Rotator cuff injury
Conditions
Interventions
experimental group:absorbable suture anchor group
control group:BioComposite Suture Anchor
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years, no restriction on gender; 2. The blood coagulation function was normal, the heart, lung, liver and kidney functions were basically normal, and the operation could be tolerated; 3. The patients with rotator cuff injury have the indication of operation and can be repaired by rotator cuff injury according to the judgment of researchers; 4. Patients who received the first treatment with wire anchor or other similar products at the operation site; 5. Willing to sign informed consent, willing to cooperate with doctors to complete relevant treatment, examination and follow-up.
Exclusion criteria
Exclusion criteria: 1. Second revision operation was found in the treatment site. 2. According to the researchers' judgment, there are bone tissue lesions in the treatment site, such as serious osteoporosis, metabolic osteopathy, radiation osteopathy, bone tumor, rheumatoid arthritis, etc. 3. Patients whose soft tissues need to be fixed have pathological changes or poor quality judged by MRI, and can't pull the retracted tendon back to the original position of the stop even when the shoulder joint is abducted. 4. All kinds of conditions, such as blocked blood supply, previous infection and so on, that lead to or may lead to inadequate implant support or blocked rehabilitation. 5. For patients with multiple site or joint soft tissue injuries, other combined diseases limit their participation in the study, and patients who cannot follow up or affect the scientific and integrity of the study. 6. The patient is mentally incapacitated or unable to understand the requirements of participating in the study. 7. Patients are known to have a history of allergy to one or more implanted materials. 8. Subjects who have participated in clinical studies of other drugs, biological agents or medical devices before being selected and have not reached the main end-point time limit of the study. 9. Screening pregnancy or planned pregnancy during the trial. 10. Other situations that other researchers think should not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Shoulder MRI;Clinical efficiency; | — |
Secondary
| Measure | Time frame |
|---|---|
| ASES score;VAS;Shoulder mobility; | — |
Countries
China
Contacts
Public ContactJinzhong Zhao
Shanghai Sixth People's Hospital
Outcome results
None listed