Status:
UNKNOWN
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
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Shoulder Instability Rotator Cuff Injury
Eligibility:
All Genders
18-75 years
Phase:
NA
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. an...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2020
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04121663
Start Date
September 22 2019
End Date
October 31 2020
Last Update
October 10 2019
Active Locations (1)
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1
Full seam anchor
Hangzhou, Zhejiang, China, 310000