CTRI Number |
CTRI/2019/04/018613 [Registered on: 15/04/2019] Trial Registered Prospectively |
Last Modified On: |
12/04/2019 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Biological |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Own blood product injection into joint and in bone in Osteoarthritis Knee |
Scientific Title of Study
|
Role of Intra-articular and Intra-osseous injections of Platelet Rich Plasma in OA Knee |
Trial Acronym |
IA and IO injections of PRP in OA Knee |
Secondary IDs if Any
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Apurba Barman |
Designation |
Associate Professor |
Affiliation |
AIIMS Bhubaneswar |
Address |
All India Institute of Medical Sciences, Bhubaneswar, Sijua, Patrapada
Khordha ORISSA 751019 India |
Phone |
9438884211 |
Fax |
|
Email |
apurvaa23@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Apurba Barman |
Designation |
Associate Professor |
Affiliation |
AIIMS Bhubaneswar |
Address |
All India Institute of Medical Sciences, Bhubaneswar, Sijua, Patrapada
ORISSA 751019 India |
Phone |
9438884211 |
Fax |
|
Email |
apurvaa23@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Apurba Barman |
Designation |
Associate Professor |
Affiliation |
AIIMS Bhubaneswar |
Address |
All India Institute of Medical Sciences, Bhubaneswar, Sijua, Patrapada
ORISSA 751019 India |
Phone |
9438884211 |
Fax |
|
Email |
apurvaa23@gmail.com |
|
Source of Monetary or Material Support
|
All India Institute of Medical Sciences, Bhubaneswar |
|
Primary Sponsor
|
Name |
All India Institute of Medical Sciences Bhubaneswar |
Address |
AIIMS, Bhubaneswar
Sijua, Patrapada, PO Dumuduma
Dist: Khurda, Orissa
Pin 751019 |
Type of Sponsor |
Government funding agency |
|
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 Apurba Barman |
PMR OPD |
Room no 6 Physical Medicine & Rehabilitation OPD Department of Physical Medicine & Rehabilitation
AIIMS Bhubaneswar Khurda 751019 Khordha ORISSA |
09438884211
apurvaa23@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
IEC AIIMS Bhubaneswar |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Intra-articular and intra-osseous PRP Group (IA,IO-PRP) |
Under aseptic conditions, One PRP (8ml) intraarticular injection and two PRP intraosseous injections (5ml each ) will be given under general anesthesia and standard monitoring. Patient will be induced with midazolam (0.05 mg/kg) and fentanyl (2 mcg/kg) intravenous along with propofol (2mg/kg). Thereafter, anesthesia will be maintained by mask ventilation with oxygen in nitrous oxide and propofol (1mg/kg) boluses as and when required depending on the duration of the procedure |
Comparator Agent |
Intra-articular PRP Group (IA-PRP) |
The patient will be positioned in a supine position with knee in full extension. Under aseptic conditions, after evacuating of synovial fluid, 8mL of PRP will be injected into supra-patellar pouch through supra-lateral approach with an 18-gauge needle without local anesthetic. The knees will be immobilized for 10 minutes. The patients will be discharged after 30 minutes of observation.
|
|
Inclusion Criteria
|
Age From |
40.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1. Patients aged 40-65 years, who are able to walk with a painful knee and fulfilled the criteria for knee OA of the medial femorotibial joint, as defined by the American College of Rheumatology (ACR).
2. Persisting Knee Pain due to OA Knee (Grade II/III, according to the radiological classification of knee OA defined by Kellgren and Lawrence)
3. Pain of at least 20 mm on a 0-100mm VAS when asked: “how painful is your knee during level walking?â€
4. If both knees involved, participants choose one or both knees to be treated.
5. Willing to participate in all assessment
|
|
ExclusionCriteria |
Details |
1) Severe OA Knee (Grade IV, according to Kellgren and Lawrence classification)
2) Haemoglobin level < 10gm%
3) Inflammatory or post-infectious knee arthritis
4) History of prior knee replacement repair
5) Prior fracture of the knee joint
6) Any Knee injection within 3 months
7) Daily use of opioid medication
8) Coexisting Backache, other chronic pain disorder
9) Body mass index (BMI) greater than 40 kg/m2
10) Blood disorders, hematological, cardiac, hepatic or renal disorders.
11) Patients who had received either an oral, topical or intra-articular steroid during the four weeks before the study pregnancy
12) Co-morbidity severe enough to prevent participation in the study protocol including at-home exercise or attendance at scheduled injection appointments.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Visual analogue pain Score (0-10cm)
|
0 month (V1), 1.5 months (V2), 3 months (V3) |
|
Secondary Outcome
|
Outcome |
TimePoints |
KOOS questionnaire (0-100)
Range of motion of affected knee joint |
0 month, 1.5 months, 3 months |
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
15/05/2019 |
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
|
Not applicable |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Osteoarthritis (OA) Knee is a common debilitating condition, for which there is no cure. Although OA is not a life-threatening condition, the severity of this disease lies in the continuous pain and functional impairment.
It is evident from the literature, that cartilage loss is not only a pathologic process that triggers OA. Subchondral bone is identified as the starting place for pathologic changes, and cartilage is the victim of this process. In OA, the sub-chondral bone undergoes changes which include microcrack, structural defects and progressive replacement of the subchondral marrow with fibro neurovascular mesenchymal tissue. Hence, lesions in this subchondral tissue lead inevitably to the onset of OA, if they are not treated properly.
The popular biologic therapy, autologous platelet rich plasma (PRP), prepared from patients own blood, contains a pool of growth factors for cartilage repair. Biological analysis of PRP has also demonstrated an anti-inflammatory effect on the intra-articular environment. The use of platelet-rich plasma (PRP) for the treatment of osteoarthritis (OA) has demonstrated mixed clinical outcomes in randomized controlled trials.
As it is yet to establish which of the joint tissues, among synovial membranes, synovial fluid, articular cartilage or sub-chondral bones, is the primary driver of OA Knee, it is not clear whether we should target one or multiple tissues or structures during interventions. We can assume that targeting several joint tissues or structures at a time, can provide a better result.
Hence, we are planning to conduct this study to see whether the addition of intra-osseous injections of PRP directly into the subchondral bone to conventional intra-articular treatment would achieve a better positive effect in OA Knee. |