| CTRI Number |
CTRI/2025/07/092111 [Registered on: 31/07/2025] Trial Registered Prospectively |
| Last Modified On: |
31/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective study |
| Study Design |
Other |
|
Public Title of Study
|
A Study on How a Treatment Made from the Person’s Own Blood Helped People with Knee Pain Feel Better |
|
Scientific Title of Study
|
Platelet-Rich Plasma in Osteoarthritis of Knee: A Retrospective Study on Functional Improvement and Quality of Life |
| 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 Arvind Kumar Sharma |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Raebareli |
| Address |
Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj,Madhupuri, Uttar Pradesh 229405
Rae Bareli UTTAR PRADESH 229405 India |
| Phone |
6388930133 |
| Fax |
|
| Email |
arvindkgmu25@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Arvind Kumar Sharma |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Raebareli |
| Address |
Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj,Madhupuri, Uttar Pradesh 229405
UTTAR PRADESH 229405 India |
| Phone |
6388930133 |
| Fax |
|
| Email |
arvindkgmu25@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Arvind Kumar Sharma |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Raebareli |
| Address |
Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj,Madhupuri, Uttar Pradesh 229405
UTTAR PRADESH 229405 India |
| Phone |
6388930133 |
| Fax |
|
| Email |
arvindkgmu25@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Madhupuri, Uttar Pradesh 229405, India |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Raebareli, Uttar Pradesh |
| Address |
All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Madhupuri, Uttar Pradesh 229405 |
| Type of Sponsor |
Government medical college |
|
|
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 Arvind Kumar Sharma |
All India Institute of Medical Sciences, Raebareli, Uttar Pradesh |
Room 22/28, Ground floor, Department of
Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Raebareli, Dalmau Rd,Munshiganj,Madhupuri, Uttar Pradesh 229405 Rae Bareli UTTAR PRADESH |
6388930133
arvindkgmu25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC), AIIMS Raebareli, Uttar Pradesh, India |
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 |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Osteoarthritis of knee upto Grade 3 according to Kellgren Lawrence radiological grading
Patients who have received PRP intra articular injections
Age more than 18 years
|
|
| ExclusionCriteria |
| Details |
Patients who were not compliant, lost to follow-up
Patient with multiple comorbidities like uncontrolled Diabetes Mellitus, Coronary Artery Disease, Chronic Kidney disease.
Patients with inflammatory diseases, such as Axial spondyloarthropathy, Rheumatoid arthritis etc.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numeric Pain Rating Scale (NPRS)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Knee injury and Osteoarthritis Outcome Score (KOOS)
|
at baseline, 1month, 3months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SF-12 Health Survey for quality of life |
at baseline, 1month, 3months 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)
|
11/08/2025 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 - NO
|
|
Brief Summary
|
Title: Platelet-Rich Plasma in Osteoarthritis of Knee: A
Retrospective Study on Functional Improvement and Quality of Life
Aim: To study the outcome of using Platelet-rich plasma in pain
relief for patients with Osteoarthritis of knee joints
Primary objectives:
To quantitatively evaluate the reduction in knee joint pain
following intra-articular administration of Platelet-Rich Plasma (PRP) in
patients diagnosed with knee osteoarthritis.
To assess the extent of
functional improvement post-PRP intervention in individuals with knee
osteoarthritis, in terms of gait ability, joint range of motion, and
performance in activities of daily living.
To compare clinical
outcomes between patients with Grade 2 and Grade 3 (based on Kellgren-Lawrence
classification) osteoarthritis of the knee, based on the, with respect to pain
reduction and functional enhancement following PRP therapy.
Secondary objectives:
To assess improvement of quality of life (QOL)
after PRP.
To identify factors influencing treatment
response, such as age, BMI, baseline severity of symptoms, or comorbidities.
To evaluate the effect of home environment and living situation on
outcomes in patients with OA knee.
To analyze the duration of symptomatic relief
and functional gains post-PRP injection over the follow-up period.
Osteoarthritis
(OA) is a common progressive degenerative condition affecting weightbearing
joints, commonly the knee joints. Platelet-rich plasma (PRP) refers to a
portion of plasma that contains a platelet concentration significantly higher
than that found in normal peripheral blood. It is prepared by centrifuging a
sample of the patient’s blood at high speed, which separates the red blood
cells from the plasma. Various growth factors and cytokines are released after
the degranulation of platelets and to accelerate cartilage matrix synthesis,
restrain synovial membrane inflammation, and promote cartilage healing. Owing
to the properties of regenerative effect and anti-inflammatory potential, PRP
is widely used in musculoskeletal diseases, such as OA knee.
Materials and
Methods
Study Type: Retrospective
study
Study duration: 6
months
Study Design: This
study will be conducted in the Department of Physical Medicine and
Rehabilitation (PMR) at the All India Institute of Medical Sciences (AIIMS),
Raebareli, Uttar Pradesh, India.
Eligibility
criteria:
Inclusion
Criteria:
Patients with Osteoarthritis of knee upto Grade 3 according to
Kellgren Lawrence radiological grading
Patients who have received PRP intra articular injections
Age more than 18 years
Exclusion
Criteria:
Patients who were not compliant, lost to follow-up
Patient with multiple comorbidities like uncontrolled Diabetes
Mellitus, Coronary Artery Disease, Chronic Kidney disease.
Patients with inflammatory diseases, such as Axial
spondyloarthropathy, Rheumatoid arthritis etc.
Procedure: Patients
who had visited the out-patient and in-patient Dept of PMR during the time
period of May 2022 till May 2025 have been included in the study.
Demographic details and evaluation of history, complete physical
examination, values of functional scales (NPRS, WOMAC, KOOS scales) will be
noted in a working case proforma.
The subjects’ response of change of severity of pain will be
assessed using Numerical Pain Rating Scale (NPRS). Assessment of function and
ability to carry out ADL will be assessed using Western Ontario and McMaster
Universities Osteoarthritis Index (WOMAC) and Knee
injury and Osteoarthritis Outcome Score (KOOS).
Data collection: Data collection of
outcome variables will be done at baseline, 1month, 3months and 6 months on OPD
visits, following the first admission in IPD.
|