Knee Osteoarthritis
Conditions
Interventions
Case series:Intra-articular injection of 2ml cytoactive factors in patients with knee osteoarthritis
Sponsors
Hefei Southeast Orthopedics Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Aged > 18 years old male and female; 2) Meet the diagnostic criteria for knee osteoarthritis; 3) Ability to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1) History of surgery, or major trauma ,or fracture to the study joint; 2) Significantly incapacitated or disabled and would be categorized as ACR Functional Class IV (largely or wholly incapacitated), or unable to walk without assistive devices; 3) Congenital or acquired malformation resulting in significant deformity of the knee (varus<10o; valgus<20o) and leading to problems in application or evaluation of results; 4) The subject has complications or diseases of: systemic or rheumatoid arthritis, Chondrocalcinosis articular Hemochromatosisinflammatory arthropathyavascular necrosis of femoral headPaget's diseasehemophilic arthropathyinfectional arthritisCharcot's diseasevillonodular synovitis or synovial chondromatosis; 5) The subject has coagulation disorders, or poor controlled diabetes or other contraindications that affect cartilage repair; 6) Patient has uncontrolled alcohol or substance abuse within 6 months of randomization; 7) Patient has any underlying or current medical or psychiatric condition that, in the opinion of the Investigator, would interfere with the evaluation of the subject; 8) Patient with uncontrolled bacterial, viral or fungal infection, including hepatitis A, hepatitis B, hepatitis C, HIV, and syphilis positive; 9) Severe cardiac insufficiency, such as the left ventricular ejection rate < 50%, or right ventricular failure or arrhythmias; 10) No uncontrolled hypertension or congestive heart failure, active angina pectoris requiring the use of nitrates, myocardial infarction within the past 6 months, or major ventricular arrhythmia or cardiac failure requiring active treatment; 11) Patient with pulmonary hypertension; 12) Patient with diffuse alveolar hemorrhage and other progressive lung diseases may need to use masks or other auxiliary machinery to maintain blood oxygen concentrations; Hypoxemia, blood oxygen saturation <90 %; 13) Severe or symptomatic restrictive or obstructive lung disease or respiratory failure requiring ventilator support; 14) Severe liver dysfunction, alanine aminotransferase and total bilirubin level is more than 3 times the normal level; 15) Severe hepatic veno-occlusive disease (VOD) or sinusoidal obstruction; 16) Severe renal insufficiency, Creatinine levels are more than 2 times higher than normal levels; 17) Women who are pregnant or intend to become pregnant or breast-feeding; 18) Participation in another clinical trial; 19) Severe allergies, known hypersensitivity to Hyaluronan products; 20) Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WOMAC Osteoarthritis index score;Knee joint injury cartilage morphology; | — |
Countries
China
Contacts
Public ContactHu Da-Yong
Hefei Southeast Orthopedics Hospital
Outcome results
None listed