Observational Study
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Orthop. Dec 18, 2024; 15(12): 1183-1190
Published online Dec 18, 2024. doi: 10.5312/wjo.v15.i12.1183
Assessing clinical and patient reported outcomes of Sironix suture anchors in rotator cuff and Bankart repair surgeries
Puthumanapully Vinod Kumar, Subin Sugath, Vijay Mohan, Ashok Kumar Moharana, Sachin Angrish, Deepak TS
Puthumanapully Vinod Kumar, Vijay Mohan, Department of Orthopedics, Aster Medcity, Kochi 682027, Kerala, India
Subin Sugath, Department of Orthopedic Oncology, Aster Medcity, Kochi 682027, Kerala, India
Ashok Kumar Moharana, Sachin Angrish, Deepak TS, Department of Clinical Affairs, Healthium Medtech Limited, Bangalore 560058, Karnātaka, India
Author contributions: Kumar PV, Sugath S, Mohan V, Moharana AK, Angrish S, and TS D contributed to the conception and design of the study, preparation of the materials, collection and analysis of the data, and review and approval of the final manuscript.
Institutional review board statement: This study was approved by Institutional Research and Ethics Committee Aster Medcity, Kochi on 23rd June 2023 with approval identifier AM/EC/325-3023.
Informed consent statement: Informed consent was obtained from all patients prior to participation.
Conflict-of-interest statement: Moharana AK, Angrish S, and TS D are employees of Healthium Medtech Limited, India, who are manufacturers of Sironix shoulder implants. Kumar V, Sugath S, and Mohan V declare no conflicts of interest.
Data sharing statement: Statistical code and dataset available from the corresponding author at deepak.ts@healthiummedtech.com. Participants gave informed consent for presenting anonymized data.
STROBE statement: The authors have read the STROBE Statement—checklist of items, and the manuscript was prepared and revised according to the STROBE Statement—checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Deepak TS, MD, Doctor, Department of Clinical Affairs, Healthium Medtech Limited, 472D, 13th Cross, 4th Phase, Peenya Industrial Area, Bangalore 560058, Karnātaka, India. deepak.ts@healthiummedtech.com
Received: July 17, 2024
Revised: November 5, 2024
Accepted: December 5, 2024
Published online: December 18, 2024
Processing time: 152 Days and 22.1 Hours
Abstract
BACKGROUND

Rotator cuff tears and Bankart lesions significantly affect shoulder function and quality of life. Arthroscopic rotator cuff repair and Bankart repair has become the standard treatment for restoring function and reducing pain. Recent advancements include new suture anchor technologies, such as the Sironix suture anchor known for its biomechanical strength and promising outcomes. However, there are limited real-world data on its effectiveness and safety, particularly in the Indian population.

AIM

To evaluate the effectiveness and safety of Sironix suture anchors in rotator cuff and Bankart repair surgeries.

METHODS

Sixty participants underwent surgery between January 2021 and December 2022, and demographic data and postoperative outcomes were collected through retrospective reviews and telephonic interviews. Validated scales, including the PENN Shoulder Score (PSS), Disabilities of the Arm, Shoulder, and Hand (DASH) score, and Single Assessment Numeric Evaluation (SANE), were utilized for assessment.

RESULTS

Treatment with Sironix suture anchor devices, including Ceptre Knotted UHMWPE Suture Titanium Anchor, Spyke Knotted UHMWPE Suture Peek Anchor, Stativ Knotted UHMWPE Suture Anchor, and Viplok Knotless Peek Screw Anchor with Titanium Tip, revealed no repair failures. Participants demonstrated high satisfaction and functional improvement, as evidenced by the mean Quick DASH score (32.01) and PSS (71.65) and the satisfactory SANE scores for both injured joints (74.33) and non-injured (83.67) shoulder joints.

CONCLUSION

The study yielded favorable outcomes for rotator cuff tear repair and Bankart repair. No repair failures were observed, supporting the safety and efficacy of these devices in shoulder injury management.

Keywords: Arthroscopic Bankart repair; Rotator cuff repair; Shoulder injuries; Suture anchor; Treatment outcome

Core Tip: This study assessed clinical outcomes and patient-reported outcomes after treating shoulder injuries using Sironix suture anchor devices. Treatment with Sironix suture anchor devices yielded favorable outcomes for rotator cuff tear repair and Bankart repair in terms of safety and efficacy.