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

NCT ID: NCT04121663

Last Updated: 2019-10-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-22
• Study Completion Date: 2020-10-31

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

Conditions

Shoulder Instability Rotator Cuff Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Full seam anchor

Group Type: EXPERIMENTAL

Total arthroscopic rotator cuff repair

Intervention Type: DEVICE

The equivalence of the two devices was compared by using control and experimental instruments during the operation

Polyether ether ketone bone anchor

Group Type: ACTIVE_COMPARATOR

Total arthroscopic rotator cuff repair

Intervention Type: DEVICE

The equivalence of the two devices was compared by using control and experimental instruments during the operation

Interventions

Total arthroscopic rotator cuff repair

The equivalence of the two devices was compared by using control and experimental instruments during the operation

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Full seam anchor

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

2018-159

Identifier Type: -

Identifier Source: org_study_id