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

Effect of Platelet-Rich Plasma vs Corticosteroid Injection in Distinct Rotator Cuff Tendinopathy Subtypes in Arthroscopic Repair: a Multicenter, Three-group, Randomized Controlled Trial

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

Study Overview

• Status: Recruiting
• Conditions: Tendinopathy
• Intervention / Treatment: Drug: Normal saline; Drug: platelet rich plasma; Drug: Corticosteroid

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.

• Study Type: Interventional
• Enrollment (Anticipated): 387
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: weiliang shen, Doctor; Phone Number: 86-0571-86995513; Email: wlshen@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310058
      • Recruiting
      • 2nd Affiliated Hospital, School of Medicine, Zhejiang University
      • Contact: weiliang shen, Doctor; Phone Number: 86-0571-86995513; Email: wlshen@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Platelet Rich Plasma group; patients rejected with platelet rich plasma	Drug: platelet rich plasma; 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.
Active Comparator: Corticosteroid group; patients rejected with corticosteroid	Drug: Corticosteroid; 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.
Placebo Comparator: Normal saline group; patients rejected with normal saline	Drug: Normal saline; Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months, 1year, and 2years after surgery
Constant-Mulery score(CMS)	The Constant-Mulery score mainly includes 8 aspects related to your shoulder in the past 4 weeks. The proportion of subjective and objective components in the Constant-Mulery score is 35 points/65 points. A total of 100 points.The subjective part of the score includes the score of pain degree and the score of impact on daily life. 35 points in total.The objective part of the score includes the score of shoulder range of motion and strength. 65 points in total.	3 months, 6months, 1year, and 2years after surgery
Fear-avoidance belief questionnaire(FABQ)	The FABQ is a self-assessment scale with 16 options. Each option has 0~6 points and 7 grades (from extremely disagreeable to extremely agreed). "0" means completely disagreed, "6" means completely agreed, and "1~5" means not sure. The higher the score, the more inclined to fully agree.	3 months, 6months, 1year, and 2years after surgery
Insomnia Severity Index(ISI)	The scale is a simple tool for screening insomnia, including 7 items, which are used to evaluate the nature and symptoms of sleep disorders of subjects.	3 months, 6months, 1year, and 2years after surgery
Hospital Anxiety and Depression Scale(HADS)	HADS is a self-assessment scale, including two subscales, HADS-A and HADS-D, with a total of 14 items, including 7 items for anxiety (A) and 7 items for depression (D). Each item is scored at four levels according to the frequency of symptoms in the past month. Each item is scored at 0-3 points in four levels. The higher the score, the more serious the anxiety or depression.	3 months, 6months, 1year, and 2years after surgery
SF-36	SF-36 is a concise health questionnaire developed by the Boston Institute of Health, which is widely used in the measurement of the quality of life of the general population, the evaluation of clinical trials and the evaluation of health policies. SF-36 is used to assess physiological function, physiological function, physical pain, general health, energy, social function, emotional function and mental health, which are classified into "physical health" and "mental health"	3 months, 6months, 1year, and 2years after surgery
Visual analogue scale(VAS)	Draw a 10cm horizontal line on the paper. One end of the line is "0", indicating no pain; the other end is "10", indicating severe pain; The middle represents different degrees of pain; Let the patient draw a mark on the horizontal line according to their feelings to indicate the degree of pain.	3 months, 6months, 1year, and 2years after surgery
range of motion	Measure the patient's flexion, abduction, internal rotation and external rotation angle	3 months, 6months, 1year, and 2years after surgery
muscle strength	Use dynamometer to evaluate patient's forward bending, abduction, external rotation and internal rotation strength.	3 months, 6months, 1year, and 2years after surgery
retear rate	Proportion of the total number of people with retearing after arthroscopic rotator cuff repair	3 months, 6months, 1year, and 2years after surgery
Acromiohumeral distance	Measurement of acromiohumeral distance based on x-ray	3 months, 6months, 1year, and 2years after surgery
Signal to noise ratio of tendon in MRI	Measurement of Signal to Noise Ratio of Tendon in MRI based on software	3 months, 6months, 1year, and 2years after surgery

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2022
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: October 25, 2022
• First Submitted That Met QC Criteria: October 28, 2022
• First Posted (Actual): November 2, 2022

Study Record Updates

• Last Update Posted (Estimate): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Platelet Rich Plasma; Tendinopathy
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: 2022-0833

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No