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CTRI Number  CTRI/2024/01/061122 [Registered on: 04/01/2024] Trial Registered Prospectively
Last Modified On: 03/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To Compare Functional Outcomes Between Half Hip Joint Replacement and Internal Fixation in Patients with Hip Surgeries. 
Scientific Title of Study   Comparison of Functional Outcomes between Hip Hemiarthroplasty and Internal Fixation in Patients with 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  Poonam Yadav 
Designation  1st MPT 
Affiliation  College of Physiotherapy Sumandeep Vidyapeeth deemed to be University 
Address  College of physiotherapy, Sumandeep Vidyapeeth deemed to be University ,Piparia, Waghodia,Vadodara-391760

Vadodara
GUJARAT
391760
India 
Phone  6354376434  
Fax    
Email  yp92328@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Niketa Patel 
Designation  Associate Professor 
Affiliation  College of Physiotherapy Sumandeep Vidyapeeth deemed to be University 
Address  College of physiotherapy, Sumandeep Vidyapeeth deemed to be University ,Piparia, Waghodia,Vadodara-391760.

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  College of Physiotherapy Sumandeep Vidyapeeth deemed to be University 
Address  College of physiotherapy, Sumandeep Vidyapeeth deemed to be University ,Piparia, Waghodia,Vadodara-391760.

Vadodara
GUJARAT
391760
India 
Phone  9099774190  
Fax    
Email  niketa.cop@sumandeepvidyapeethdu.edu.in  
 
Source of Monetary or Material Support  
Poonam Yadav- It is a self funded study and the materials will be bought by me. 
 
Primary Sponsor  
Name  Poonam Yadav 
Address  College of Physiotherapy, Sumandeep Vidyapeeth Deemed to be University, Piparia Waghodia, Vadodara, Gujarat-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 
Poonam Yadav  Dhiraj General Hospital  Sumandeep Vidyapeeth Compound, Piparia, Waghodia, Vadodara, Gujarat-391760
Vadodara
GUJARAT 		 6354376434

yp92328@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 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  The patients between age of 18 to 70 years who are treated with Hip Hemi arthroplasty at 6 weeks post-surgery and Patients operated with Dynamic Hip Screw and Proximal femoral nail for hip fracture at 6 weeks post-surgery including Both the genders. 
 
ExclusionCriteria 
Details  Patients who have revision surgeries for hip joint.
Bilateral involvement of the hip joint, Any neurological or musculoskeletal conditions that affect the outcome measures, Unwillingness to participate in the study are excluded. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Hip Abductor Muscle Strength using sphygmomanometer

 		 6 week 
 
Secondary Outcome  
Outcome  TimePoints 
Modified Harris hip score  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)="46" 
Phase of Trial   N/A 
Date of First Enrollment (India)   06/01/2024 
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)
Modification(s)  		 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   This is an Observational Study(Cross-sectional). There are many studies which have compared assessed the functional outcomes in patients with hip surgeries. But we have not found any study which compares the functional outcomes at 6 weeks post hip surgeries. Hence, we determined to compare the functional outcomes at 6 weeks post-surgery between Hip hemiarthroplasty and internal fixation surgeries. The patients with hip surgery that are coming at 6 weeks to the Orthopedic OPD for follow up 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 signing the consent, the participant information sheet will be given to them. Subjects will be screened and assessed and those fulfilling the inclusion and exclusion criteria will be recruited for the study. After this, the participant’s hip abductor strength will be assessed using sphygmomanometer both operated and sound limb. The strength will be measured 3 times for each limb and the average of the 3 trials will be considered. Following this, the modified Harris hip score will be administered to assess the functional outcome of the participants. The data will be statistically analyzed. 
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