A study assessing success and failure after shoulder ligament surgery
Not Applicable
Completed
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2022/11/047427
- Lead Sponsor
- Healthium Medtech Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 54
Inclusion Criteria
1. Male/female patients aged >= 18 years and <= 80 years at the time of surgery.
2. Patients who had undergone surgery with Sironix Suture Anchor Devices with a minimum of 6 months of follow-up.
3. Patients who are willing to provide written informed consent (in case of a physical visit to the site) or verbal informed consent (in case of a telephonic visit).
Exclusion Criteria
1. Patients who are diagnosed with other serious shoulder injury that can cause shoulder pain (tumor of shoulder, acute fracture, and dislocation of shoulder).
2. Patients who are not willing to attend the follow-up.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the clinical outcomes in the patients who underwent treatment for rotator cuff tears using Sironix suture anchors.Timepoint: One followup after EC approval 6 months to 4 years after surgery
- Secondary Outcome Measures
Name Time Method To evaluate the patient-reported outcomes and safety of the Sironix suture anchors in the patients who underwent treatment for rotator cuff tearsTimepoint: One followup after EC approval 6 months to 4 years after surgery