Shoulder Instability Rotator Cuff Injury
Conditions
Keywords
Shoulder instability, Rotator cuff injury
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
Interventions
DEVICETotal arthroscopic rotator cuff repair
The equivalence of the two devices was compared by using control and experimental instruments during the operation
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed