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

Primary Purpose

Tendinopathy

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
platelet rich plasma
Corticosteroid
Normal saline
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tendinopathy focused on measuring Tendinopathy, Platelet Rich Plasma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • 2nd Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Platelet Rich Plasma group

Corticosteroid group

Normal saline group

Arm Description

patients rejected with platelet rich plasma

patients rejected with corticosteroid

patients rejected with normal saline

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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.
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.
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.
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"
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.
range of motion
Measure the patient's flexion, abduction, internal rotation and external rotation angle
muscle strength
Use dynamometer to evaluate patient's forward bending, abduction, external rotation and internal rotation strength.
retear rate
Proportion of the total number of people with retearing after arthroscopic rotator cuff repair
Acromiohumeral distance
Measurement of acromiohumeral distance based on x-ray
Signal to noise ratio of tendon in MRI
Measurement of Signal to Noise Ratio of Tendon in MRI based on software

Full Information

First Posted
October 25, 2022
Last Updated
February 15, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05603468
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 24, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendinopathy
Keywords
Tendinopathy, Platelet Rich Plasma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
387 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Platelet Rich Plasma group
Arm Type
Experimental
Arm Description
patients rejected with platelet rich plasma
Arm Title
Corticosteroid group
Arm Type
Active Comparator
Arm Description
patients rejected with corticosteroid
Arm Title
Normal saline group
Arm Type
Placebo Comparator
Arm Description
patients rejected with normal saline
Intervention Type
Drug
Intervention Name(s)
platelet rich plasma
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Corticosteroid
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Normal saline
Primary Outcome Measure Information:
Title
Oxford Shoulder Score (OSS)
Description
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.
Time Frame
6months after surgery
Secondary Outcome Measure Information:
Title
Oxford Shoulder Score (OSS)
Description
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
Time Frame
3 months, 1year, and 2years after surgery
Title
Constant-Mulery score(CMS)
Description
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.
Time Frame
3 months, 6months, 1year, and 2years after surgery
Title
Fear-avoidance belief questionnaire(FABQ)
Description
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.
Time Frame
3 months, 6months, 1year, and 2years after surgery
Title
Insomnia Severity Index(ISI)
Description
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.
Time Frame
3 months, 6months, 1year, and 2years after surgery
Title
Hospital Anxiety and Depression Scale(HADS)
Description
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.
Time Frame
3 months, 6months, 1year, and 2years after surgery
Title
SF-36
Description
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"
Time Frame
3 months, 6months, 1year, and 2years after surgery
Title
Visual analogue scale(VAS)
Description
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.
Time Frame
3 months, 6months, 1year, and 2years after surgery
Title
range of motion
Description
Measure the patient's flexion, abduction, internal rotation and external rotation angle
Time Frame
3 months, 6months, 1year, and 2years after surgery
Title
muscle strength
Description
Use dynamometer to evaluate patient's forward bending, abduction, external rotation and internal rotation strength.
Time Frame
3 months, 6months, 1year, and 2years after surgery
Title
retear rate
Description
Proportion of the total number of people with retearing after arthroscopic rotator cuff repair
Time Frame
3 months, 6months, 1year, and 2years after surgery
Title
Acromiohumeral distance
Description
Measurement of acromiohumeral distance based on x-ray
Time Frame
3 months, 6months, 1year, and 2years after surgery
Title
Signal to noise ratio of tendon in MRI
Description
Measurement of Signal to Noise Ratio of Tendon in MRI based on software
Time Frame
3 months, 6months, 1year, and 2years after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
weiliang shen, doctor
Phone
86-0571-86995513
Email
wlshen@zju.edu.cn
Facility Information:
Facility Name
2nd Affiliated Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310058
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
weiliang shen, Doctor
Phone
86-0571-86995513
Email
wlshen@zju.edu.cn

12. IPD Sharing Statement

Learn more about this trial

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

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