Unique ID issued by UMIN | UMIN000027847 |
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Receipt number | R000031905 |
Scientific Title | Measurement of the penetration effect of S-flurbiprofen into the knee joint cavity by epidermis-sticking external preparation for patients with osteoarthritis |
Date of disclosure of the study information | 2017/06/21 |
Last modified on | 2017/06/21 11:45:20 |
Measurement of the penetration effect of S-flurbiprofen into the knee joint cavity by epidermis-sticking external preparation for patients with osteoarthritis
Measurement of penetration effect of S-flurbiprofen into the knee joint cavity
Measurement of the penetration effect of S-flurbiprofen into the knee joint cavity by epidermis-sticking external preparation for patients with osteoarthritis
Measurement of penetration effect of S-flurbiprofen into the knee joint cavity
Japan |
Osteoarthritis of the knee
Orthopedics |
Others
NO
To investigate the penetration effect of S-flurbiprofen into the knee joint cavity by epidermis-applied external preparation for patients with osteoarthritis.
Efficacy
S - flurbiorofen lumber for external use (containing S - flurbiorofen 40 mg) 12 hours before the start of surgery to the knee joint on the scheduled side of the target patient. Just before surgery, external lumber is removed, joint fluid of bilateral knee joints is collected under spinal anesthesia, and blood sampling is performed from the cranial vein of the upper arm. Measurement of the concentration of S-flurbiprofen in the harvested synovial fluid and plasma.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
S - flurbiorofen lumber for external use (containing S - flurbiorofen 40 mg) 12 hours before the start of surgery to the knee joint on the scheduled side of the target patient. Just before surgery, external lumber is removed, joint fluid of bilateral knee joints is collected under spinal anesthesia, and blood sampling is performed from the cranial vein of the upper arm. Measurement of the concentration of S-flurbiprofen in the harvested synovial fluid and plasma.
50 | years-old | <= |
80 | years-old | > |
Male and Female
(1) To recognize the change of grade 2 or more in Kellgren-Lawrence classification in knee X-ray photography. (2) It is not neuropathic arthropathy. (3) No arthritis caused by factors other than osteoarthritis (rheumatoid arthritis etc.) is not merged. (4) To meet adaptation criteria for knee replacement surgery in the OARSI recommendation on the management of osteoarthritis of the osteoarthritis (end of adaptation by the committee for formulation of guideline for knee osteoarthritis of the Japanese Orthopedic Society). (5) There is no operation history on the knee joint in the past. (6) The age at the time of case registration is 50 years old and under 80 years old.
Patients complicated with arthritis (rheumatoid arthritis etc.) caused by factors other than osteoarthritis.
100
1st name | |
Middle name | |
Last name | Massao Akagi, MD PhD |
Kindai University Hospital
Department of Orthopaedic Surgery
377-2 Ohno-Higashi, Osaka-Sayama City, Osaka, 589-8511, Japan
072-366-0221
makagi@med.kindai.ac.jp
1st name | |
Middle name | |
Last name | Ichiro Tsukamoto, MD |
Kindai University Hospital
Department of Orthopaedic Surgery
377-2 Ohno-Higashi, Osaka-Sayama City, Osaka, 589-8511, Japan
072-366-0221
tsukamoto@med.kindai.ac.jp
Kindai University
Self funding
Self funding
NO
近畿大学医学部附属病院
2017 | Year | 06 | Month | 21 | Day |
Unpublished
Preinitiation
2021 | Year | 06 | Month | 21 | Day |
2021 | Year | 07 | Month | 20 | Day |
2017 | Year | 06 | Month | 21 | Day |
2017 | Year | 06 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031905
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