| CTRI Number |
CTRI/2025/04/084739 [Registered on: 15/04/2025] Trial Registered Prospectively |
| Last Modified On: |
13/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
interventional study comparing the outcome of administering combined intraarticular and intraosseous Platelet Rich Plasma for one set of participants against intraarticular Platelet Rich Plasma injection alone in another set of participants in early knee osteoarthritis |
|
Scientific Title of Study
|
Evaluating combined intraarticular and intraosseous PRP Vs intraarticular PRP injection in early knee osteoarthritis. |
| 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 Ankit Dadra |
| Designation |
Associate Professor, Department of Orthopaedics |
| Affiliation |
Post graduate Institute of Medical Education and Research |
| Address |
Post graduate Institute of Medical Education and Research
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9888648830 |
| Fax |
|
| Email |
ankitdadra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankit Dadra |
| Designation |
Associate Professor, Department of Orthopaedics |
| Affiliation |
Post graduate Institute of Medical Education and Research |
| Address |
Post graduate Institute of Medical Education and Research
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9888648830 |
| Fax |
|
| Email |
ankitdadra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankit Dadra |
| Designation |
Associate professor, Department of orthopaedics |
| Affiliation |
Post graduate Institute of Medical Education and Research |
| Address |
Postgraduate Institute of Medical Education and Research
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9888648830 |
| Fax |
|
| Email |
ankitdadra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post graduate Institute of Medical Education and Research
Sector 12 Chandigarh. 160012. India |
|
|
Primary Sponsor
|
| Name |
Post graduate Institute of Medical Education and Research |
| Address |
Sector 12, Chandigarh 160012 |
| 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 Ajay jose |
PGIMER Chandigarh |
Department of Orthopaedics
Chandigarh
CHANDIGARH |
9535943641
ajayjose963@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee (Intramural) |
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
|
| Type |
Name |
Details |
| Intervention |
Combined intra-articular and intraosseous PRP in early knee osteoarthritis |
PRP will be injected both intraarticularly (8ml for one knee joint) and in intraosseous route (5ml in tibial plateau and 5ml in medial femoral condyle) |
| Comparator Agent |
Intraarticular PRP injection in early osteoarthritis of knee |
8ml prp will be injected in intra-articular route alone in one knee |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients from age of 35 to 70 |
|
| ExclusionCriteria |
| Details |
Secondary osteoarthritis.
Immunocompromised status or uncontrolled diabetes.
Symptomatic OA affecting joints other than the knee.
Recent intra-articular steroid or hyaluronic acid injections in the knee joint.
Anticoagulation therapy.
Active or previous infections. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of improvements in clinical VAS score, radiological parameters, and functional outcomes using WOMAC and KOOS scores |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To look for any adverse effects due to combined intra-osseous and intra-articular PRP injection in early OA knee (fever, pain, allergic reactions etc). |
6 months |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/05/2025 |
| 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="1"
Months="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Patients presenting with symptoms of early osteoarthritis of knee in PGIMER OPD will be evaluated for the study after clinical and radiological examination. Those who are in the inclusion criteria will be recruited under one of the two groups which include combined intraarticular with intraosseous PRP and intraarticular PRP alone in randomized manner.
Clinical outcome will be evaluated by questionnaire follow up in 1st, 3rd and 6th month for each sample. The aim of the study is to evaluate whether there is any significant difference in the clinical outcome between the two groups of patients |