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

NCT ID: NCT06237647

Last Updated: 2025-03-05

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-17

Study Completion Date

2027-12-31

Brief Summary

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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

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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

Conditions

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Rotator Cuff Lesions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PRP+HA

5mL of PRP+HA

Group Type EXPERIMENTAL

Hyaluronic acid, HA

Intervention Type DIETARY_SUPPLEMENT

improve tissue repair

PRP injection

4mL of PRP added 1 mL of lidocaine

Group Type NO_INTERVENTION

No interventions assigned to this group

Steroid

1 mL of rinderon added 4 mL of lidocaine

Group Type NO_INTERVENTION

No interventions assigned to this group

PROLOTHERAPHY

4 mL of 20% dextrose added1 mL lidocaine

Group Type EXPERIMENTAL

Hyaluronic acid, HA

Intervention Type DIETARY_SUPPLEMENT

improve tissue repair

Interventions

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Hyaluronic acid, HA

improve tissue repair

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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glucose

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tien-Ching Lee

OTHER

Sponsor Role lead

Responsible Party

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Tien-Ching Lee

Department of Orthopaedics

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Kaohsiung Medical University Hospital

Kaohsiung City, Sanmin, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Facility Contacts

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Lee Tien-Ching, ph.d.

Role: primary

+886-7-3121101 ext. 2553

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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RCT-002

Identifier Type: -

Identifier Source: org_study_id

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