To evaluate the Safety and Performance of Intra-Articular Hyaluronic Acid (HA)(BIOVISC ORTHO) in Patients with wrist/elbow/shoulder/Hip joint disorder(s)

Not Applicable

Not yet recruiting

• Conditions: Pain in joint,

• Registration Number: CTRI/2025/05/086494
• Lead Sponsor: BIOTECH VISION CARE PVT. LTD

Brief Summary

**Title of Study**AnOpen-Label, Multicenter, Prospective Study to Evaluate the Safety and Performanceof  Intra-Articular Hyaluronic Acid(BIOVISC ORTHO) in the Management of Wrist, Elbow, Shoulder and Hip JointDisorders

**Study Design**Prospective,Open-label, multi-center clinical study to evaluate safety and performance ofBIOVISC ORTHO  in wrist, elbow, shoulderand hip joint.

**Number** **of** **Subjects** 96 Subjects

**Objective**Assessthe safety and performance of BIOVISC ORTHO in patients with disorders inwrist, elbow, shoulder and hip joint.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-05-05
• Study Start: 2025-05-16

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS) Pain rating	Time Frame: At baseline (pre-intervention), 7days and 1 Month | At baseline (pre-intervention), 7D, and 1 Month | Through 6 Months
SF-36	Time Frame: At baseline (pre-intervention), 7days and 1 Month | At baseline (pre-intervention), 7D, and 1 Month | Through 6 Months
Range of Motion (ROM) of Wrist/Elbow/Shoulder/Hip	Time Frame: At baseline (pre-intervention), 7days and 1 Month | At baseline (pre-intervention), 7D, and 1 Month | Through 6 Months
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 Measures

Name	Time	Method
American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment form	At baseline (pre-intervention), 7days, 1 Month, 3 Months, 6 Months
Visual Analog Scale (VAS) Pain rating
SF-12	At baseline (pre-intervention), 7days, 1 Month, 3 Months, 6 Months
Range of Motion (ROM) of Wrist/Elbow/Shoulder/Hip
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

Trial Locations

Locations (2)

Matis Multi Speciality Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Pushpam Superspeciality Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Matis Multi Speciality Hospital

🇮🇳Ahmadabad, GUJARAT, India

Dr Shrey Desai

Principal investigator

9722280170

shreydesai1995@gmail.com