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)

Multicenter, randomized, single-blind, parallel-controlled non-inferiority assessment for safety and efficacy of rotator cuff injury and/or shoulder instability surgery

Study Overview

• Status: Unknown
• Conditions: Shoulder Instability Rotator Cuff Injury
• Intervention / Treatment: Device: Total arthroscopic rotator cuff repair

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

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Full seam anchor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Full seam anchor	Device: Total arthroscopic rotator cuff repair; The equivalence of the two devices was compared by using control and experimental instruments during the operation
Active Comparator: Polyether ether ketone bone anchor	Device: Total arthroscopic rotator cuff repair; The equivalence of the two devices was compared by using control and experimental instruments during the operation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2019
• Primary Completion (Anticipated): April 30, 2020
• Study Completion (Anticipated): October 31, 2020

Study Registration Dates

• First Submitted: September 25, 2019
• First Submitted That Met QC Criteria: October 8, 2019
• First Posted (Actual): October 10, 2019

Study Record Updates

• Last Update Posted (Actual): October 10, 2019
• Last Update Submitted That Met QC Criteria: October 8, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Rotator cuff injury; Shoulder instability
• Additional Relevant MeSH Terms: Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries; Wounds and Injuries
• Other Study ID Numbers: 2018-159

Drug and device information, study documents

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