Comparison of Steroid, PRP,and PRP Plus Hyaluronic Acid Injection for Rotator Cuff Lesions.
NCT ID: NCT06237647
Last Updated: 2025-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2023-02-17
2027-12-31
Brief Summary
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Detailed Description
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1. Name: Cellular matrix™ PRP-HA
2. Dosage form: Cellular Matrix A-CP-HA Kit (Ref. A-CP-HA-3)
3. Dose(s): 3 mL of platelet-rich plasma (PRP) combined with 2 mL of hyaluronic acid
4. Dosing schedule: one injection. After collecting 6 mL of blood collection and then centrifugation for 5 minutes, the PRP with a platelet concentration 1.5-1.6 times higher than the baseline in blood, deprived of contamination with red and white blood cells, entrapped in a 3D network of HA
5. Mechanism of action: PRP contains rich growth factors and HA could function as bio-scaffold. They have a synergic effect on tissue repair.
6. Pharmacological category: class III medical device
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PRP+HA
5mL of PRP+HA
Hyaluronic acid, HA
improve tissue repair
PRP injection
4mL of PRP added 1 mL of lidocaine
No interventions assigned to this group
Steroid
1 mL of rinderon added 4 mL of lidocaine
No interventions assigned to this group
PROLOTHERAPHY
4 mL of 20% dextrose added1 mL lidocaine
Hyaluronic acid, HA
improve tissue repair
Interventions
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Hyaluronic acid, HA
improve tissue repair
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* B.partial-thickness tear diagnosed by MRI or Echo
* C.age between 20 and 85 years old
Exclusion Criteria
* B. pregnancy
* C. known malignancy
* D. hematologic disease (or hemoglobin \<10 g/dl, platelet \<150.000 ul)
* E. history of shoulder infection
* F. history of shoulder surgery
* G. prior steroid injection for 3 times or more
* H. full-thickness tear
* I. other shoulder problems, such as osteoarthritis, fracture malunion, etc.
* J. subjects who cannot comply with the protocol of study
* K. The shoulder pain area has been treated with PRP for less than 3 months
20 Years
85 Years
ALL
No
Sponsors
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Tien-Ching Lee
OTHER
Responsible Party
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Tien-Ching Lee
Department of Orthopaedics
Locations
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Kaohsiung Medical University Hospital
Kaohsiung City, Sanmin, Taiwan
Countries
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Facility Contacts
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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RCT-002
Identifier Type: -
Identifier Source: org_study_id
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