Comparison of Steroid, PRP,and PRP Plus Hyaluronic Acid Injection for Rotator Cuff Lesions.

Tien-Ching Lee

Status: Enrolling

Conditions: Rotator Cuff Lesions

Treatments: Dietary Supplement: Hyaluronic acid, HA

Study type: Interventional

Funder types: Other

Identifiers

NCT06237647

RCT-002

Details and patient eligibility

About

Rotator cuff tear is a common cause of shoulder pain. Steroids, hyaluronic acid (HA), and platelet-rich plasma (PRP) injections are becoming popular for the treatment of chronic rotator cuff partial tear. The investigators plan to evaluate the effect of the new product of PRP combined with HA on the rotator cuff and prove its benefit of pain control and function recovery.

Full description

Rotator cuff tear is a common cause of shoulder pain. Steroids, hyaluronic acid (HA), and platelet-rich plasma (PRP) injections are becoming popular for the treatment of chronic rotator cuff partial tear. The investigators plan to evaluate the effect of the new product of PRP combined with HA on the rotator cuff and prove its benefit of pain control and function recovery.

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

Enrollment: 80 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A. Shoulder pain for at least 1 months
• B.partial-thickness tear diagnosed by MRI or Echo
• C.age between 20 and 85 years old

Exclusion criteria

• A. inflammatory disease, such as rheumatoid arthritis, SLE, etc.
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

PRP+HA

Experimental group

Description:

5mL of PRP+HA

Treatment:

Dietary Supplement: Hyaluronic acid, HA

PRP injection

No Intervention group

Description:

4mL of PRP added 1 mL of lidocaine

Steroid

No Intervention group

Description:

1 mL of rinderon added 4 mL of lidocaine

PROLOTHERAPHY

Experimental group

Description:

4 mL of 20% dextrose added1 mL lidocaine

Treatment:

Dietary Supplement: Hyaluronic acid, HA