracture  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Patients aged 18-50 years
2. All the post traumatic Displaced Intra-Articular Calcaneal Fractures(DIACF) with Sanders type II,III and IV  
 
ExclusionCriteria 
Details  1. Pathological fractures.
2. Sanders type I fracture.
3. Age less than 18yrs and greater than 50yrs.
4. Severe comorbidities (e.g., uncontrolled diabetes, peripheral vascular disease etc.).
5. Patients unwilling to participate
• Extra-articular fracture of calcaneum.
• Any neurological deficit in fractured lower limb.
• Any other concomitant fracture in the same limb  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
FFI (Foot Functional Index)  2 WEEKS
1 MONTH
2 MONTHS
3 MONTHS
4 MONTHS
5 MONTHS
6 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
1. Radiological outcomes (eg:- Bohler angle, Gissane angle, Calcaneal height etc.)
2. Complications if any 		 2 WEEKS
1 MONTH
2 MONTHS
3 MONTHS
4 MONTHS
5 MONTHS
6 MONTHS  
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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   N/A 
Date of First Enrollment (India)   15/01/2026 
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="0"
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  
Calcaneal fractures are complex injuries often associated with significant soft-tissue compromise and long-term functional impairment. Conventional open reduction and internal fixation, though effective in restoring anatomy, is frequently associated with wound complications. Minimally invasive fixation using the Ilizarov external fixator offers stable fracture fixation with minimal soft-tissue disruption and allows early mobilization.

This prospective cohort study aims to evaluate the clinical and radiological outcomes of minimally invasive Ilizarov frame fixation in patients with calcaneal fractures. Patients will be followed at regular intervals and assessed for functional recovery using validated clinical scoring systems, radiological restoration of calcaneal anatomy, time to union, and procedure-related complications.

The study seeks to determine whether Ilizarov frame fixation provides satisfactory functional outcomes with acceptable radiological alignment and a low complication rate, thereby establishing it as a reliable alternative to conventional surgical methods in the management of calcaneal fractures.
  
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