Patients with osteoarthritis of the knee
Conditions
Interventions
Limitations on the number of doses of intra-articular injections of purified sodium hyaluronate
Sponsors
Sato Masato
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients aged between 20 and 90 years at the time of obtaining consent, for whom written consent can be obtained in person 2)Patients with osteoarthritis of the knee diagnosed as grade 2-4 in K-L grade by simple radiography in the standing frontal weightbearing position including Rosenberg view. 3)Patients meeting NRS>= 4 at the index knee joint on most days of week since last three months in the pre-start assessment. 4)Patients scheduled for treatment of osteoarthritis of the knee with ARTZ Dispo 25mg intra-articular injection for five consecutive doses
Exclusion criteria
Exclusion criteria: 1)osteoarthritis of the knee with NRS > 4 present in the non-target knee joint 2)Patients with inflammatory joint disease other than osteoarthritis [rheumatoid arthritis, psoriatic arthritis, gout, pseudogout, systemic lupus erythematosus (SLE), Behcet's disease, reactive arthritis, polymyositis or other inflammatory diseases secondary to knee arthritis] as judged by the principal investigator. If necessary, the investigators will perform the necessary tests to rule out systemic inflammatory diseases. 3)Patients with lesions identified on MRI imaging that require treatment (e.g. dorsal root tear of the medial meniscus). 4)Patients with a history of surgery on the target knee (e.g. osteosynthesis, meniscus surgery, ligament reconstruction surgery, osteotomy, microfracture) 5)Patients with idiopathic osteonecrosis (SONK) or steroidal osteonecrosis. 6)Patients with traumatic cartilage defects or osteochondritis dissecans. 7)Patients with a history of hyaluronic acid therapy to the knee joint within one month prior to enrollment. 8)Patients with a history of steroids to the knee joint within 3 months prior to enrollment 9)Patients with a history of intra-articular knee administration of PRP or stem cells, culture supernatants, exosomes or other cellular products in the target knee. 10)Patients with psychiatric disorders, including depression (Center for Epidemiologic Studies Depression Scale (hereafter CES-D) >= 26 points), or patients whose doctor determines that they have neuropathic pain (PainDETECT score >= 19 points) with severe or unstable symptoms. 11)Opioid-dependent patients. 12)Pregnant women, lactating women and patients of childbearing potential. 13)Other patients deemed ineligible by the principal investigator or others.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in JKOOS Pain Subscale at 12 months after the start of the first dose from before the start of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| validity assessment 1)Change from baseline in JKOOS Subscale (Pain , Symptom, ADL, Sport/Recreation, QOL) and change from baseline in JKOOS 4 (excluding Sport/Recreation) at each assessment 2)Change in JKOOS Pain Subscale (Pain, Symptom, ADL, Sport/Recreation, QOL) at end/discontinuation from baseline 3)Changes in NRS after initiation of treatment. 4)Changes in K-L grade after the start of treatment 5)For study subjects for whom MRI imaging was obtained, the status of cartilage, bone marrow abnormalities, bone cysts, bone wear, osteophytes, meniscus, ligaments and synovitis of the knee joint is assessed from 14 items using the Whole-Organ Magnetic Resonance Imaging Score (WORMS) Safety assessment 1)Frequency and nature of adverse events | — |
Contacts
Public ContactMasato Sato
Tokai University Hospital
Outcome results
None listed