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A study assessing success and failure after shoulder ligament surgery

A Single-center, Non-interventional, Observational study to assess Clinical Outcomes and Patient Reported Outcomes after treatment of Rotator Cuff Tears using Sironix Suture Anchor Devices

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/11/047427
Enrollment
40
Registered
2022-11-18
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

None listed

Sponsors

Healthium Medtech Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male/female patients aged >= 18 years and 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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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—

Countries

India

Contacts

Public ContactDr Ashok Kumar Moharana

Healthium Medtech Limited

ashok.m@healthiummedtech.com9717887751

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026