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CTRI Number  CTRI/2020/05/025480 [Registered on: 29/05/2020] Trial Registered Prospectively
Last Modified On: 27/05/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   Accuracy assessment of deformity correction using computer guided newer generation external fixator in deformities of thigh and leg bones  
Scientific Title of Study   Evaluation of accuracy of bony alignment using computer assisted hexapod fixator in correction of long bone deformities of lower limb 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anubhav Vichitra 
Designation  PG resident MS Orthopaedics  
Affiliation  Maulana Azad Medical College 
Address  Department of Orthopaedics, Maulana Azad Medical College, Delhi,Bahadur Shah Zafar Marg, Delhi

Central
DELHI
110002
India 
Phone  9654737879  
Fax    
Email  anu.thundercharge@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vinod Kumar 
Designation  Director Professor, Department of Orthopaedics, LNH 
Affiliation  Lok Nayak Hospital 
Address  Lok Nayak Hospital,Jawaharlal Nehru Marg, Delhi Gate,Delhi

Central
DELHI
110002
India 
Phone  9654737879  
Fax    
Email  drvk706@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vinod Kumar 
Designation  Director Professor, Department of Orthopaedics, LNH 
Affiliation  Lok Nayak Hospital 
Address  Lok Nayak Hospital,Jawaharlal Nehru Marg, Delhi Gate,Delhi


DELHI
110002
India 
Phone  9654737879  
Fax    
Email  drvk706@gmail.com  
 
Source of Monetary or Material Support  
Maulana Azad Medical College, Bahadur Shah Safar Marg, New Delhi 110002 
 
Primary Sponsor  
Name  Maulana Azad Medical College 
Address  Bahadur Shah Safar Marg, New Delhi 110002 
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 
Anubhav Vichitra   Lok Nayak Hospital  Jawaharlal Nehru Marg, Delhi Gate, New Delhi, 110002
Central
DELHI 		 9654737879

anu.thundercharge@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional EthicsCommittee, MaulanaAzad Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Computer assisted hexapod fixator   Correction of long bone deformities of lower limb using computer assisted hexapod fixator  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Clinico-radiologically diagnosed cases of lower limb deformities requiring treatment by Ilizarov method
2.Ilizarov fixator treated lower limb deformity cases with residual deformity after intra-operative acute correction manoeuvre
 
 
ExclusionCriteria 
Details 
1.Ilizarov fixator treated lower limb deformity cases where acceptable bony alignment could be achieved intra-operatively
2.Injuries on ipsilateral limb requiring vascular repair  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Accuracy of deformity correction will be assessed by following :

A. Residual Angulation at CORA
B. Reference line and angles
C. Value of residual torsional component of deformity, determined clinically
D. Residual Limb length discrepancy (LLD)

Opposite side alignment values will be considered as normal reference values. In case opposite side is also involved, standard reference values will be considered as normal values for evaluation purpose.
 		 Primary outcomes will be assessed at two timepoints –
1. Immediately after application of computer assisted hexapod external fixator in postoperative period
2. After completion of software prescribed correction manoeuvre  
 
Secondary Outcome  
Outcome  TimePoints 
A. Manner’s grading of deformity (for accuracy assessment)2
B. Time period of Deformity correction
C. Difficulty, Problems and Complications, if any
 		 Secondary outcomes will be measured at following timepoint
1. After removal of computer guided external fixator frame
 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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)   01/06/2020 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This study has been designed as a prospective interventional study to evaluate the accuracy of bony alignment using computer assisted hexapod fixator in correction of long bone deformities of lower limb in patients of age group of 18-60 years. Study will be conducted in India for a duration of 1 year. Outcome of the study will be assessed by residual angulation at CORA, reference lines and angles, residual LLD, time period of deformity correction, number of correction manoeuvres required. 
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