Effect of PRP vs Corticosteroid in Rotator Cuff Tendinopathy Subtypes in Arthroscopic Repair

NCT05603468 | Active Not Recruiting Phase 4

• 1 other identifier: 2022-0833
• Study Type: interventional
• Target: 387
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tendinopathy

Keywords

Tendinopathy; Platelet Rich Plasma

Outcome Measures

Primary Outcomes (1)

• Oxford Shoulder Score (OSS)

  The Oxford Shoulder Score (OSS) consists of 12 questions with five options each. The light to heavy lines were assigned 1, 2, 3, 4 and 5 points respectively. So the total score is between 12 and 60. A score of 12 represents perfectly normal shoulder function and a score of 60 represents the most severe difficulty in shoulder function.

  6months after surgery

Secondary Outcomes (12)

• Oxford Shoulder Score (OSS)

  3 months, 1year, and 2years after surgery

• Constant-Mulery score(CMS)

  3 months, 6months, 1year, and 2years after surgery

• Fear-avoidance belief questionnaire(FABQ)

  3 months, 6months, 1year, and 2years after surgery

• Insomnia Severity Index(ISI)

  3 months, 6months, 1year, and 2years after surgery

• Hospital Anxiety and Depression Scale(HADS)

  3 months, 6months, 1year, and 2years after surgery

Study Arms (3)

Platelet Rich Plasma group

EXPERIMENTAL

patients rejected with platelet rich plasma

Drug: platelet rich plasma

Corticosteroid group

ACTIVE COMPARATOR

patients rejected with corticosteroid

Drug: Corticosteroid

Normal saline group

PLACEBO COMPARATOR

patients rejected with normal saline

Drug: Normal saline

Interventions

platelet rich plasma DRUG

Platelet rich plasma group: after the surgery of rotator arthroscopic rotator cuff repair, 3ml PRP (LongTai Biological Company) was injected into the rotator cuff tear under the rotator arthroscope for a time. PRP production process: before anesthesia, 20ml arterial blood was drawn and injected into the PRP tube. The blood was fully oscillated in the tube, and then placed in a centrifuge with 1500g for 9min to remove excess plasma and make 5ml PRP. 3ml is used for injection and 2ml is used for quality control.

Platelet Rich Plasma group

Corticosteroid DRUG

Corticosteroid group: after the surgery of rotator cuff repair under arthroscopy, 1mL prednisone (MSD) + 2mL sodium hyaluronate (biochemical Industry Co., Ltd.) was injected under arthroscopy.

Corticosteroid group

Normal saline DRUG

Normal saline

Normal saline group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310058, China

Location

MeSH Terms

Conditions

Tendinopathy

Interventions

Adrenal Cortex Hormones; Saline Solution

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: November 2, 2022
• Study Start: December 15, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 9, 2026

Record last verified: 2026-01

Locations

CN (1)