| CTRI Number |
CTRI/2022/05/042778 [Registered on: 24/05/2022] Trial Registered Prospectively |
| Last Modified On: |
09/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
effectiveness of autologous platelet rich plasma intra articular injection in knee pain |
|
Scientific Title of Study
|
Study of Efficacy of Intra-articular Injection of Autologous Platelet Rich Plasma in Patients with Grade 2 Osteoarthritis Knee |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR KALYAANASUNDHARY S |
| Designation |
JUNIOR RESIDENT ACADEMIC PMR |
| Affiliation |
AIIMS BHOPAL |
| Address |
Room number 1, department of PMR,AIIMS BHOPAL
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9655185996 |
| Fax |
|
| Email |
kalyaanasundharys.pg2021@aiimsbhopal.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DR CHETHAN C |
| Designation |
ASSOSCIATE PROFESSOR |
| Affiliation |
AIIMS BHOPAL |
| Address |
ROOM NUMBER 5, DEPARTMENT OF PMR AIIMS BHOPAL SAKET NAGAR BHOPAL
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9711306545 |
| Fax |
|
| Email |
chethan.veera@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR KALYAANASUNDHARY S |
| Designation |
JUNIOR RESIDENT ACADEMIC PMR |
| Affiliation |
AIIMS BHOPAL |
| Address |
ROOM NUMBER 604, GIRLS PG HOSTEL AIIMS BHOPAL, SAKET NAGAR BHOPAL
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9655185996 |
| Fax |
|
| Email |
kalyaanasundharys.pg2021@aiimsbhopal.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ICMR PG THESIS GRANT |
| Address |
ICMR |
| Type of Sponsor |
Government funding agency |
|
|
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 KALYAANASUNDHARY S |
AIIMS BHOPAL |
ROOM NUMBER 1
DEPARTMENT OF PMR
Bhopal
MADHYA PRADESH |
9655185996
kalyaanasundharys.pg2021@aiimsbhopal.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS BHOPAL- INSTITUTIONAL HUMAN ETHICS COMMITTEE-POSTGRADUATE RESEARCH (IHEC-PGR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
KELLGREN LAWRENCE GRADE 2
CHRONIC KNEE PAIN FOR MORE THAN 3 MONTHS DURATION.
PATIENTS WITH PRIMARY OSTEOARTHRITIS |
|
| ExclusionCriteria |
| Details |
ACUTE SIGNIFICANT TRAUMA
PATIENTS WITH DIABETES MELLITUS
ANY INTRA ARTICULAR INJECTION IN LAST 6 MONTHS
PATIENTS WITH BLEEDING DISORDER
PATIENTS WITH SECONDARY OSTEOARTHRITIS
UNWILLINGNESS TO PARTICIPATE IN STUDY |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
EFFICACY OF PAIN RELIEF
ASSESS THE CARTILAGE THICKNESS |
EFFICACY OF PAIN RELIEF0.1.3 AND 6 MONTHS
ASSESS THE CARTILAGE THICKNESS-0 AND 6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ASSESS FUNCTIONAL OUTCOME |
AT 0,1,3 AND 6 MONTHS |
|
|
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)
|
26/05/2022 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
TO BE PUBLISHED AFTER COMPLETION |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
TO STUDY THE EFFICACY OF INTRA ARTICULAR INJECTION OF AUTOLOGOUS PLATELET RICH PLASMA IN PATIENTS WITH GRADE 2 OSTEOARTHRITIS KNEE AND TO ASSESS THE IMPROVENT IN PAIN RELIEF , FUNCTIONAL OUTCOME AND CARTILAGE THICKNESS. |