| CTRI Number |
CTRI/2025/06/089113 [Registered on: 19/06/2025] Trial Registered Prospectively |
| Last Modified On: |
18/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Platelet-Rich Plasma (platelet concentration) Injections on cartilage growth Marker (Cartilage Oligomeric Matrix Protein) Levels in Knee Osteoarthritis: A Randomized Controlled Trial |
|
Scientific Title of Study
|
Effect of Intra-Articular Platelet-Rich Plasma (PRP) Injections on Cartilage Oligomeric Matrix Protein (COMP) Levels in Knee Osteoarthritis: A Randomized Controlled 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 Diganta Borah |
| Designation |
Professor |
| Affiliation |
AIIMS Guwahati |
| Address |
Head Of Department, PMR, AIIMS Guwahati
Kamrup
ASSAM
781101
India |
| Phone |
917503005456 |
| Fax |
|
| Email |
digantaborah@aiimsguwahati.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Diganta Borah |
| Designation |
Professor |
| Affiliation |
AIIMS Guwahati |
| Address |
Head Of Department, PMR, AIIMS Guwahati
Kamrup
ASSAM
781101
India |
| Phone |
917503005456 |
| Fax |
|
| Email |
digantaborah@aiimsguwahati.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Diganta Borah |
| Designation |
Professor |
| Affiliation |
AIIMS Guwahati |
| Address |
Head Of Department, PMR, AIIMS Guwahati
Kamrup
ASSAM
781101
India |
| Phone |
7891011974 |
| Fax |
|
| Email |
digantaborah@aiimsguwahati.ac.in |
|
|
Source of Monetary or Material Support
|
| Department of PMR and Department of Transfusion Medicine and Blood bank, AIIMS Guwahati |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 Saurabh Gusaiwal |
Procedure room(1082), Department of PMR |
Department of PMR, AIIMS Guwahati, Changsari, Kamrup, Assam
Kamrup
ASSAM |
7891011974
gusaiwalsaurabh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,AIIMS Guwahati |
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 |
Platelet Rich Plasma injection |
Intra-articular PRP injections
Three doses of PRP with each dose 3 ml, will be administered in the intra-articular knee one week apart. |
| Comparator Agent |
standard conservative treatment |
patient education, lifestyle modifications, therapeutic exercises, topical analgesics, oral analgesics and further treatment as per ACR guidelines |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with primary OA knee fulfilling ACR criteria (1986)
Patients with OA knee symptoms of more than 3 months’ duration
|
|
| ExclusionCriteria |
| Details |
Patients with secondary knee osteoarthritis
Uncontrolled Hypertension and Diabetes Mellitus Type 2
Inflammatory arthritis, spondyloarthropathies.
History of trauma with diagnosed ligament tear
History of surgery, manipulation, mobilization, or arthroscopy
History of steroid, local anaesthetic, or hyaluronic acid injection over the last 3 months
Bleeding disorders, patients using anticoagulant or antiaggregant medications
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study will show improvement, if any, in serum COMP levels in OA knee patients receiving PRP injection at 6 weeks follow-up. |
baseline 0 weeks, 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The study may also establish a correlation between change in COMP levels & the functional & pain status of the patients after PRP injections. |
baseline 0 weeks & 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
01/07/2025 |
| 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="0"
Days="0" |
|
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
|
This study is a randomized controlled trial to be conducted in the Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences (AIIMS) Guwahati in patients diagnosed with primary knee osteoarthritis according to ACR criteria. After securing ethical clearance, consent will be obtained from each patient before enrolment into the study. Biochemical evaluation involves serum COMP level, and clinical evaluation involves parameters such as VAS for pain intensity and KOOS for OA functional assessment. A total of 110 participants meeting the inclusion and exclusion criteria will be enrolled and randomly allocated into two groups: 55 patients in the intervention group and 55 patients in the control group. The intervention group will receive 3 doses of PRP injections, which will be administered one week apart along with standard conservative treatment. The control group will receive standard conservative treatment. Follow-up assessment will be done 6 weeks after the last dose of PRP. Documentation will be done, and data will be collected and analysed using SPSS version 29. |