Enhancement of healing after arthroscopic rotator cuff repair by PFC-FD(Platelet-Derived Factor Concentrate Freeze Dry)

JRCT ID: jRCTs031220227

Registered date:28/07/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Rotator cuff tear
• Date of first enrollment: 18/11/2022
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Administration of PFC-FD into the subacromial bursa and the glenohumeral joint

Outcome(s)

• Primary Outcome: Evaluation of rotator cuff re-tear rate by Sugaya classification at 3 months postoperatively

Secondary Outcome

At 3 months after the surgery
1) Pain assessment
a. NRS
b. Analgesic consumption
c. Japanese version of Central Sensitization Inventory (CSI)
d. Japanese version of PainDETECT
2) Functional assessment
a. Japanese Orthopaedic Association Shoulder Disease Outcome Criteria (JOA score)
b. Constant score
c. Joint range of motion
d. Muscle strength
3) Patient-oriented functional assessment:
a. Japanese version (Disability of the Arm, Shoulder, and Hand) DASH
b. ASES score
4) Quality of life assessment
a. Japanese version of EQ-5D ( EuroQol 5 Dimension )

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) 20 years old and older
(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 with preoperative platelets < 150,000 microliters
2) Subjects with hematologic disorders or coagulopathy
3) Subjects who need to continue anticoagulants (anticoagulants) in the perioperative period
4) Subjects with tumors
5) Subjects who are infected with various blood disease viruses (HBV/HCV/HIV/HTLV-1)
6) Subjects who have received PRP or PFC-FD therapy to the same area within 3 months
7) Subjects who are pregnant
8) Subjects who are breast-feeding
9) Subjects with contraindications to MRI imaging
10) Other subjects who are judged as inappropriate subjects by the physician

Related Information

• Primary Sponsor: SHITARA HITOSHI
• Secondary Sponsor: Chikuda Hirotaka
• Source(s) of Monetary Support: CellSource Co., Ltd.