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Clinical study on safety assessment of PRP therapy for iliopsoas impingement after total hip arthroplasty(PRP for illiopsoas impingement) (PRP for iliopsoas impingement)

Clinical study on safety assessment of PRP therapy for iliopsoas impingement after total hip arthroplasty(PRP for illiopsoas impingement) (PRP for iliopsoas impingement)

Takahashi Kazuhisa

Jan. 20, 2021

3

3 cases of psoas impingement after total hip arthroplasty (65 yrs old female,69 yrs old female,77yrs old male.).

Planned as a safety study,and perfomred for three cases.

No serious adverse evend,no occurrence of diseases related to regenerative medicine.

Primary endpoint : No serious adverse events. Secondary endpoint : At Pre/2 weeks/ 4 weeks/ 8 weeks/ 12 weeks after the injection,JHEQ: Case 1:63.1/61.9/67.9/61.9/69.0, Case 2:51.2/75.0/86.9/85.7/78.6, Case 3:28.6/34.5/27.4/26.2/32.3. FJS-12 scale: Case 1:52.1/54.2/62.5/66.7/72.9,Case 2:56.8/61.4/56.8/61.4/61.4,Case 3:29.5/34.1/36.4/52.1/43.8.

Safety of PRP for psoasimpingement after total hip arthroplasty was demosntrated.

Mar. 31, 2023

https://jrct.mhlw.go.jp/latest-detail/jRCTb030190272

Homma Yasuhiro

Juntendo Hospital, Juntendo university school of medicine

3-1-3, Hongo, Bunkyo-ku, Tokyo, Japan

yhomma@juntendo.ac.jp

Masubuchi Yosuke

Juntendo university

2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan

+81-3-3814-5672

y-masubuchi@juntendo.ac.jp

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1.Patients who have symptoms for more than 3 months
2.Patients who have continued pain even after taking NSAIDs for 6 week or more and who can not use NSAIDs for asthma and digestive tract ulcer
3. More than 20 years old
4. Other , patients who the doctor has determined that it is suitable for this clinicalstudy

1. Patients with abnormal platelet counts in peripheral blood
2. Person who smokes a lot(Brinkmanindex>600)
3. Treatment with anticoagulants(Warfarin)
4. Uncontrolled diabetes mellitus :HbA1c not lower than 9.0% according to latest laboratory data obtained within 14 days before registration
5. Patients with malignancy
6. Patients less than 6 months after onset of cardiac infarction or cerebral infarction
7. Predictive survival period is less than 1 year
8.Active infectious disease (HBV, HCV, HTLV-1, HIV, syphilis)
9.Dialysis patients
10. Compromised host
11. Requiring continued use of oral corticosteroid therapy
12. Less than 20 years old
13. Doctor has determined that it is not suitable for this clinical study

Both

Patients who is diagnosed iliopsoas impingement after total hip arthroplasty

administration of cell processing products.

safety

efficacy

Complete

+81-3-5803-4162

Mar. 14, 2019