| CTRI Number |
CTRI/2020/02/023376 [Registered on: 17/02/2020] Trial Registered Prospectively |
| Last Modified On: |
16/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the efficacy of injecting platelet rich plasma in osteoarthritis knee and its relation with MAT2B gene |
|
Scientific Title of Study
|
Efficacy Of Intra-Articular Injection Of Platelet Rich Plasma And The Modulation Of mRNA Expression Of MAT2B Gene In Patients With Early Stage Osteoarthritis Knee:A Prospective Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Parul Gupta |
| Designation |
Post Graduate student |
| Affiliation |
University College Of Medical Sciences and GTB Hospital |
| Address |
Department Of Anaesthesiology And Critical Care, 2nd Floor, GTB Hospital, University College Of Medical Sciences, Dilshad Garden, New Delhi
East
DELHI
110095
India |
| Phone |
9899779552 |
| Fax |
|
| Email |
parul149@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Kumar |
| Designation |
Professor and Head Of Department |
| Affiliation |
University College Of Medical Sciences and GTB Hospital |
| Address |
Department Of Anaesthesiology And Critical Care, 2nd Floor, GTB Hospital, University College Of Medical Sciences, Dilshad Garden, New Delhi
New Delhi
DELHI
110095
India |
| Phone |
9810431367 |
| Fax |
|
| Email |
profashoksaxena2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Parul Gupta |
| Designation |
Post Graduate student |
| Affiliation |
University College Of Medical Sciences and GTB Hospital |
| Address |
Department Of Anaesthesiology And Critical Care, 2nd Floor, GTB Hospital, University College Of Medical Sciences, Dilshad Garden, New Delhi
DELHI
110095
India |
| Phone |
9899779552 |
| Fax |
|
| Email |
parul149@gmail.com |
|
|
Source of Monetary or Material Support
|
| Umiversity College Of Medical Sciences And GTB Hospital Dilshad Garden Delhi |
|
|
Primary Sponsor
|
| Name |
University College Of Medical Sciences |
| Address |
University College Of Medical Sciences And GTB Hospital, Dilshad Garden, New Delhi |
| 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 Parul Gupta |
University College of Medical Sciences and GTB Hospital |
Deptt. of Anaesthesiology, Critical Care and Pain Medicine, second floor, GTB Hospital and UCMS, Delhi
East
DELHI |
9899779552
parul149@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Injection Of Platelet Rich Plasma In Patients Of Primary Osteoarthritis Knee In One With More Severe Clinico-radiological Disease |
Injection Of Platelet Rich Plasma Containing 3-4 ml of PRP Given Intra-articular Once In Patients Of Primary Osteoarthritis Knee In One With More Severe Clinico-radiological Disease and Pain Scores Followed Up to 3 months |
| Intervention |
Injection Of Platelet Rich Plasma In Patients Of Primary Osteoarthritis Knee In One With More Severe Clinico-radiological Disease |
Injection Of Platelet Rich Plasma containing 3-4 ml Of PRP In Patients Of Primary Osteoarthritis Knee In One With More Severe Clinico-radiological Disease Given Intra-articular Once And Pain Scores Followed Up for 3 Months |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)Age >45 years and <65 years
2)Diagnosed case of osteoarthritis knee based on clinico- radiological diagnosis
3)In case of bilateral symptoms side with more significant symptom receives treatment
4)NRS score of ≥4/10 over minimum 3 months
5)Grade 1, 2, 3 of Kellgren and Lawrence system of classification of severity of knee
OA(28)
6)Patients who have tried atleast 3 months of non-invasive conservative treatment
including lifestyle modification before the beginning of therapy |
|
| ExclusionCriteria |
| Details |
1)Diagnosis of secondary OA (Post-traumatic, post-surgical and post-inflammatory
osteoarthritis)
2)Recent intra-articular injection of corticosteroids within last 3 months and prior treatment
with hyaluronic acid in past 6 months
3)Anemia (Hb < 10gm%) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain score,
stiffness score, physical function score and WOMAC total score at various designated
intervals
2)NRS pain score at various designated intervals |
baseline and at the end of 1st week, 2nd week, 4th week, 8th week and 12th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Lequesne scores following implementation of injection at various designated intervals
2)Neuropathic component of pain using NPSI scores at various designated intervals
3)The quality of life QoL usng SF-12 questionnaire scores at various designated
intervals
4)Modulation in mRNA expression of MAT2B genes at baseline and after 12 weeks
following intra-articular treatment. |
baseline and at the end of 1st week, 2nd week, 4th week,6th week,8th week and 12th week.
|
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 4 |
|
Date of First Enrollment (India)
|
17/02/2020 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The present prospective interventional study aims to evaluate the efficacy of intra-articular injection of platelet rich plasma and the
modulation of mRNA expression of MAT2B gene in patients with early stage osteoarthritis
knee. Patients of age >45 years and <65 years who are diagnosed case of osteoarthritis knee based on clinico- radiological diagnosis will be included. In case of bilateral symptoms side with more significant symptom receives treatment with NRS score of ≥4/10 over minimum 3 months and Grade 1, 2, 3 of Kellgren and Lawrence system of classification of severity of knee
OA, who have tried atleast 3 months of non-invasive conservative treatment
including lifestyle modification before the beginning of therapy. Patients will be excluded if a diagnosis of secondary OA (Post-traumatic, post-surgical and post-inflammatory
osteoarthritis) or history of recent intra-articular injection of corticosteroids within last 3 months or prior treatment
with hyaluronic acid in past 6 months or Anemia (Hb < 10gm%). Procedure of intra-articular injection of PRP will be conducted under C-arm
fluoroscopic guidance under full aseptic precautions in the operation theatre. Primary outcome measures are Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain score, stiffness
score, physical function score and total score at various designated intervals Secondary Outcome measures are NRS pain scores, Lequesne scores, NPSI scores, SF-12 questionnaire. Comparison of modulation in mRNA expression of MAT2B genes at baseline and at the end of 12th week following intra-articular treatment. |