CTRI/2021/11/038075
Not 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 enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: M171- Unilateral primary osteoarthritisof knee
- Sponsor
- Department Of Orthopaedics
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
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
Outcomes
Primary Outcomes
Not specified
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