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CTRI Number  CTRI/2024/10/075337 [Registered on: 15/10/2024] Trial Registered Prospectively
Last Modified On: 29/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Heel fracture treated by plating by 2 different approaches  
Scientific Title of Study   Functional outcome in sinus tarsi approach vs conventional approach in Calcaneum fracture fixation 
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 Parthkumar Dungrani  
Designation  Resident doctor  
Affiliation  Government medical College bhavnagar  
Address  804 PG 3 sir t hospital bhavnagar

Bhavnagar
GUJARAT
364001
India 
Phone  9879116206  
Fax    
Email  parthkumardungrani@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Parthkumar Dungrani  
Designation  Resident doctor  
Affiliation  Government medical College bhavnagar  
Address  804 PG 3 sir t hospital bhavnagar

Bhavnagar
GUJARAT
364001
India 
Phone  9879116206  
Fax    
Email  parthkumardungrani@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Parthkumar Dungrani  
Designation  Resident doctor  
Affiliation  Government medical College bhavnagar  
Address  804 PG 3 sir t hospital bhavnagar

Bhavnagar
GUJARAT
364001
India 
Phone  9879116206  
Fax    
Email  parthkumardungrani@gmail.com  
 
Source of Monetary or Material Support  
Sir t hospital panwadi bhavnagar Gujarat PIN 364001 
 
Primary Sponsor  
Name  Dr Parthkumar Dungrani  
Address  804 PG 1 sir t hospital bhavnagar  
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 Parthkumar Dungrani   Sir t hospital bhavnagar   Sir t hospital panwadi bhavnagar
Bhavnagar
GUJARAT 		 9879116206

parthkumardungrani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee government medical College bhavnagar   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M95||Other acquired deformities of musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Day(s)
Age To  70.00 Day(s)
Gender  Both 
Details  All patients of age 18 and above  
 
ExclusionCriteria 
Details  Pregnant Female

Patient Who Had Gone Previous Operative Management
Calcaneum open fracture
uncontrolled diabetic
Peripheral vascular disease patient
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Functional and radiological outcome  15 month 
 
Secondary Outcome  
Outcome  TimePoints 
AOFAS score  15 months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   23/10/2024 
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 Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response - None of the above

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [parthkumardungrani@gmail.com].

  6. For how long will this data be available start date provided 01-08-2025 and end date provided 31-12-2028?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   EC committee approval will be taken .written informed consent will be taken after detail explanation of study to the participants.Pre op AOFAS score and Radiological parameter will be taken at ortho Ward.Follow up of patient will be done at 15 days 1.5 month and 3 month and 6 month and data regarding AOFAS score and radiological parameter will be taken during all follow up visit. Data analysis will be done.  
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