Effectiveness of Injections into the knee joint like Platelet Rich Plasma with (Hyaluronic Acid) Gel in comparison with Botulinum Toxin type A (Derived from Bacteria) with (Hyaluronic Acid) Gel in reducing Knee pain and improving function of Knee in cases of degenerative disease of Knee.
Phase 3
- Conditions
- Health Condition 1: M170- Bilateral primary osteoarthritis of knee
- Registration Number
- CTRI/2023/07/055477
- Lead Sponsor
- Dr Shubha V Hegde
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Bilateral Knee Osteoarthritis Grade 3 and 4.
2.Knee pain > 3 months.
3.Morning stiffness < 30 minutes.
Exclusion Criteria
1.Patient’s unwillingness to participate.
2.History of other diseases affecting knee joint like Rheumatoid Arthritis, Gout, Neuromuscular diseases.
3.Previous intra-articular injections.
4.History of knee joint surgery.
5.Acute Trauma.
6.Contraindications to intra-articular injection e.g., sepsis, intra-articular infections, intra-articular fracture, or uncontrolled coagulopathy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To evaluate the efficacy of intra- articular Platelet rich plasma with Hyaluronic Acid (PRP with HA) in comparison with intra- articular Botulinum Toxin A with Hyaluronic Acid on knee pain. <br/ ><br> <br/ ><br>2.To evaluate the effect of intra- articular PRP with HA in comparison with intra- articular Botulinum Toxin A with Hyaluronic Acid on functional limitation of Knee. <br/ ><br> <br/ ><br>3.To assess the effect of patient factors post procedure, on knee pain & functional limitation .Timepoint: Pre- Procedural, Immediate post procedure, 2weeks, 4 weeks, 12 weeks and 24 weeks. <br/ ><br>
- Secondary Outcome Measures
Name Time Method To assess the effect of patient factors post procedure, on knee pain & functional limitation .Timepoint: Baseline, At the end of 24 weeks.