Rotator cuff tear
Conditions
Interventions
A:Immediately after the surgery is completed and the incision is sutured, one medical chitosan (specification: 2ml) is injected into the joint cavity and the subacromial space respectively.
B:Once the surgery is completed and the incision is sutured, immediately inject 1 vial of sodium hyaluronate into the joint cavity and the subacromial space (specification: 2.5 ml, draw 2 ml).
C:Immediately after completing the surgery and closing the incision, a placebo injection using an identical-looking empty needle was administered into the joint cavity and subacromial space.
Sponsors
Hospital of Chengdu University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Patients undergoing arthroscopic double-row suture anchor rotator cuff repair due to supraspinatus tendon injury. (2) Rotator cuff tear size between 1 cm and 3 cm. (3) Age between 40 and 70 years. (4) Poor response to conservative treatment after 3 months. (5) Significant symptoms such as pain and limited mobility, with a clear cause. (6) MRI scan (oblique coronal and oblique sagittal), and X-ray (supraspinatus outlet view) findings consistent with symptoms and signs. (7) Participants and their families have been informed of the nature of the study, understand the study requirements, have good compliance, and have signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients who refuse to participate in this study. (2) Patients with psychiatric disorders or poor compliance. (3) Patients with severe internal medical conditions that prevent surgery, such as severe cardiovascular or cerebrovascular diseases, coagulation disorders, or severe liver and kidney dysfunction. (4) Patients with uncontrolled or poorly controlled underlying diseases (such as diabetes or hypertension). (5) Patients with severe rotator cuff injuries that are irreparable. (6) Patients who have previously undergone invasive procedures on the affected shoulder. (7) Pregnant women and other special populations. (8) Patients with the affected shoulder also suffering from Hill-Sachs lesions, Bankart lesions, shoulder fractures, dislocation or shoulder instability, calcific tendinitis, shoulder tumors, infectious arthritis, rheumatoid arthritis, frozen shoulder, severe osteoporosis, or other types of shoulder joint diseases. (9) Patients allergic to any drugs involved in the trial. (10) Patients with elevated infection markers, such as routine blood tests, C-reactive protein, ESR, or procalcitonin, suggesting possible infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Shoulder range of motion(ROM); | — |
Secondary
| Measure | Time frame |
|---|---|
| Ratio of abductor muscle strength between affected and healthy shoulder;VAS;UCLA Score;ASES Score;Swelling level of shoulder joint;Hemoglobin level;Serum inflammatory markers;Imaging results; | — |
Countries
China
Contacts
Public ContactLihan Shi
Hospital of Chengdu University of Traditional Chinese Medicine
Outcome results
None listed