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Non-inferiority Evaluation of Multicenter, Randomized, Single-blind, Parallel-controlled Clinical Trials on the Safety and Efficacy of Full-suture Anchors for Rotator Cuff Injury and/or Shoulder Instability Surgery (MST-002)

Primary Purpose

Shoulder Instability Rotator Cuff Injury

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Total arthroscopic rotator cuff repair
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 Shoulder Instability Rotator Cuff Injury focused on measuring Shoulder instability, Rotator cuff injury

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. The age of the patients ranged from 18 to 75 years (including 18 and 75 years), with no gender limitation
  2. Patients with rotator cuff injury and/or instability of the shoulder joint are eligible for surgical indications of suture anchor
  3. Subjects were willing and able to sign informed consent

Exclusion Criteria:

  1. Patients with severe osteoporosis；
  2. A variety of conditions, such as previous infection, suspected infection, current infection, that may or may lead to insufficient implant support or impaired rehabilitation；
  3. Those with severe allergic constitution (e.g. severe allergic purpura, asthma, rhinitis, shock, etc.)；
  4. Patients with abnormal liver and kidney function [SGPT (ALT) or SGOT (AST) or creatinine (CR)] were 1.5 times higher than the upper limit of normal value; patients with coagulation dysfunction (such as prothrombin time (PT) prolonged or shortened > 3 s, activated partial thromboplastin time (aPTT) prolonged or shortened > 10 s, platelet count (PLT) < 50 *109/L)；
  5. Those with severe cardiopulmonary disease and uncontrolled epilepsy within half a year are limited to participate in the study；
  6. Cervical spinal cord disease, brachial plexus nerve injury, poor compliance, psychosis, mental disorders, difficult to cooperate with；
  7. Pregnancy test positive, pregnant or lactating women, recent family planning; during the trial can not take feasible contraceptive measure；
  8. Surgical site peripheral nerve injury；
  9. Subjects who had participated in clinical studies of other drugs, biological agents or medical devices before enrollment did not reach the primary endpoint
  10. High blood pressure control is still not suitable for surgery；
  11. Malignant Tumor Patients；
  12. Researchers believe that there are other circumstances that are not suitable for this clinical trial.

Sites / Locations

  • Full seam anchor

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Full seam anchor

Polyether ether ketone bone anchor

Arm Description

Outcomes

Primary Outcome Measures

UCLA score
Efficiency of 6 months after operation=Number of subjects with excellent score + good + acceptable score / total number of subjects * 100%

Secondary Outcome Measures

UCLA score
Efficiency of 3 months after operation=Number of subjects with excellent score + good + acceptable score / total number of subjects * 100%
constant-murley score
The higher the score, the better shoulder function.
ASES score
The higher the score, the better shoulder function.

Full Information

First Posted
September 25, 2019
Last Updated
October 8, 2019
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT04121663
Brief Title
Non-inferiority Evaluation of Multicenter, Randomized, Single-blind, Parallel-controlled Clinical Trials on the Safety and Efficacy of Full-suture Anchors for Rotator Cuff Injury and/or Shoulder Instability Surgery
Acronym
MST-002
Official Title
Non-inferiority Evaluation of Multicenter, Randomized, Single-blind, Parallel-controlled Clinical Trials on the Safety and Efficacy of Full-suture Anchors for Rotator Cuff Injury and/or Shoulder Instability Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 22, 2019 (Actual)
Primary Completion Date
April 30, 2020 (Anticipated)
Study Completion Date
October 31, 2020 (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
Multicenter, randomized, single-blind, parallel-controlled non-inferiority assessment for safety and efficacy of rotator cuff injury and/or shoulder instability surgery
Detailed Description
This clinical trial compares the clinical effects of rotator cuff injury and/or shoulder instability surgery with the full suture anchor made by Hangzhou Ruijian Mastine Medical Equipment Co., Ltd. and the polyether ether ketone bone anchor system made by Arthrex, Inc., USA, and evaluates the safety and effectiveness of the experimental device in clinical application

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Instability Rotator Cuff Injury
Keywords
Shoulder instability, Rotator cuff injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Full seam anchor
Arm Type
Experimental
Arm Title
Polyether ether ketone bone anchor
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Total arthroscopic rotator cuff repair
Intervention Description
The equivalence of the two devices was compared by using control and experimental instruments during the operation
Primary Outcome Measure Information:
Title
UCLA score
Description
Efficiency of 6 months after operation=Number of subjects with excellent score + good + acceptable score / total number of subjects * 100%
Time Frame
6 months
Secondary Outcome Measure Information:
Title
UCLA score
Description
Efficiency of 3 months after operation=Number of subjects with excellent score + good + acceptable score / total number of subjects * 100%
Time Frame
3 months
Title
constant-murley score
Description
The higher the score, the better shoulder function.
Time Frame
3 months
Title
ASES score
Description
The higher the score, the better shoulder function.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The age of the patients ranged from 18 to 75 years (including 18 and 75 years), with no gender limitation Patients with rotator cuff injury and/or instability of the shoulder joint are eligible for surgical indications of suture anchor Subjects were willing and able to sign informed consent Exclusion Criteria: Patients with severe osteoporosis； A variety of conditions, such as previous infection, suspected infection, current infection, that may or may lead to insufficient implant support or impaired rehabilitation； Those with severe allergic constitution (e.g. severe allergic purpura, asthma, rhinitis, shock, etc.)； Patients with abnormal liver and kidney function [SGPT (ALT) or SGOT (AST) or creatinine (CR)] were 1.5 times higher than the upper limit of normal value; patients with coagulation dysfunction (such as prothrombin time (PT) prolonged or shortened > 3 s, activated partial thromboplastin time (aPTT) prolonged or shortened > 10 s, platelet count (PLT) < 50 *109/L)； Those with severe cardiopulmonary disease and uncontrolled epilepsy within half a year are limited to participate in the study； Cervical spinal cord disease, brachial plexus nerve injury, poor compliance, psychosis, mental disorders, difficult to cooperate with； Pregnancy test positive, pregnant or lactating women, recent family planning; during the trial can not take feasible contraceptive measure； Surgical site peripheral nerve injury； Subjects who had participated in clinical studies of other drugs, biological agents or medical devices before enrollment did not reach the primary endpoint High blood pressure control is still not suitable for surgery； Malignant Tumor Patients； Researchers believe that there are other circumstances that are not suitable for this clinical trial.
Facility Information:
Facility Name
Full seam anchor
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China

12. IPD Sharing Statement

Learn more about this trial

Non-inferiority Evaluation of Multicenter, Randomized, Single-blind, Parallel-controlled Clinical Trials on the Safety and Efficacy of Full-suture Anchors for Rotator Cuff Injury and/or Shoulder Instability Surgery

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