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CTRI Number  CTRI/2024/05/067007 [Registered on: 08/05/2024] Trial Registered Prospectively
Last Modified On: 05/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [pre operative planning]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of templating methods in patients undergoing Total Hip Arthroplasty 
Scientific Title of Study   Comparison of preoperative conventional and spinopelvic templating in Total Hip Arthroplasty 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kartikey Dubey 
Designation  JR Orthopaedics 
Affiliation  AIIMS Jodhpur 
Address  Room No. 50, OPD Ground Floor, AIIMS , Jodhpur

Jodhpur
RAJASTHAN
342003
India 
Phone  08127223996  
Fax    
Email  kartikeyd123@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.Abhay Elhence  
Designation  Head of Department 
Affiliation  AIIMS Jodhpur 
Address  Room No. 50 , AIIMS OPD , ground floor,C Block.


RAJASTHAN
342003
India 
Phone  08127223996  
Fax    
Email  abhayelhence@gmail.com  
 
Details of Contact Person
Public Query  
Name  Kartikey Dubey 
Designation  JR Orthopaedics 
Affiliation  AIIMS Jodhpur 
Address  Room No. 50, OPD Ground Floor, AIIMS , Jodhpur
Near roadways bus stand

RAJASTHAN
342005
India 
Phone  08127223996  
Fax    
Email  kartikeyd123@gmail.com  
 
Source of Monetary or Material Support  
AIIMS , Jodhpur, Pin Code- 342005, India 
 
Primary Sponsor  
Name  AIIMS Jodhpur 
Address  Room No. 50, OPD Ground Floor, AIIMS , Jodhpur 
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 
DrKartikey Dubey  All India Institute of Medical Sciences Jodhpur  3rd floor, Bblock and C block AIIIMS (Jodhpur)
Jodhpur
RAJASTHAN 		 8127223996

kartikeyd123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M169||Osteoarthritis of hip, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional templating  AP radiographs of pelvis with both hip taken and used to calculate and determine size of implant 
Intervention  spino-pelvic templating  Newer modality of pre operative planning- Lateral radiographs of pelvis with spine will be taken pre-operatively to assess stability and determine the position of implant placement.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Nil 
 
ExclusionCriteria 
Details  1. Patients with post traumatic, dysplastic hips undergoing THA

2. Patients undergoing Revision THA

3. Patients not giving consent
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To determine acetabular and femoral component placement  1st Day and 6th Month 
 
Secondary Outcome  
Outcome  TimePoints 
1. To determine the Patient reported outcome measures (PROMs) at follow up
2. To determine Survivorship using Kaplan meier graph
 		 6th Month 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   16/05/2024 
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)   Open to Recruitment 
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 -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  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 - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (h).

  6. For how long will this data be available start date provided 26-01-2024 and end date provided 26-03-2025?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - h
Brief Summary   The Study aims to compare the outcomes while using conventional (AP radiograph) and Lateral radiograph to determine  the implant placement. 
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