Clinical trial NCT05603468: Effect of PRP vs Corticosteroid in Rotator Cuff Tendinopathy Subtypes in Arthroscopic Repair
Official title: Effect of Platelet-Rich Plasma vs Corticosteroid Injection in Distinct Rotator Cuff Tendinopathy Subtypes in Arthroscopic Repair: a Multicenter, Three-group, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Tendinopathy
Keywords: Tendinopathy
Platelet Rich Plasma
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2022-11-02
Enrollment: 387
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective, multicenter, randomized, single-blinded, parallel group，placebo-controlled，three-group establishment of specific treatment regimen for subtypes of tendinopathy

Detailed description: This clinical trial uses machine learning to match molecular and clinical features，so as to establish a "rapid recognition system of tendinopathy subtypes" and compares the clinical effects of corticosteroid，platelet rich plasma or placebo on different subtypes of tendinopathy.

Eligibility criteria: 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 surgery.
* Women who are pregnant or lactating, or who plan to conceive during follow-up, those who are positive for human chorionic gonadotropin before sampling; menstrual women should wait for surgery after the end of menstruation.
* Patients have severe neurological and mental disorders.
* Patients suspect or do have a history of alcohol or drug abuse.
* Patients have height body mass index (BMI) \> 30.
* Patients have tendon disease caused by systemic immune or other diseases, and patients with diseases or symptoms that may affect pain or function scores.
* Patients have coagulation disorders caused by any other acute or chronic disease.
* MRI detection of contraindications. Include, but are not limited to: installation of pacemakers, defibrillators, cardiac stents, artificial heart valves, metal clips after aneurysm surgery, drug infusion devices implanted in the body, any electronic devices implanted in the body (nerve stimulators, bone growth stimulators), endovascular embolization steel rings, filters, ECG recording monitors, metal sutures, shrapnel or iron particles in the body, fixation of steel plates and nails after fracture surgery, Cochlear implant, middle ear graft, intraocular metal foreign body, etc. Claustrophobia, critically ill patients, etc.
* Refer to the April 2008 edition of the Law of the people's Republic of China on the Protection of disabled Persons, patients belong to the subjects of legal disabled persons
* Other situations in which the researchers judged that the subjects were not suitable to participate.

Primary outcomes:
measure: Oxford Shoulder Score (OSS)
timeFrame: 6months after surgery
Secondary outcomes:
measure: Oxford Shoulder Score (OSS)
timeFrame: 3 months, 1year, and 2years after surgery
measure: Constant-Mulery score(CMS)
timeFrame: 3 months, 6months, 1year, and 2years after surgery
measure: Fear-avoidance belief questionnaire(FABQ)
timeFrame: 3 months, 6months, 1year, and 2years after surgery
measure: Insomnia Severity Index(ISI)
timeFrame: 3 months, 6months, 1year, and 2years after surgery
measure: Hospital Anxiety and Depression Scale(HADS)
timeFrame: 3 months, 6months, 1year, and 2years after surgery
measure: SF-36
timeFrame: 3 months, 6months, 1year, and 2years after surgery
measure: Visual analogue scale(VAS)
timeFrame: 3 months, 6months, 1year, and 2years after surgery
measure: range of motion
timeFrame: 3 months, 6months, 1year, and 2years after surgery
measure: muscle strength
timeFrame: 3 months, 6months, 1year, and 2years after surgery
measure: retear rate
timeFrame: 3 months, 6months, 1year, and 2years after surgery
measure: Acromiohumeral distance
timeFrame: 3 months, 6months, 1year, and 2years after surgery
measure: Signal to noise ratio of tendon in MRI
timeFrame: 3 months, 6months, 1year, and 2years after surgery
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References: