| CTRI Number |
CTRI/2023/07/055329 [Registered on: 18/07/2023] Trial Registered Prospectively |
| Last Modified On: |
13/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess result after shoulder surgery |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HML-RCB-001-23, Version 01, Date 02/05/2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashok Kumar Moharana |
| Designation |
Chief Medical Officer |
| Affiliation |
Healthium Medtech Limited |
| Address |
472D, 13th Cross, 4th Phase, Peenya Industrial Area Phase IV, Peenya
Bangalore
KARNATAKA
560058
India |
| Phone |
9717887751 |
| Fax |
|
| Email |
ashok.m@healthiummedtech.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Kumar Moharana |
| Designation |
Chief Medical Officer |
| Affiliation |
Healthium Medtech Limited |
| Address |
472D, 13th Cross, 4th Phase, Peenya Industrial Area Phase IV, Peenya
Bangalore
KARNATAKA
560058
India |
| Phone |
9717887751 |
| Fax |
|
| Email |
ashok.m@healthiummedtech.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Kumar Moharana |
| Designation |
Chief Medical Officer |
| Affiliation |
Healthium Medtech Limited |
| Address |
472D, 13th Cross, 4th Phase, Peenya Industrial Area Phase IV, Peenya
Bangalore
KARNATAKA
560058
India |
| Phone |
9717887751 |
| Fax |
|
| Email |
ashok.m@healthiummedtech.com |
|
|
Source of Monetary or Material Support
|
| Healthium Medtech Limited, 472D, 13th cross, 4th phase, Peenya Industrial Area, Bangalore KARNATAKA 560058 India |
|
|
Primary Sponsor
|
| Name |
Healthium Medtech Limited |
| Address |
472/D, 13th Cross, 4th Phase, Peenya Industrial Area Phase IV, Peenya, Bengaluru, Karnataka - 560 058, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vinod Kumar P |
Aster Medcity |
Room no 1, Orthopedics OPD, Kuttisahib Road Cheranelloor, South Chittoor, Kochi, Kerala 682027
Ernakulam
KERALA |
9744961177
ORTHO-SURGEON@GMX.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research and Ethics Committee Aster Medcity, Kochi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M999||Biomechanical lesion, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
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) |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1)To assess the clinical outcomes in the patients who underwent treatment for shoulder injuries using Sironix suture anchors |
One follow up after EC approval, 4 months to 2.5 years after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the patient reported outcomes, safety of the Sironix suture anchors in the patients who underwent treatment for shoulder injuries |
One follow up after EC approval, 4 months to 2.5 years after surgery |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/07/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a single center, retrospective, 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. All patients who underwent treatment for shoulder injuries that includes rotator cuff tear repair or bankart repair surgery between January 2021 to December 2022 will be included in the study. Our study is aimed at investigating the efficacy and safety of the interventions used in the treatment of shoulder injuries. |