| CTRI Number |
CTRI/2024/05/068055 [Registered on: 29/05/2024] Trial Registered Prospectively |
| Last Modified On: |
27/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Injection of blood cell components in knee joint for joint pain patients |
|
Scientific Title of Study
|
Efficacy of intraarticular injection Of autologous platelet rich plasma in patients with 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 |
Vignesh Rajan |
| Designation |
Junior Resident in Department of Anaesthesiology |
| Affiliation |
Gandhi medical college, bhopal |
| Address |
Operation Theatre ,2nd Floor , Department Of Anaesthesia Gandhi Medical College,hamidia Hospital
Bhopal MADHYA PRADESH 462001 India |
| Phone |
9659395301 |
| Fax |
|
| Email |
drvigrajan1163@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Urmila keshari |
| Designation |
Professor in department of anaesthesia |
| Affiliation |
Gandhi medical college ,bhopal |
| Address |
Operation Theatre ,2nd Floor , Department Of Anaesthesia Gandhi Medical College,hamidia Hospital
Bhopal MADHYA PRADESH 462001 India |
| Phone |
9862757745 |
| Fax |
|
| Email |
drsurmi@rediffmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Jaideep singh |
| Designation |
Associate Professor in department of anaesthesia |
| Affiliation |
Gandhi medical college ,bhopal |
| Address |
Operation Theatre ,2nd Floor , Department Of Anaesthesia Gandhi Medical College,hamidia Hospital
Bhopal MADHYA PRADESH 462001 India |
| Phone |
9827767022 |
| Fax |
|
| Email |
singhdrjaideep@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gandhi medical college, hamidia hospital,
Bhopal
Madhya pradesh 462001 |
|
|
Primary Sponsor
|
| Name |
Gandhi medical college |
| Address |
Gandhi medical college
Hamidia Hospital
Bhopal
Madhya pradesh 462001 |
| 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 Vignesh rajan |
Gandhi medical college |
Room no 2,operation theatre,2nd floorGandhi Medical College,hamidia Hospital Bhopal MADHYA PRADESH |
9659395301
drvigrajan1163@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee,Gandhi medical college bhopal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injecting the platelet rich plasma in knee joint |
15-20 ml of blood withdrawn and prp is made and injected in to knee joint as regenerative therapy.this will be done once In a week for 3 consecutive weeks and pain scoring will be assessed at end of 3 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient with knee joint swelling/pain for more than 3 months
Xray showing degenerative changes |
|
| ExclusionCriteria |
| Details |
Patient refusal or not giving consent
Infected knee joint /(Osteomyelitis)
Hb<10gm/dl
Platelet < 1.5 lakh cells/mm3 Pregnantwomen/breast feeding women
Any Hematological disorders like CLL, ALL, AML Rheumatological disorders like RA, SLE Osteoarthritis grade I & IV |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the therapeutic effectiveness of PRP as a intraarticular injection to knee joint for OA patients by Womac scoring |
In 3 sitting of injection in gap of 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Occurrence of side effects and complications |
In 3 sitting of injection in gap of 1 week |
|
|
Target Sample Size
|
Total Sample Size="86" Sample Size from India="86"
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 2 |
|
Date of First Enrollment (India)
|
10/06/2024 |
| 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)
|
Not Applicable |
| 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
|
Osteoarthritis is a degenerative disease involving joint damage, an inadequate healing response and progressive deterioration of the joint architecture the commonly affects the knee joints. The most common conservative management for osteoarthritis is NSAIDS drugs, chondroitin sulfate, glucocorticoid. However these methods have various adverse effect & healing ability of cartilage tissue is not up to the mark.so it can give only short time resolution. • Autologous blood derived products possess much promise in the repair and regeneration of tissue and have important role in inflammation, angiogenesis, cell migration and metabolism in pathological conditions including osteoarthritis • PRP is an autologous mixture of highly concentrated platelets and associated growth factors and other bioactive components produced by centrifugal separation of whole blood that is mostly used in orthopaedic and sports medicine practice to treat bone, tendon and ligament injuries. • PRP may induce a regenerative response by improving the metabolic function of damaged structures • PRP also contains high concentration of growth factors,VEGF,PDGF,TGFbeta • The supra-physiological release of platelet derived growth factors directly at the site of cartilage disease, may stimulate the natural regenerative signalling cascade and enhance the healing of tissue with further mediation of the anti-inflammatory response The Ultimate aim of the study to assess the therapeutic effectiveness of platelet rich plasma as intraarticular knee joint injection for a patients with osteoarthritis by using WOMAC scoring
This study includes the sample size of between 4070 86 patients belong the age group year and history of knee pain more than 3 months hi story of patient was taken in pain clinic and they underwent . Detailed a thorough physical examination. Patient s fulfilling the criteria were explained about treatment modality in detail and informed consent was obtained & their pain sc ore by WOMAC scoring was assessed P latelet Rich Plasma(PRP) PREPARATION : About 30 ml of patients blood was taken from vials 4.2ml of acid dextrose solution in sterile 5 ml of PRP. antecubital vein and mixed with to get about 3 and it centrifuged telet After centrifuging the concentration of pla patients blood was assessed. Procedure: in PRP and After all those initial preparation, the patient was taken to operating with proper monitoring with pulse oximeter, ECG, non invasive blood pressure through room out the procedure. Two large IV cannula was established and one unit of RL was started in one IV cannula and inj. Ondansetron 4mg IV , inj. Midazolam 1mg IV , inj. Fentanyl 25 mcg was given as antiemetic, anxiolytic, analgesic basis respectively. Patient was lies on his back , exposing slightly flexed the knee joint and the affected knee joint . Routine disinfection was done with iodophor . inj. lignocaine p 2% was infiltrated in to the skin / subcutaneous tissue. And then 3 ml of autologous PRP was administered in the patellofemoral joint space at outer edge of patella and then knee joint was slightly flexed and extended for several times to ma ke sure PRP fully cover the articular surface. After the injection patient was instructed to avoid strenuous same exercise And the procedure was done once in a week for a 3 consecutive week After the 3 shot of PRP injection in 3 consecutive week, the patients WOMAC score was assessed and it was compared with their initial WOMAC scoring. |