FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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?”

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.

 
Close