JPRN-jRCTs031220227
Recruiting
Phase 2
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
SHITARA HITOSHI0 sites20 target enrollmentJuly 28, 2022
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- SHITARA HITOSHI
- Enrollment
- 20
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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