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

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031220227

Enrollment

Registered

2022-07-28

Start date

2022-11-18

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator cuff tear rotator cuff tear, shoulder

Interventions

Administration of PFC-FD into the subacromial bursa and the glenohumeral joint

PFC-FD, PRP

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Evaluation of rotator cuff re-tear rate by Sugaya classification at 3 months postoperatively	—

Secondary

Measure	Time frame
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 )	—

Measure

Time frame

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 )

—

Contacts

Public ContactHITOSHI SHITARA

Gunma University Hospital

hshitara@gunma-u.ac.jp+81-272208269

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026