Clinical trial NCT06237647: Comparison of Steroid, PRP,and PRP Plus Hyaluronic Acid Injection for Rotator Cuff Lesions.
Official title: Comparison of Steroid, Platelet-rich Plasma and Platelet-rich Plasma Plus Hyaluronic Acid Injection for Rotator Cuff Lesions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rotator Cuff Lesions
Keywords: rotator cuff lesions
Lead sponsor: Kaohsiung Medical University
Sponsor class: OTHER
First posted: 2024-02-01
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Constant-Murley Shoulder Score (CMSS)
timeFrame: before treatment, 4-week, 12-week, 24-week.
Secondary outcomes:
measure: American Shoulder and Elbow Surgeons (ASES) Score
timeFrame: before treatment, 4-week, 12-week, 24-week.
measure: range of motion of shoulder
timeFrame: before treatment, 4-week, 12-week, 24-week.
measure: pain score (VAS)
timeFrame: before treatment, 4-week, 12-week, 24-week.
measure: the change of anatomy
timeFrame: before treatment, 4-week, 12-week, 24-week.
measure: associated complications
timeFrame: before treatment, 4-week, 12-week, 24-week.
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
state: Sanmin
Study officials:
References: