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
- Conditions
- Shoulder Instability Rotator Cuff Injury
- Interventions
- Device: Total arthroscopic rotator cuff repair
- Registration Number
- NCT04121663
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 36
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Full seam anchor Total arthroscopic rotator cuff repair - Polyether ether ketone bone anchor Total arthroscopic rotator cuff repair -
- Primary Outcome Measures
Name Time Method UCLA score 6 months Efficiency of 6 months after operation=Number of subjects with excellent score + good + acceptable score / total number of subjects \* 100%
- Secondary Outcome Measures
Name Time Method UCLA score 3 months Efficiency of 3 months after operation=Number of subjects with excellent score + good + acceptable score / total number of subjects \* 100%
constant-murley score 3 months The higher the score, the better shoulder function.
ASES score 3 months The higher the score, the better shoulder function.
Trial Locations
- Locations (1)
Full seam anchor
🇨🇳Hangzhou, Zhejiang, China