FindTrial
Sign In

A study to assess result after shoulder surgery

A Single-center, Non – interventional, Observational, Post market clinical follow-up study to assess Clinical Outcomes and Patient Reported Outcomes after treatment of shoulder injuries using Sironix Suture Anchor Devices - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/07/055329
Enrollment
50
Registered
2023-07-18
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

Health Condition 1: M999- Biomechanical lesion, unspecified

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Healthium Medtech Limited
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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—

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