Comparison of Steroid, PRP,and PRP Plus Hyaluronic Acid Injection for Rotator Cuff Lesions.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hyaluronic acid, HA.
- Who it may be relevant to
- Registry conditions: Rotator Cuff Lesions. Basic parameters: 20 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Steroid, Platelet-rich Plasma and Platelet-rich Plasma Plus Hyaluronic Acid Injection for Rotator Cuff Lesions
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.
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
Interventions
- Dietary supplement Hyaluronic acid, HA
improve tissue repair
Primary outcome measures
- Constant-Murley Shoulder Score (CMSS) [Time frame: before treatment, 4-week, 12-week, 24-week.]
Secondary outcome measures (5)
- American Shoulder and Elbow Surgeons (ASES) Score [Time frame: before treatment, 4-week, 12-week, 24-week.]
- range of motion of shoulder [Time frame: before treatment, 4-week, 12-week, 24-week.]
- pain score (VAS) [Time frame: before treatment, 4-week, 12-week, 24-week.]
- the change of anatomy [Time frame: before treatment, 4-week, 12-week, 24-week.]
- associated complications [Time frame: before treatment, 4-week, 12-week, 24-week.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- Kaohsiung Medical University Hospital — Kaohsiung City
Identifiers
NCT: NCT06237647 · RCT-002