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CTRI Number  CTRI/2024/02/062898 [Registered on: 20/02/2024] Trial Registered Prospectively
Last Modified On: 19/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To Compare Functional Outcome of Total Hip Joint Replacement and Half-hip joint replacement for Patients After Traumatic Hip Surgery. 
Scientific Title of Study   Comparison of Functional Outcomes between Hip Hemiarthroplasty and Total Hip Arthroplasty in Patients with Traumatic Hip Surgeries. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Janvi Shah 
Designation  1st Year MPT 
Affiliation  Sumandeep Vidyapeeth Deemed to be University 
Address  College of Physiotherapy, Sumandeep Vidyapeeth Deemed to be University,Waghodia,Vadodara

Vadodara
GUJARAT
391760
India 
Phone  9082106480  
Fax    
Email  physio.janvi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Niketa Patel 
Designation  Associate Professor 
Affiliation  Sumandeep Vidyapeeth Deemed to be University 
Address  College of Physiotherapy, Sumandeep Vidyapeeth Deemed to be University,Waghodia,Vadodara

Vadodara
GUJARAT
391760
India 
Phone  9099774190  
Fax    
Email  niketa.cop@sumandeepvidyapeethdu.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Niketa Patel 
Designation  Associate Professor 
Affiliation  Sumandeep Vidyapeeth Deemed to be University 
Address  College of Physiotherapy, Sumandeep Vidyapeeth Deemed to be University,Waghodia,Vadodara

Vadodara
GUJARAT
391760
India 
Phone  9099774190  
Fax    
Email  niketa.cop@sumandeepvidyapeethdu.edu.in  
 
Source of Monetary or Material Support  
Janvi Shah- It is a self funded study and the materials will be bought by me. 
 
Primary Sponsor  
Name  Janvi Shah 
Address  College of Physiotherapy,Sumandeep Vidyapeeth Deemed to be University,Piparia,Waghodia,Vadodara-391760 
Type of Sponsor  Other [Self-funded] 
 
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 
Janvi Shah  Dhiraj Hospital  Dhiraj Hospital, Piparia, Waghodia, Vadodara
Vadodara
GUJARAT 		 9082106480

physio.janvi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumandeep Vidyapeeth Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M966||Fracture of bone following insertion of orthopedic implant, joint prosthesis, or bone plate,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  18-70 Years.

Patients who have undergone Traumatic Hip Hemiarthroplasty and Total Hip Arthroplasty 6 weeks back.

Both the genders.
 
 
ExclusionCriteria 
Details  Patients who have revision surgeries of hip joint.

B/L involvement of the hip joint.

Pathological fractures.

Atraumatic conditions of hip joint.

Any neurological or musculoskeletal conditions that affect the outcome measures.

Unwillingness to participate in the study.  
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Unilateral Stance Time for checking the hip abductor muscle strength.
 		 6 week
 
 
Secondary Outcome  
Outcome  TimePoints 
Modified Harris Hip Score for assessing Functional Outcome.  6 week 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/03/2024 
Date of Study Completion (India) 22/03/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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   Thus is an Observational (Cross-Sectional) Study. Previously, there have been many studies that have assessed hip abductor strength in hip replacement surgeries. But we did not come across a study which compares functional outcomes i.e. unilateral stance Time and MHHS between Total Hip Arthroplasty and Hip Hemiarthroplasty patients at 6 weeks post-surgery. Hence, in this study, we determined to compare functional outcomes between Total Hip Arthroplasty and Hip Hemiarthroplasty patients at 6 weeks post-surgery. The subject with hip hemiarthroplasty and total hip arthroplasty that are coming at 6 weeks to Dhiraj General Hospital will be approached. They will be explained about the study and those who are willing to participate will be requested to sign an informed consent form. After receiving the consent, the participant information sheet will be given to them. The participants will be screened and assessed and those fulfilling the inclusion criteria will be recruited for the study. Following this, the participant will be asked to perform unilateral stance and the time will be noted. This will be followed by administration of Modified Harris Hip score. 
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