Comparision between Intraarticular VersusSubchondral Bone Marrow Aspirate Concentrate BMAC Injection in Osteoarthritis Knee
Phase 2
- Conditions
- Health Condition 1: M170- Bilateral primary osteoarthritis of knee
- Registration Number
- CTRI/2024/04/065284
- Lead Sponsor
- Arulkumar Nallakumarasamy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients OA knee – Grade II and III.
Primary OA knee patients not responding to analgesics
Patients who are willing to take part in the study after informed consent
Exclusion Criteria
1) Post-traumatic knee Stiffness
2) History of Infective joint disease
3) Patients with a history of previous surgeries on the knee.
4) Co-morbid / Pathology of ipsilateral Hip/ foot joint pathology
•Patients with rheumatoid arthritis, inflammatory arthritis or polyarticular arthritis, and autoimmune diseases
5)Any other defect of the ipsilateral limb like – Shortening etc.
6)Patients with h/o prior corticosteroid injection at a treatment site within 3 months of duration
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess change in patient-reported outcome measures such as VAS, WOMAC, and KOOS, from baseline to different follow-up time pointsTimepoint: At post-procedure, 1 week, 1 months, 3 months, 6 months & 1 year
- Secondary Outcome Measures
Name Time Method To assess the healing of subchondral bone lesions (bone marrow lesions) & the integrity of cartilage during pre and post-procedural follow-up with intraarticular and subchondral BMAC in primary osteoarthritis knees via MOCART at a 1-year time point using MRI. <br/ ><br>Timepoint: 1 year