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A study to assess success after shoulder ligament repair surgery

A Retrospective, Observational, Study to Evaluate the Functional Outcomes in Patients Who Underwent Arthroscopic Rotator Cuff Tears Repair Using Sironix Suture Anchor

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/12/048062
Enrollment
40
Registered
2022-12-13
Start date
Unknown
Completion date
Unknown
Last updated
2023-02-06

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 of 18 to 80 years of age. 2. Patients who underwent arthroscopic rotator cuff tears repair using Sironix suture anchor between the period of January 2019 to June 2022. 3. Patient willing to give written informed consent to participate in the study when attending an in-clinic follow-up visit, or providing verbal consent during the telephonic follow-up visit.

Exclusion criteria

Exclusion criteria: 1. Patients not responding to calls after three attempts or not interested to participate in the study. 2. Patients with traumatic injury to the same shoulder post rotator cuff tears repair procedure.

Design outcomes

Primary

MeasureTime frame
To evaluate the function of the shoulder after Arthroscopic Rotator Cuff Tears RepairTimepoint: One followup after EC approval 3 months to 3.5 years after surgery

Secondary

MeasureTime frame
1. To assess the level of activity pre and post-surgery 2. To assess quality of life after Rotator Cuff Tears Repair 3. To assess the adverse events associated with Arthroscopic Rotator Cuff Tears Repair Timepoint: One followup after EC approval 3 months to 3.5 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