G-CSF for Promotion of Rotator Cuff Healing

JRCT ID: jRCTs031220100

Registered date:30/05/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Rotator cuff tear
• Date of first enrollment: 28/11/2022
• Target sample size: 15
• Study type: Interventional

Intervention(s)

Filgrastim
Once a day for 5 days subcutaneously

Outcome(s)

• Primary Outcome: Rotator cuff retear rate using MRI by Sugaya classification at 3 months after surgery

Secondary Outcome

At 3 months after surgery,
A) Pain assessment: NRS, Analgesic consumption, Central Sensitization Inventory (CSI, Japanese version), and PainDETECT (Japanese version)
B) Functional assessment: Japanese Orthopaedic Association (JOA) score for shoulder joint disease, Constant score, range of motion and muscle strength of shoulder joint
C) Patient-standing type functional assessment: Japanese version of Disability of the Arm, Shoulder, and Hand (DASH) and ASES score
D) QOL assessment: Japanese version of EQ-5D (EuroQol 5 Dimension)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 65age old
• Gender: Both

Include criteria

(1) Between 20 and 65 years old.
(2) Subjects who have a diagnosed with rotator cuff tears.
(3) Subjects whose tears are classified as middle size tears and greater than that by the Cofield's classification.
(4) Subjects who are scheduled to undergo arthroscopic shoulder rotator cuff repair.
(5) Subjects who have given written consent to participate in this study.

Exclude criteria

1) Subjects who are hypersensitive to the components of the study drug or other granulocyte colony-forming stimulating factor products.
2) Subjects with myelogenous leukemia in which the number of blasts in the bone marrow is not sufficiently reduced, and research subjects with myelogenous leukemia in which myeloid blasts are observed in the peripheral blood.
3) Subjects with a history of drug hypersensitivity.
4) Subjects with a predisposition to allergy.
5) Subjects who require continuous anticoagulant medication during the perioperative period.
6) Subjects with splenomegaly.
7) Subjects with complications or history of maliglant tumors.
8) Subjects who are pregnant.
9) Subjects who are lactating.
10) Subjects with a history of thrombosis.
11) Subjects with a history of coronary artery disease or cerebrovascular disease.
12) Subjects with cardiac, pulmonary, renal, or hepatic disease requiring treatment.
13) Subjects with abnormal laboratory values requiring treatment or close examination.
14) Subjects with autoimmune diseases.
15) Subjects with neurological diseases.
16) Subjects with uncontrolled hypertension (resting systolic > 160 mmHg or diastolic > 100 mmHg).
17) Subjects with uncontrolled hyperlipidemia (total cholesterol > 240 mg/dL, except for LDL-C < 140 mg/dL).
18) Subjects with diabetes mellitus requiring medication (fasting blood glucose > 125 mg/dL or anytime blood glucose > 200 mg/dL).
19) Subjects with complications or history ofinterstitial pneumonia.
20) Subjects with contraindications to MRI imaging.
21) Other subjects who are judged by a physician to be inappropriate for the subject.

Related Information

• Primary Sponsor: Shitara Hitoshi
• Secondary Sponsor: Chikuda Hirotaka