Comparison of Effect of Adalimumab versus Hyaluronic Acid in Knee Osteoarthritis

Phase 4

Recruiting

• Conditions: Primary Osteoarthritis of the Knee

• Registration Number: CTRI/2018/09/015662
• Lead Sponsor: All India Institute of Medical Sciences

Brief Summary

Although an Intra - Articular Injection of Hyaluronic Acid is commonly used for the treatment of Osteoarthritis of the knee, Adalimumab owing to its ability to downregulate the expression of pro - inflammatory cytokines and rate of synthesis of metalloproteinases has shown good results in inflammatory conditions. However, few attempts have been made to improve the treatment of patients with Knee OA by Intra -Articular Adalimumab.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-17
• Last Update Posted: 2019-04-07

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• Diagnosis of Knee OA as per 2016 ACR Revised Criteria for Early Diagnosis of Knee OA 2.
• Unilateral Primary OA of Grade 2 or Grade 3 on Kellgren Lawrence Scale 3.
• Pain Score >4 on VAS( Visual Analogue Scale) within the past one month 4.
• Lack of efficacy of previous treatment with Diclofenac at a dose of 75mg/day.

Exclusion Criteria

• 1. Previous treatment with TNF inhibitors 2. Previous Intra.
• Articular treatment within 3 months 3.Previous Knee Surgery 4. History of tumor or serious Infection 5. Pregnancy 6. Lactation 7. Cognitive Impairment 8. Previous history of trauma to the knee.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To Compare the Effect of a Single Ultrasound - Guided Intra - Articular Injection of Adalirec) mumab with a Single Ultrasound Guided Intra -Articular Injection of Hyaluronic Acid on Pain using VAS	4 weeks and 12 weeks post injection

Secondary Outcome Measures

Name	Time	Method
To Compare the Effect of a Single Ultrasound - Guided Intra - Articular Injection of Adalimumab with a Single Ultrasound Guided Intra -Articular Injection of Hyaluronic Acid on Pain, other Symptoms, Function in Daily Living(ADL), Function in Sport and Recreation(Sport/Rec) using KOOS Scale	4 weeks and 12 weeks post injection

Trial Locations

Locations (1)

AIIMS, New Delhi; 🇮🇳 West, DELHI, India

AIIMS, New Delhi

🇮🇳West, DELHI, India

Dr Abhimanyu Vasudeva

Principal investigator

9910185126

abhimanyu.vmmc@gmail.com