A study to assess result after shoulder surgery
Not Applicable
Completed
- Conditions
- Health Condition 1: M999- Biomechanical lesion, unspecified
- Registration Number
- CTRI/2023/07/055329
- Lead Sponsor
- Healthium Medtech Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
1)Male/female patients aged = 18 years and = 80 years at the time of surgery
2)Patients who had undergone treatment for either rotator cuff tear repair or bankart repair with Sironix suture anchor devices with a minimum of 4 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 have had any traumatic injury to the operated shoulder post surgery.
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 1)To assess the clinical outcomes in the patients who underwent treatment for shoulder injuries using Sironix suture anchorsTimepoint: One follow up after EC approval, 4 months to 2.5 years after surgery
- Secondary Outcome Measures
Name Time Method To evaluate the patient reported outcomes, safety of the Sironix suture anchors in the patients who underwent treatment for shoulder injuriesTimepoint: One follow up after EC approval, 4 months to 2.5 years after surgery