Comparison of Effect of Adalimumab versus Hyaluronic Acid in Knee Osteoarthritis
Phase 4
- Conditions
- Health Condition 1: null- Primary Osteoarthritis of the Knee
- Registration Number
- CTRI/2018/09/015662
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. 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 VASTimepoint: 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 ScaleTimepoint: 4 weeks and 12 weeks post injection