Health Condition 1: S460- Injury of muscle(s) and tendon(s)of the rotator cuff of shoulder
Conditions
Interventions
Intervention1: Rotator cuff repair system: 6 week
3 month
6 month
12 month
Control Intervention1: None: N.A.
Sponsors
Auxein Medical Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Patients with confirmed Rotator cuff tear (MRI) and who are planned for Rotator Cuff repair through arthroscopy surgery.
Exclusion criteria
Exclusion criteria: 1. Patients with other shoulder injuries. 2. Patients with a disease or condition that could hinder healing and create an unacceptable risk of fixation failure or complications, such as known active cancer or neuromuscular disorders. 3. Patients with inadequate tissue coverage at the operative site. 4. Patients who are incarcerated or have pending incarceration. 5. Patient has a psychiatric illness, neurologic disorder, or cognitive deficit that would prevent compliance with study requirements. 6. Patient is unable to tolerate magnetic resonance imaging (MRI) due to psychiatric or medical contraindications. 7. Patient has any condition which, in the judgment of the Investigator, would place the patient at undue risk or interfere with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Improvement in patient reported outcomes ASES and WOSI. 2. Post-operative complications and AE/SAEs.Timepoint: 6 week 3 month 6 month 12 month | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient satisfaction 2. Percentage of patients returned to pre-injury level of activities.Timepoint: 6 week 3 month 6 month 12 month | — |
Countries
India
Contacts
Public ContactDr Mohd Aslam
Auxein Medical Pvt Ltd
Outcome results
None listed