| 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
|
|
|
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
|
|
|
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 |
|
|
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). |