Rotator Cuff Lesions
Conditions
Keywords
rotator cuff lesions
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
Interventions
DIETARY_SUPPLEMENTHyaluronic acid, HA
improve tissue repair
Sponsors
Tien-Ching Lee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Constant-Murley Shoulder Score (CMSS) | before treatment, 4-week, 12-week, 24-week. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| American Shoulder and Elbow Surgeons (ASES) Score | before treatment, 4-week, 12-week, 24-week. | The American Shoulder and Elbow Surgeons Shoulder Score (ASES) was created by the Society of the American Shoulder and Elbow Surgeons in 1994 as a tool that applies to all shoulder diagnoses. score: 0-100. The higher score means the function feels good and painless. |
| range of motion of shoulder | before treatment, 4-week, 12-week, 24-week. | ROM: flex, extension, abduction, adduction, internal rotation, external rotation. degree: 0-180. The higher degree means the shoulder rotation extends good and is painless. |
| pain score (VAS) | before treatment, 4-week, 12-week, 24-week. | score 0-10. The lower score means the function feels good and painless. |
| the change of anatomy | before treatment, 4-week, 12-week, 24-week. | Echo or MRI\_Measure the wound size of rotator muscle rupture and confirm whether the wound has healed |
| associated complications | before treatment, 4-week, 12-week, 24-week. | infection, surgery, hypertrophic scar, consistent pain, etc. After the trial, the investigators calculate the rate of these complications. |
Countries
Taiwan
Outcome results
None listed