CTRI/2021/11/038075Not yet recruiting未知
A prospective, randomized, clinical study comparing the clinical outcomes following intraarticular injection of either platelet rich plasma or bone marrow concentrate for knee osteoarthritis.
Department Of Orthopaedics0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- 未知
- Status
- Not yet recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •Age between 35 and 75 years-old
- •Diagnosis of pre-existing osteoarthritis of the joint by Kellgren-Lawrence Grade 1, 2 or 3.
- •Vas Score between 40 to 80.
- •Working understanding of the English language and able to fully understand the procedure
- •Capable of providing informed consent
- •Able to complete online, in-person or phone surveys for the purposes of follow-up
- •Capable of understanding pre- and post-procedure care instructions
- •Ambulatory at baseline
- •Previous trial and failure of conservative therapy consisting of a minimum of 6 weeks of physical therapy and trial of anti-inflammatory medications if not contraindicated, with or without concomitant bracing and/or injections.
Exclusion Criteria
- •Age < 35 or > 75 years old
- •MRI demonstrating either no or severe osteoarthritis (Kellgren-Lawrence Grade 0,4)
- •Prior total or partial joint replacement surgery or a surgery involving cartilage regeneration (microfracture, ACI, etc.)
- •Previous cortisone and/or Hyaluronic acid intra-articular injection or arthroscopic procedure within the last 3 months
- •Co-morbidity with autoimmune disease including rheumatologic condition, inflammatory arthritis
- •Chronic disease or medical condition such as cancer, cardiac conditions including CHF NYHA class 2 or worse, liver failure, renal failure including CKD grade 3 or worse, respiratory disease such as COPD and pulmonary fibrosis, clotting/coagulation disorder or Thrombocytopenia with <150,000 platelets per mm3.
- •Currently undergoing immunomodulatory therapy or otherwise immunosuppressedUncontrolled endocrine disorder
- •Current diagnosis of osteomyelitis, human immunodeficiency virus (HIV-1, -2) and/or hepatitis C (HCV), infection and poorly controlled diabetes (HgA1C >7.0)
- •Pregnancy or planned pregnancy
- •previous stem cell injection into treatment joint
- •Patient scheduled to undergo any concomitant surgical procedures.
- •Coagulopathy or anticoagulant treatment
- •Fibromyalgia, chronic fatigue or chronic pain involving multiple body parts or opioid medication management
- •Active or recent (within 2 weeks) history of infection
- •Neuromuscular disease
Investigators
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