A Post Marketing Surveillance Study of INVOSSA K Inj.

Study Overview
=================
Brief Summary
-----------------
This study is post-marketing surveillance of Invossa K injection in patients with osteoarthritis.

Official Title
-----------------
Post Marketing Surveillance on Safety and Effectiveness Evaluation of INVOSSA K Inj.

Conditions
-----------------
Osteoarthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients over 19 years Patients who diagnosed with osteoarthritis will plan to INVOSSA K Inj. injection and suitable for following criteria : - Moderate knee osteoarthritis (Kellgren & Lawrence grade 3) with persistent symptoms (pain, etc.) in spite of conservative therapy (medication, physical therapy, etc.) for more than 3 months Patients (or substitute) who is provided all information regarding participation of this PMS signed the informed consent form Exclusion Criteria: Pregnant or breastfeeding female Patients who have administered corticosteroid before INVOSSA K Inj. injection within the past 30 days Patients who have severe disease such as heart, liver, kidney disease or other severe complications Patients who rheumatoid arthritis, gouty arthritis, autoimmune disease associated arthritis except for osteoarthritis Patients with a medical history of allergic diseases or patients with a medical history of anaphylactic reactions (including patients with a history of hypersensitivity reactions to the components of this drug, including dimethylsulfoxide (DMSO), mannitol, dextran 40 or bovine proteins) Patients who have been treated with injections to the target knee within the past three months or patients with a past history of surgery, including arthroscope, within the past six months Patients currently with leukemia or malignant tumors such as osteochondroma, chondroblastoma, cartilaginous mucinous fibrous tumor, chondroma and chondrosarcoma, which may be exacerbated by administration of INVOSSA-K inj. or patients with a history thereof Patients with Kellgran & Lawrence grade 4 osteoarthritis

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AEs (Adverse Events) | Changes of incidence rate in AEs | 0 month(visit 1), 1 month(visit 2) and 6 Months(visit 3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 100 mm VAS (Visual Analog Scale) | Changes of 100 mm VAS at each visit (Scale : 0 100, 0 : No pain, 100 : Worst imaginable pain) | 0 month(visit 1), 1 month(visit 2) and 6 Months(visit 3) | 
| Physical examination (Knee joint swelling) | Changes of Knee joint swelling at each visit | 0 month(visit 1), 1 month(visit 2) and 6 Months(visit 3) | 
| Physical examination (Tenderness) | Changes of tenderness at each visit | 0 month(visit 1), 1 month(visit 2) and 6 Months(visit 3) | 
| Physical examination (ROM) | Changes of ROM(Range Of Motion) at each visit | 0 month(visit 1), 1 month(visit 2) and 6 Months(visit 3) | 
| General efficacy evaluation | General efficacy evaluation was assessed by following 4 criteria. (Improved, Not changed, Worsened, Unassessable) | 6 Months(visit 3) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chondrocyte cells, osteoarthritis, gene therapy