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

Phase 2

Recruiting

• Conditions: Rotator cuff tear; rotator cuff tear, shoulder

• Registration Number: JPRN-jRCTs031220227
• Lead Sponsor: SHITARA HITOSHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified