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

Tien-Ching Lee80 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rotator Cuff Lesions

Interventions

Hyaluronic acid, HADIETARY_SUPPLEMENT

improve tissue repair

Eligibility

Sex: ALLMin age: 20 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Kaohsiung Medical University Hospital

Kaohsiung City, Sanmin, Taiwan

RECRUITING

Outcomes

Primary Outcomes

Constant-Murley Shoulder Score (CMSS)

The Constant-Murley Shoulder Score (CMSS) is a multi-item functional scale assessing pain, ADL, ROM, and strength of the affected shoulder. score: 0-100. The higher score means the function feels good and painless.