| CTRI Number |
CTRI/2022/10/046852 [Registered on: 27/10/2022] Trial Registered Prospectively |
| Last Modified On: |
19/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess the effect after video assisted shoulder ligament surgery |
|
Scientific Title of Study
|
Assessment of Safety, Efficacy, and Functional Outcomes after Rotator Cuff Repair using Ceptre® Titanium Screw Anchor: A Single Centre, Retrospective, Observational Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SIRONIX-012-22; Version no. 1; Date 29 September 2022 |
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
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
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 Phase IV, Peenya, KARNATAKA 560058, India |
|
|
Primary Sponsor
|
| Name |
Healthium Medtech Limited |
| Address |
472D, 13th Cross, 4th Phase, Peenya Industrial Area Phase IV, Peenya, KARNATAKA 560058, 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 Karnav Arvind Panchal |
EPIC Hospital |
Ground floor, Department of Orthopedics, Empire Doctor House, Opp Kargil Petrol Pump S G Highway,
Ahmadabad
GUJARAT |
9879010009
karnav1985@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| EPIC Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged ≥18 years who has undergone rotator cuff repair surgery with Ceptre® Titanium Screw Anchor between January 2019 to July 2022.
2. Patients willing to give written consent for the study during an in-clinic visit or providing verbal consent for participation during a telephonic visit
|
|
| ExclusionCriteria |
| Details |
1. Patients who suffered from traumatic injury to the operated shoulder after surgery.
2. Patients who cannot be contacted after three attempts |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the functional outcomes after Rotator Cuff Repair with Ceptre® Titanium Screw Anchor |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To review the safety of Ceptre® Titanium Screw Anchor by evaluating adverse events after surgery.
2. To review the efficacy of Ceptre® Titanium Screw Anchor after Rotator Cuff Repair. |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "39"
Final Enrollment numbers achieved (India)="39" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/10/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The current retrospective study is aimed to assess the safety, efficacy, and functional outcomes of Sironix arthroscopic implants in patients who have undergone Rotator Cuff Tear (RCT) repair. |