Effect of PRP vs Corticosteroid in Rotator Cuff Tendinopathy Subtypes in Arthroscopic Repair (NCT05603468) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Effect of PRP vs Corticosteroid in Rotator Cuff Tendinopathy Subtypes in Arthroscopic Repair
China387 participantsStarted 2022-12-15
Plain-language summary
Prospective, multicenter, randomized, single-blinded, parallel group,placebo-controlled,three-group establishment of specific treatment regimen for subtypes of tendinopathy
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Rotator cuff tears were diagnosis by magnetic resonance imaging or arthroscopy
* Surgical intervention of rotator cuff tears was proposed.
* Simple full-layer tear of supraspinatus tendon.
* Patients give informed consent, and sign the informed consent form, and the process must meet the requirements of GCP
Exclusion Criteria:
* Patients with rotator cuff injuries involving infraspinatus, subscapularis, and teres minor tendon injuries
* Patients platelet concentration is lower than 100×109
* Patients have other shoulder diseases, including osteoarthritis, cervical spondylosis, etc.patients have inflammatory diseases, including rheumatoid arthritis, fibromyalgia, rheumatic polymyalgia, etc.patients have received injection treatment within 3 months.
* Patients have participated in clinical trials or are conducting other clinical trials within 3 months before screening.
* Patients have severe primary cardiovascular disease, lung disease, endocrine and metabolic disease or serious diseases that affect their survival, such as tumor or AIDS, the researchers believe that it is not suitable to be selected.
* Patients have severe liver, kidney and hematological lesions, such as kidney function exceeding the upper limit of normal value and liver function exceeding 2 times the upper limit of normal value.
* Patients have viral hepatitis, infectious diseases, severe abnormalities in blood coagulation and other diseases that the researchers consider unsuitable for…
What they're measuring
1
Oxford Shoulder Score (OSS)
Timeframe: 6months after surgery
Trial details
NCT IDNCT05603468
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University