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This study evaluates the safety and efficacy of investigational products in the treatment of knee Osteoarthritis. Half of participants will receive medical chitosan, while the other half will receive sodium hyaluronate.
Medical chitosan and sodium hyaluronate each form the reticular layer to cover the joint surface, alleviate the joint friction and pain. For medical chitosan, its half-life is longer than sodium hyaluronate, so the interval time of intra-articular injection is longer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medical Chitosan | Experimental | Medical Chitosan, 2ml/vial (12mg/ml), intra-articular injection with a volume less than 2ml every two weeks, a total of 3 times |
|
| Sodium Hyaluronate Injection | Active Comparator | Sodium Hyaluronate Injection, 2ml/vial (10mg/ml), intra-articular injection with a volume less than 2ml every one weeks, a total of 5 times. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical Chitosan | Device | intra-articular injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale for knee pain | The investigator and the subject both evaluate the pain intensity per VAS before injection. VAS ranges from o to 10, 0=no pain, 10=pain as bad as can be. | six weeks of the initial injection |
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC for knee pain | WOMAC includes 3 items: pain, stiff and physiological function. 0=no, 4=as bad as can be. | six weeks of the initial injection |
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Inclusion Criteria:
Males or females at the age of 40-75 years old
Conforming to the diagnosis standard of the American College of Rheumatology in 2009: knee pain and osteophyte determined with X-ray, and at least one of the following items:
The studying knee has score of 40-90 mm on a 100 mm measured VAS and the other side was less than 40mm when walking on flat ground.
The studying knee has score of 1, 2 or 3 determined by radiological Kellgren-Lawrence grading scale.
Patients who have treatment requirements and can obey the therapeutic schedule
Body mass index(BMI) ≤35kg/m2。
Able to follow the clinical observation and follow up.
The subjects are able to understand and sign the informed consent after fully understand this study, the disease, investigational drugs, the therapeutic schedule and the potential risks.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Changqing Zhang, PhD | Contact | +86-13003104089 | zhangcq@sjtu.edu.cn | |
| Shengbao Chen, MD | Contact | +86-18930172088 | shengbaocheng@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Changqing Zhang, PhD | Shanghai,China.Shanghai Sixth People's Hospital. Orthopedics. Recruiting. No. 600. Yishan Rd. Shanghai. Post Code:200233. | Principal Investigator |
| Shigui Yan, PhD | Hangzhou,Chian. The Second Affiliated Hospital of Zhejiang University School of Medicine. Orthopedics. Not yet recruiting. No.88 Jiefang Road Hangzhou.China Post Code:310009 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Sixth People's Hospital. Orthopedics. | Recruiting | Shanghai | Shanghai Municipality | 200233 | China |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Sodium Hyaluronate Injection |
| Drug |
intra-articular injection |
|
| Principal Investigator |
| D012216 |
| Rheumatic Diseases |