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CTRI Number  CTRI/2024/05/067344 [Registered on: 14/05/2024] Trial Registered Prospectively
Last Modified On: 10/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Stem Cell Therapy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of recovery between allogenic Wharton Jelly derived Stem cells versus Platelet Rich Plasma in patients undergoing hip arthroplasty for fracture neck of femur– A Pilot Prospective Randomised Double-Blinded Study 
Scientific Title of Study   A Pilot Prospective Randomized Controlled Trial to compare recovery following hip fracture arthroplasty using allogenic Wharton Jelly derived Stem cells versus Platelet Rich Plasma – Double-Blinded Study 
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. SAHIL BATRA 
Designation  ASSISTANT PROFESSOR 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES 
Address  ROOM NO 733, NATIONAL CENTRE FOR AGEING, AIIMS, NEW DELHI

South
DELHI
110029
India 
Phone  9899816498  
Fax    
Email  sahilbatra25@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR. SAHIL BATRA 
Designation  ASSISTANT PROFESSOR 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES 
Address  ROOM NO 733, NATIONAL CENTRE FOR AGEING, AIIMS, NEW DELHI

South
DELHI
110029
India 
Phone  9899816498  
Fax    
Email  sahilbatra25@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR. SAHIL BATRA 
Designation  ASSISTANT PROFESSOR 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES 
Address  ROOM NO 733, NATIONAL CENTRE FOR AGEING, AIIMS, NEW DELHI

South
DELHI
110029
India 
Phone  9899816498  
Fax    
Email  sahilbatra25@gmail.com  
 
Source of Monetary or Material Support  
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI 
 
Primary Sponsor  
Name  RESEARCH SECTION ALL INDIA INSTITUTE OF MEDICAL SCIENCES 
Address  ANSARI NAGAR, AIIMS, NEW DELHI 
Type of Sponsor  Research institution and hospital 
 
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 SAHIL BATRA  ALL INDIA INSTITUTE OF MEDICAL SCIENCES  ROOM NO 733, NATIONAL CENTRE FOR AGEING, ANSARI NAGAR
South
DELHI 
9899816498

sahilbatra25@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M849||Disorder of continuity of bone, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Allogenic Wharton Jelly derived Stem cells  Patients undergoing hip arthroplasty either Total Hip Arthroplasty or Bipolar Arthroplasty for Fracture neck of femur with posterior approach will be administered with allogenic Wharton jelly derived stem cells injection into the abductors. 
Comparator Agent  Autologous Platelet Rich Plasma  Patients undergoing hip arthroplasty either Total Hip Arthroplasty or Bipolar Arthro-plasty for Fracture neck of femurF with posterior approach will be administered with autologous Platelet Rich Plasma injection into the abductors. 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  NA 
 
ExclusionCriteria 
Details  NA 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The Short Physical Performance Battery (sPPB) at week 26 after injection serves as the primary end- point for evaluating efficacy.  The Short Physical Performance Battery (sPPB) at week 26 after injection serves as the primary end- point for evaluating efficacy. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare Lower Extremities Measure (LEM) and assessment of abduction strength in all the three groups at the end of 26 weeks and 52 weeks and cause of mortality if any at the end of 1 year.  26 weeks and 52 weeks 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   27/05/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - NO
Brief Summary  

Femoral neck fracture (FnF) within the older adult population represents a relevant socio-economic concern. It is associated with a substantially increased risk of death and major morbidity in older adults, with 33% cumulative one-year mortality rates. Post-traumatic and postoperative mobility impairment results in associated adverse events, such as thromboembolism and pneumonia.  Operative treatment of hip fractures is the only viable option in almost all cases in order to facilitate early mobilization, and to reduce the risk of complications associated with immobilization.

Patients treated with arthroplasty have the ability of full weight-bearing immediately after surgery, but nevertheless exhibit poor mobility, low quality of life, and high institutionalization rates. For the frail and often sarcopenic FnF patients, surgery results in a significant stress reaction as well as iatrogenic injury to the periarticular musculature of the hip.

Consequently, a high unmet clinical need exists to improve recovery following FnF surgery to enable the older adult patient cohort to regain physical function and return to activities of daily life. We therefore propose a randomized controlled trial of an intervention designed to enhance muscle performance and hence improve mobilization.

Therefore, the purpose of this study is to perform a Randomized Controlled Trial in order to determine efficacy, safety and tolerability of allogenic Wharton Jelly derived Stem cells in comparison with Platelet rich plasma (PRP).

 
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