Clinical trial NCT04121663: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shoulder Instability Rotator Cuff Injury
Keywords: Shoulder instability
Rotator cuff injury
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2019-10-10
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: UCLA score
timeFrame: 6 months
Secondary outcomes:
measure: UCLA score
timeFrame: 3 months
measure: constant-murley score
timeFrame: 3 months
measure: ASES score
timeFrame: 3 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Full seam anchor
state: Zhejiang
Study officials:
References: