| CTRI Number |
CTRI/2024/10/075179 [Registered on: 14/10/2024] Trial Registered Prospectively |
| Last Modified On: |
22/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of intraarticular injections of Platelet Rich Plasma and Platelet Rich Fibrin in patients with early osteoarthritis of knee |
|
Scientific Title of Study
|
A comparative study of clinico-functional outcomes of intraarticular Platelet Rich Plasma and Platelet Rich Fibrin in the management of early osteoarthritis of knee – prospective randomized control 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 Ankit |
| Designation |
Junior Resident |
| Affiliation |
Sri Devaraj Urs Academy of Higher Education and Research |
| Address |
Room no:6, Department of Orthopedics, RL Jalappa Hospital, Sri Devaraj Urs Academy of Higher Education and Research
Kolar KARNATAKA 563103 India |
| Phone |
7840820204 |
| Fax |
|
| Email |
AHOODA581@GMAIL.COM |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Hariprasad S |
| Designation |
Professor and Head of Unit, Department of Orthopedics, Sri Devaraj Urs Medical College |
| Affiliation |
Sri Devaraj Urs Academy of Higher Education and Research |
| Address |
Room no:6, Department of Orthopedics, RL Jalappa Hospital, Sri Devaraj Urs Academy of Higher Education and Research
Kolar KARNATAKA 563103 India |
| Phone |
9686071188 |
| Fax |
|
| Email |
DRHARIPRASAD.ORTHO@GMAIL.COM |
|
Details of Contact Person Public Query
|
| Name |
Dr Hariprasad S |
| Designation |
Professor and Head of Unit, Department of Orthopedics, Sri Devaraj Urs Medical College |
| Affiliation |
Sri Devaraj Urs Academy of Higher Education and Research |
| Address |
Room no:6, Department of Orthopedics, RL Jalappa Hospital, Sri Devaraj Urs Academy of Higher Education and Research
Kolar KARNATAKA 563103 India |
| Phone |
9686071188 |
| Fax |
|
| Email |
DRHARIPRASAD.ORTHO@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| RL Jalappa hospital and research centre, Tamaka, Kolar, Karnataka 563103 |
|
|
Primary Sponsor
|
| Name |
Dr Ankit |
| Address |
Room no 221, Men PG hostel, Sri Devaraj Urs Medical College, Kolar, Karnataka India 563103 |
| Type of Sponsor |
Other [self] |
|
|
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 Ankit |
RL Jalappa Hospital |
Room no:6, Department of Orthopedics, RL Jalappa Hospital, Sri Devaraj Urs Medical College, Kolar 563103
Karnataka India Kolar KARNATAKA |
7840820204
AHOODA581@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CENTRAL ETHICS COMITTEE OF SRI DEVARAJ URS ACADEMY OF HIGHER EDUCATION AND RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Plasma rich fibrin |
Platelet-rich fibrin (PRF) is an autologous cicatricial matrix. The biologic activity of the fibrin molecule is enough in itself to account for the significant cicatricial capacity of the PRF and the slow polymerization mode confers to the PRF membrane a particularly favorable physiologic architecture to support the healing process. A one time dose of 8ml plasma rich fibrin will be injected via intraarticular route knee joint. Patients will be evaluated after the procedure at 2nd, 4th, 8th, 12th, 24th weeks respectively. |
| Intervention |
Plasma rich platelets |
Concentrated platelets, derived from autologous blood, are concentrated into a polymer called platelet-rich plasma (PRP). PRP has chemotactic and mitogenic properties and functions as a growth factor agonist. The combination of large amounts of activated platelets, growth factors, and anti-inflammatory compounds alters the healing cascade and inflammatory pathway, reversing the degenerative process. A one time dose of 8ml plasma rich platelet will be injected via intraarticular route knee joint. Patients will be evaluated after the procedure at 2nd, 4th, 8th, 12th, 24th weeks respectively. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with early OA knee and Kellgren and Lawrence Scale (K&L) stage I and II.
Patient with persistent symptoms (pain, joint stiffness etc) irrespective of being treated with conservative treatment, including physical therapy, manipulation.
Patients were not under any other treatments for Osteoarthritis in the last month besides occasional analgesics.
|
|
| ExclusionCriteria |
| Details |
Patients with severe osteoarthritis ( K& L stage III and IV)
Patient treated with long release corticosteroids infiltration over the last month
Patient on immune suppresor or chemotherapy treatment
Local/ general infections; patient with previous joint replacement
Actue rheumatoid arthritis and rheumatoid immune diseases
Low platelets (100,000) or low fibrinogen |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the clinico-functional outcome of intraarticular platelet rich plasma and platelet rich fibrin in the management of early osteoarthritis of knee at 24th week |
24th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the clinico-functional outcome of intraarticular platelet rich plasma & platelet rich fibrin in the management of early osteoarthritis of knee at 2nd week, 4th week, 8th week, 12th week,24th week |
2nd week, 4th week, 8th week, 12th week, 24th week |
|
|
Target Sample Size
|
Total Sample Size="126" Sample Size from India="126"
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)
Modification(s)
|
01/05/2024 |
| 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="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response (Others) - Demographic data, results and conclusions of the study will be shared
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report Response - Analytic Code
- Who will be able to view these files?
Response (Others) - Researchers who have taken permission of the authors in this study
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [AHOODA581@GMAIL.COM].
- For how long will this data be available start date provided 01-03-2026 and end date provided 31-12-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NO
|
|
Brief Summary
|
|
SL.
|
PARTICUARS
|
COMMENTS
|
|
1.
|
Name of the PG student
|
DR. ANKIT
|
|
2.
|
Name of the Guide
|
DR. HARIPRASAD S.
|
|
3.
|
Title of the Topic
|
A COMPARATIVE STUDY OF CLINICO-FUNCTIONAL
OUTCOMES OF INTRAARTICULAR PLATELET RICH PLASMA AND PLATELET RICH FIBRIN IN
THE MANAGEMENT OF EARLY OSTEOARTHRITIS OF KNEE – PROSPECTIVE RANDOMIZED
CONTROL TRIAL
|
|
4.
|
Need for the study
|
PRP exerts its therapeutic mechanism via
growth factors stored in the α-granule of platelets. Platelet-rich plasma has
been proven to decrease inflammation, produce high-quality synovial fluid,
and reconstruction of degenerative cartilage but its efficacy is yet be
proven in conditions like osteoarthritis for long term results.
PRF showed promising
properties in connective tissue
regeneration and it is now widely
applied in chronic wound healing and
degenerative conditions. Patient treated with PRF showed better pain control
and more persistent pain relief in short and mid-term than those treated with
platelet rich plasma.
At present many
studies have been done to examine the effectiveness of PRP and PRF
individually, but a comparative study with a long term follow-up is yet to be
performed.
|
|
5.
|
Objectives of the study
|
· To assess the clinico-functional outcomes
of intra-articular injection of PRP in early OA knee
using
Visual Analogue Scale (VAS) and Western Ontario McMaster Universities
Osteoarthritis Index (WOMAC) at pre-procedure, post-procedure, 2nd,
4th, 8th, 12th, 24th weeks
respectively.
· To assess the clinico-functional outcomes intra-articular injection of PRF in early OA knee
using
VAS and WOMAC Osteoarthritis Index at pre-procedure, post-procedure, 2nd,
4th, 8th, 12th, 24th weeks
respectively.
· To compare clinico-functional outcomes intra-articular injection of PRP vs PRF in early OA
knee knee using VAS and WOMAC Osteoarthritis Index at
pre-procedure, post-procedure, 2nd, 4th, 8th,
12th, 24th weeks respectively.
|
|
7.
|
Material and Methods
|
STUDY
DESIGN:
A prospective comparative randomized control
trial.
To avoid patient selection bias patients
will be grouped into two groups.
Patients will be randomly selected as per the randomization list
generated by www.randomizer.org .
|
|
8.
|
Method of collection data including
sampling procedure
|
SOURCE OF DATA:
A comparative
prospective study will be conducted at R.L Jalappa hospital and research
center attached to Sri Devaraj Urs Medical college, affiliated to SDUAHER,
from MAY
2024 to OCTOBER 2024. 126 patients
with early Osteoarthritis of knee will be included in the study.
After full filling
the inclusion criteria and exclusion criteria, informed and written consent
will be obtained from all patients who agree to be a part of the study
Patients will be divided into 2 groups
•
Group A included 63
patients who were treated with intra-articular Platelet Rich Plasma injection
•
Group B included
63 patients who were treated with intra-articular Platelet rich fibrin
injection.
INCLUSION CRITERIA:
·
Patients of either gender, aged between 45
to 70 years
·
Patients with early OA knee and Kellgren and
Lawrence Scale (K&L) stage I and II
·
Patient with persistent symptoms (pain,
joint stiffness etc) irrespective of being treated with conservative
treatment, including physical therapy, manipulation
·
Patients were not
under any other treatments for Osteoarthritis in the last month besides
occasional analgesics
EXCLUSION CRITERIA:
· Patients with severe osteoarthritis (K&L
stage III and IV)
·
Patients treated
with long release corticosteroids infiltration over the last month
·
Patients on immune
suppressor or chemotherapy treatments
·
Acute rheumatoid
arthritis and rheumatoid immune diseases
·
Local/general
infections; patients with previous joint replacement
·
Low platelets
(<100.000) or low fibrinogen
|
|