| CTRI Number |
CTRI/2022/11/047637 [Registered on: 24/11/2022] Trial Registered Prospectively |
| Last Modified On: |
19/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective Observational |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess success and failure after knee ligament surgery |
|
Scientific Title of Study
|
A retrospective, single centre, observational study to evaluate the safety, clinical outcomes and patient reported outcomes after meniscus repair using Surestitch all inside meniscal repair implant. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SIRONIX-010-22 Version No: 1.0 Date: 25 October 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 Mukesh Garg |
Sarvodaya Hospital and Research Centre |
Ground Floor, Orthopedic OPD, Sector-8, YMCA Rd, near Escorts Mujesar Metro Station, Sector 7
Faridabad
HARYANA |
9540583068
mukesh_imsbhu@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SARVODAYA HOSPITAL & RESEARCH CENTRE – INSTITUTIONAL 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. Male or Female patients with age of 18-80.
2. Patients who underwent meniscus repair with Surestitch meniscus repair implant between October 2020 to July 2022.
3. Able to give written informed consent during hospital visit or provide a verbal consent during a telephonic visit.
|
|
| ExclusionCriteria |
| Details |
1. Patient who has suffered from traumatic injury to the operated knee after the meniscus repair surgery
2. Patient who cannot be contacted for attending an inclinic/telephonic follow-up visit.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the clinical outcomes after meniscus repair using Surestitch all inside meniscal repair implant. |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the patient reported outcomes after meniscus repair using Surestitch all inside meniscal repair implant
2. To evaluate the safety of the SURESTITCHâ„¢ meniscal repair implant after meniscus repair surgery.
|
At baseline |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/11/2022 |
| 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
|
This
study is a retrospective, single centre, observational study to evaluate the
safety, clinical outcomes and patient reported outcomes after meniscus repair
using Surestitch all inside meniscal repair implant. All patients who had
undergone meniscus repair using Surestitch all inside meniscal repair implant
between October 2020 to July 2022 will be included in the study. |