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CTRI Number  CTRI/2024/07/071162 [Registered on: 23/07/2024] Trial Registered Prospectively
Last Modified On: 22/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   which is better approach in management of Femoral neck fracture through Hemiarthroplasty in elderly patient through Posterior or Direct Lateral approach  
Scientific Title of Study   Direct Lateral (Modified Hardinge) Versus Posterior (Moore) approach for hemiarthroplasty for femoral neck fracture in elderly in terms of outcomes and complications : A Randomized Controlled Trial 
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 Lakshit Suthar 
Designation  JUNIOIR RESIDENT  
Affiliation  DR. S. N. MEDICAL COLLEGE JODHPUR 
Address  Room no. 2, Orthopaedic OPD, Gate No. 10, Department of orthopaedics, M.G.H. , olympic circle, Jodhpur

Jodhpur
RAJASTHAN
342001
India 
Phone  8290712033  
Fax    
Email  dr.lakshitsuthar98@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR MAHESH BHATI 
Designation  SENIOR PROFESSOR  
Affiliation  DR. S. N. MEDICAL COLLEGE JODHPUR 
Address  Room no. 1, Orthopaedic OPD, Gate No. 10, Department of orthopaedics, M.G.H. , olympic circle, Jodhpur

Jodhpur
RAJASTHAN
342008
India 
Phone  9414127648  
Fax    
Email  drmbhati5090@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR MAHESH BHATI 
Designation  SENIOR PROFESSOR  
Affiliation  DR. S. N. MEDICAL COLLEGE JODHPUR 
Address  Room no. 1, Orthopaedic OPD, Gate No. 10, Department of orthopaedics, M.G.H. , olympic circle, Jodhpur

Jodhpur
RAJASTHAN
342008
India 
Phone  9414127648  
Fax    
Email  drmbhati5090@gmail.com  
 
Source of Monetary or Material Support  
DR. S. N. MEDICAL COLLEGE, Residency road, Shastri nagar,Jodhpur, Rajasthan, 342003 
 
Primary Sponsor  
Name  LAKSHIT SUTHAR 
Address  Room no. 2, Orthopaedic OPD, Gate No. 10, Department of orthopaedics, M.G.H. , olympic circle, Jodhpur 
Type of Sponsor  Other [SELF] 
 
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 Lakshit Suthar  MGH HOSPITAL  DR. S. N. MEDICAL COLLEGE, Residency road, Shastri nagar,Jodhpur, Rajasthan, 342003
Jodhpur
RAJASTHAN 		 8290712033

dr.lakshitsuthar98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE DR. SAMPURNANAND MEDICAL COLLEGE , JODHPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S720||Fracture of head and neck of femur,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Direct lateral (Modified hardinge)  Hemireplacement arthroplasty will be done by Direct Lateral(Modified Hardinge) approach in which Gluteus medius with Vastus lateralis muscle is lifted from femur and joint capsulotomy done. 
Comparator Agent  Posterior (Moore)  Hemireplacement arthroplasty will be done by Posterior (Moore) approach in which Pyriformis with other external rotator of hip muscle are lifted from femur and joint capsulotomy done. 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  80.00 Year(s)
Gender  Male 
Details  Patient with more than or equel to 60 years of age 
 
ExclusionCriteria 
Details  Pre - existing severe degenerative joint disease

Pre - existing arthritis of the fractured hip

Any severe neurological / cognitive impairement

Any patient with previous history of hip sepsis and hip surgery

Pathological fracture neck of femur
Fracture involving other extremitity / spine / pelvis or multiple organ system injury

Patient / relative refused for consent  
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the proportion of patient with post operative dislocation between Direct Lateral (Modified Hardinge) and Posterior (Moore) approach groups.  6 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
1.To compare the mean Modified Harris Hip score (HHS) between Direct Lateral (Modified Hardinge) & Posterior (Moore) approaches at 2 week, 1 month , 3 month & 6 month follow up.

2.To compare both the groups on the basis of surgical duration , blood loss , perioperative blood transfusion , postoperative pain.

3.To compare both the groups in terms of complications (Infection, Periprosthetic fracture, Limb length discrepancies & Abductor lurch). 		 6 MONTHS 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
Final Enrollment numbers achieved (Total)= "160"
Final Enrollment numbers achieved (India)="160" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   03/08/2024 
Date of Study Completion (India) 15/07/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 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-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 [DR.LAKSHITSUTHAR98@GMAILCOM].

  6. For how long will this data be available start date provided 31-12-2023 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   Femoral Neck fracture is very common in geriatric population. This study will further inhance our knowledge regarding management of this patient to decrease adverse event. 
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