| CTRI Number |
CTRI/2025/01/078953 [Registered on: 17/01/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
Type of Study
Modification(s)
|
Prospective Observational |
| Study Design |
Other |
|
Public Title of Study
|
Study to Assess the Safety and Effectiveness of Injection Hyaluronic acid and Injection Hyaluronic acid with platelet rich plasma in patients with Knee Osteoarthritis |
Scientific Title of Study
Modification(s)
|
Single Centre, Prospective, observational Study to Assess and Compare the Safety and Efficacy of Injection Biolevox HA ONE (Hyaluronic acid) and Injection Monoshot (Hyaluronic acid combined with platelet-rich plasma) in patients with Knee Osteoarthritis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lokesh A Veerappa |
| Designation |
Consultant Orthopaedic and Robotic Joint Replacement Surgery |
| Affiliation |
Manipal Hospital |
| Address |
Room No 35
Number 98 Upper Basement Manipal Hospitals HAL Old Airport Rd
Kodihalli
Bengaluru
India
Bangalore
KARNATAKA
560017
India |
| Phone |
9845740443 |
| Fax |
|
| Email |
drlokeshav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lokesh A Veerappa |
| Designation |
Consultant Orthopaedic and Robotic Joint Replacement Surgery |
| Affiliation |
Manipal Hospital |
| Address |
Room No 35
Number 98 Upper Basement Manipal Hospitals HAL Old Airport Rd
Kodihalli
Bengaluru
India
Bangalore
KARNATAKA
560017
India |
| Phone |
9845740443 |
| Fax |
|
| Email |
drlokeshav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lokesh A Veerappa |
| Designation |
Consultant Orthopaedic and Robotic Joint Replacement Surgery |
| Affiliation |
Manipal Hospital |
| Address |
Room No 35
Number 98 Upper Basement Manipal Hospitals HAL Old Airport Rd
Kodihalli
Bengaluru
India
Bangalore
KARNATAKA
560017
India |
| Phone |
9845740443 |
| Fax |
|
| Email |
drlokeshav@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Lokesh A Veerappa,
Manipal Hospital
HAL Old Airport Rd
Kodihalli
Bengaluru
Karnataka 560017
India
|
|
|
Primary Sponsor
|
| Name |
Dr Lokesh A Veerappa |
| Address |
Room No 35
Number 98 Upper Basement Manipal Hospitals HAL Old Airport Rd
Kodihalli
Bengaluru-560017
India |
| Type of Sponsor |
Other [self] |
|
|
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 Lokesh A Veerappa |
Manipal Hospital |
Room No. 35
No 98 Upper Basement Manipal Hospitals
HAL Old Airport Rd
Kodihalli
Bengaluru
Karnataka 560017
India
Bangalore
KARNATAKA |
9845740443
drlokeshav@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee of Manipal Hospitals, Banglore |
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 |
Injection Biolevox™ HA ONE |
Injection Biolevox™ HA ONE with pH 6.8-7.4 contains high molecular weight sodium hyaluronate produced by bacterial fermentation, non-animal origin. lt is sterile and non- pyrogenic. The product is for intra-articular use to improve viscosity of synovial fluid. It is indicated for pain and decreased articular mobility associated with traumatic or degenerative changes including osteoarthritis. The pre-filled syringe with 4.8 ml of gel is dedicated mostly for knee joints. |
| Comparator Agent |
Injection Monoshot (hyaluronic acid combined with platelet-rich plasma) |
Injection Monoshot (hyaluronic acid combined with platelet-rich plasma) is a procedure pack designed for isolation and separation of platelet-rich plasma (PRP) from the patient’s blood, and then its simultaneous intra-articular injection with sodium hyaluronate.
Monoshot HA with pH 6.8-7.4 contains high molecular weight sodium hyaluronate produced by bacterial fermentation, non-animal origin. It is sterilized and non-pyrogenic. Monoshot HA is intended for intra-articular injection to increase the viscosity of the synovial fluid. It is indicated for pain and decreased articular mobility associated with traumatic or degenerative changes including osteoarthritis, where there is a need to improve the regenerative properties at the specific areas.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female participants from 18 to 70 years of age at the time of consent.
2. Patient diagnosed with Knee OA as determined by the investigator using ACR Clinical Classification Criteria for Osteoarthritis of the knee fulfilling the following criteria – Pain in the knee and 3 of the following:
i. age more than 50 years of age
ii. Less than 30 minutes of morning stiffness
iii. Crepitus on active motion
iv. Bony enlargement
v. No palpable warmth of synovium
3. Participants/ Legally Acceptable Representative who are willing to provide written Informed Consent and comply with study procedures.
|
|
| ExclusionCriteria |
| Details |
1. Participants with BMI greater than or equal to 35 kg/m2
2. Participants who had undergone previous surgery in the same or contralateral knee
3. Participants with a history of deep vein thrombosis (DVT)
4. Patients with generalized OA
5. Pregnant and lactating female at the time of screening
6. Corticosteroid injection at treatment site within 1 month
7. Systemic use of corticosteroids within 2 weeks
8. Has received hyaluronic acid, PRP injection within 6 months
9. Participants with any condition which makes the subject unsuitable for study participation which as per the investigator would jeopardize the outcome of the trial or participant who, in the judgment of the investigator, will be unlikely to comply with the requirements of this clinical investigation plan.
|
|
Method of Generating Random Sequence
Modification(s)
|
Not Applicable |
Method of Concealment
Modification(s)
|
Not Applicable |
Blinding/Masking
Modification(s)
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess functional outcomes of Knee in both the cohorts |
Screening/Baseline, 1 month, 3 months, 6 months and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate knee pain in each cohort
2. To assess quality of life in each cohort
3. To assess the safety in each cohort
4. To evaluate the requirement of an additional dose of investigational product/s or other therapy modalities
|
1. Screening/Baseline, 1 month, 3months, 6 months and 12 months.
2. Screening/ Baseline, 12 months
3. Screening/Baseline, 1 month, 3 months, 6 months and 12 months
4. 1 month, 3 months, 6 months and 12 months
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
08/09/2025 |
| 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
Modification(s)
|
This is a Single Centre, Prospective, observational Study to Assess and Compare the Safety and Efficacy of Injection Hyaluronic acid and Injection Hyaluronic acid combined with platelet-rich plasma in patients with mild to moderate Knee Osteoarthritis |