A study to assess success after shoulder ligament tear repair surgery

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2022/10/046794

Enrollment

Registered

2022-10-26

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

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

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male/ Female Patients of 18 to 80 years of age 2. Patients who underwent arthroscopic rotator cuff tears restoration 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 restoration procedure

Design outcomes

Primary

Measure	Time frame
To evaluate the function of the shoulder after Arthroscopic Rotator Cuff Tears RestorationTimepoint: One followup after EC approval 3 months to 3.5 years after surgery	—

Secondary

Measure	Time frame
1. To assess the level of activity pre and post-surgery 2. To assess quality of life after Rotator Cuff Tears Restoration 3. To assess the adverse events associated with Arthroscopic Rotator Cuff Tears Restoration 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