| CTRI Number |
CTRI/2025/05/086494 [Registered on: 07/05/2025] Trial Registered Prospectively |
| Last Modified On: |
05/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the Safety and Performance of Intra-Articular Hyaluronic Acid (HA)(BIOVISC ORTHO) in Patients with wrist/elbow/shoulder/Hip joint disorder(s) |
|
Scientific Title of Study
|
An open-label, multicenter, prospective study to evaluate the safety and performance of intra-articular hyaluronic acid (BIOVISC ORTHO) in the management of wrist, elbow, shoulder and hip joint disorders |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aniket Gupta |
| Designation |
Consultant Orthopedic Surgeon |
| Affiliation |
Pushpam Superspeciality Hospital |
| Address |
Pushpam Superspeciality Hospital, Upvan Residency, near Dharti Bungalows IOC, road, Chandkheda, Tragad, Ahmedabad, Gujarat
Ahmadabad
GUJARAT
382424
India |
| Phone |
9825677971 |
| Fax |
|
| Email |
guptaaniket30794@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bhargav Joshi |
| Designation |
Assistant General Manager |
| Affiliation |
BIO-TECH VISION CARE PVT. LTD |
| Address |
Block 1, Abhishree Corporate Park, Opp. Swagat Bunglow, BRTS Stop
Bopal - Ambli Road, Ahmedabad
Ahmadabad
GUJARAT
380058
India |
| Phone |
9925925667 |
| Fax |
|
| Email |
bhargav.joshi@biotechhealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhargav Joshi |
| Designation |
Assistant General Manager |
| Affiliation |
BIO-TECH VISION CARE PVT. LTD |
| Address |
Block 1, Abhishree Corporate Park, Opp. Swagat Bunglow, BRTS Stop
Bopal - Ambli Road, Ahmedabad
Ahmadabad
GUJARAT
380058
India |
| Phone |
9925925667 |
| Fax |
|
| Email |
bhargav.joshi@biotechhealthcare.com |
|
|
Source of Monetary or Material Support
|
| BIOTECH VISION CARE PVT. LTD.
Block 1, Abhishree Corporate Park, Opp. Swagat Bunglow, BRTS Stop
Bopal - Ambli Road, Ahmedabad - 380 058 Gujarat India |
|
|
Primary Sponsor
|
| Name |
BIOTECH VISION CARE PVT. LTD |
| Address |
Block 1, Abhishree Corporate Park, Opp. Swagat Bunglow, BRTS Stop
Bopal - Ambli Road, Ahmedabad - 380 058 Gujarat India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shrey Desai |
Matis Multi Speciality Hospital |
Department of orthopedics, Matis Multi-speciality hospital opp. Adani CNG Gas Station, Near Motera cross road, Ahmedabad, Gujarat
Ahmadabad
GUJARAT |
9722280170
shreydesai1995@gmail.com |
| Dr Aniket Gupta |
Pushpam Superspeciality Hospital |
First floor , Block-B, 108-112, Department of orthopedics, Upvan Residency, near Dharti Bungalows IOC, Road, Chandkheda, Tragad, Ahmedabad, Gujarat 382424
Ahmadabad
GUJARAT |
9825677971
guptaaniket30794@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Shakti Hospital Ethics Committee |
Approved |
| Shakti Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M255||Pain in joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intra-articular hyaluronic acid |
A single dose, 90mg/3ml will be administered to the wrist, elbow, shoulder, or hip, as appropriate for the participant’s diagnosed joint condition. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Mild to moderate documented diagnosis of osteoarthritis that fulfill the ACR (American College of Rheumatology) criteria.
Patients with consistent symptoms (joint pain, crepitus, swelling, effusion alone or combination of these symptoms).
Patients who are willing to discontinue all non-steroidal anti-inflammatory drugs (NSAIDs) or other analgesic medication taken for any condition, including their pain. However, patients will be allowed to use only acetaminophen or aspirin as a rescue pain medication during the study period. The patients must abstain from medication use 24 hours prior to any study visit.
greater then or equal to 50/100 VAS pain as a result of wrist, elbow, shoulder and hip joint disorders.
More then or equals to 3 months of pain after onset of symptoms that has failed conservative treatments (e.g., medications, physical therapy)
|
|
| ExclusionCriteria |
| Details |
Pregnant or lactating women and women of childbearing potential not willing to use adequate contraception.
Patients unable to stay in the study for 6 months, non- cooperating, not able to understand.
Patients having previously undergone surgery on target joint, including arthroscopy.
Patients with neurological deficit, with primary inflammatory joint disease, intra-articular tumors.
Any severe systemic disease(s).
Patients who have received intra-articular hyaluronic acid within the previous 6 months and/or intra-articular steroids or articular lavage in the target joint within the previous 3 months prior to their inclusion in the study.
Administration of glucosamine sulphate, chondroitin sulphate and diacerein within the 3 months prior to their inclusion in the study.
History of allergy or hypersensitivity to hyaluronic acid.
Participation in any clinical study in the last 3 months and any surgery scheduled in the next 8 months that can affect directly the result of the present study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual Analog Scale (VAS) Pain rating
Range of Motion (ROM) of Wrist/Elbow/Shoulder/Hip
All Adverse Events
SF-36
Range of Motion (ROM) of Wrist/Elbow/Shoulder/Hip
All Adverse Events |
Time Frame: At baseline (pre-intervention), 7days and 1 Month
At baseline (pre-intervention), 7D, and 1 Month
Through 6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Visual Analog Scale (VAS) Pain rating
|
At baseline (pre-intervention), 7days, 1 Month, 3 Months, 6 Months |
| SF-12 |
At baseline (pre-intervention), 7days, 1 Month, 3 Months, 6 Months |
Range of Motion (ROM) of Wrist/Elbow/Shoulder/Hip
|
At baseline (pre-intervention), 7days, 1 Month, 3 Months, 6 Months |
| American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment form |
At baseline (pre-intervention), 7days, 1 Month, 3 Months, 6 Months |
| FIHOA |
At baseline (pre-intervention), 7days, 1 Month, 3 Months, 6 Months |
| Change in Flexion-Abduction-External Rotation (FABER) Test |
At baseline (pre-intervention), 7days, 1 Month, 3 Months, 6 Months |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
16/05/2025 |
| 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 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
|
Title of Study An
Open-Label, Multicenter, Prospective Study to Evaluate the Safety and Performance
of Intra-Articular Hyaluronic Acid
(BIOVISC ORTHO) in the Management of Wrist, Elbow, Shoulder and Hip Joint
Disorders Study Design Prospective,
Open-label, multi-center clinical study to evaluate safety and performance of
BIOVISC ORTHO in wrist, elbow, shoulder
and hip joint. Number of Subjects 96 Subjects Objective Assess
the safety and performance of BIOVISC ORTHO in patients with disorders in
wrist, elbow, shoulder and hip joint.
|