| CTRI Number |
CTRI/2023/05/052392 [Registered on: 09/05/2023] Trial Registered Prospectively |
| Last Modified On: |
19/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess outcomes after knee ligament surgery |
|
Scientific Title of Study
|
A Retrospective, Observational, Post-Marketing Study to Evaluate the Functional Outcomes in Patients Who Underwent Arthroscopic Anterior Cruciate Ligament (ACL) Reconstruction Using Sironix Suture Button and Peek Button. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SIRONIX-021-23 Version No: 1.0 Date: 06 February 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 PhaseIV, 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 PhaseIV, 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 PhaseIV, Peenya
KARNATAKA
560058
India |
| Phone |
9717887751 |
| Fax |
|
| Email |
ashok.m@healthiummedtech.com |
|
|
Source of Monetary or Material Support
|
| Healthium Medtech Limited |
|
|
Primary Sponsor
|
| Name |
Healthium Medtech Limited |
| Address |
472/D, 13th Cross, 4th Phase, Peenya Industrial AreaPhase 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 Sunil Kumar Dash |
AMRI Hospitals |
Room no 7, Ground floor OPD, Plot No. 1, Near Jayadev Vatika Park, Khandagiri, Bhubaneswar
Khordha
ORISSA |
9776206247
drsunil_dash@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AMRI Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M259||Joint disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable since its a observational retrospective study |
Not applicable since its a observational retrospective study |
| Intervention |
Not applicable since its a observational retrospective study |
Not applicable since its a observational retrospective study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Male/ Female Patients of 18 to 60 years of age.
2.Patients who underwent arthroscopic anterior cruciate ligament (ACL) reconstruction using the Sironix suture button and Peek Button between the period of August 2022 to January 2023.
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.
|
|
| ExclusionCriteria |
| Details |
1.Patients not responding to calls after three attempts and not interested to participate in the study.
2.Patients with injury to the same knee post ACL reconstruction procedure.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the function of the knee post ACL reconstruction |
One follow up after EC approval 6months to 3.5 years after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To assess the level of activity post ACL reconstruction
2)To assess the quality of life after ACL reconstruction
3)To assess the adverse events associated with knee arthroscopy procedures
|
One follow up after EC approval 6months to 3.5 years after surgery |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "31"
Final Enrollment numbers achieved (India)="31" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/05/2023 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Arthroscopy implants are used for fixation of the ACL grafts at the femoral and tibial sides. Numerous grafts in terms of fixed suture button, adjustable loop suture button, and interference screws made up of multiple materials will be used for the fixation. In this study, we would want to evaluate the functional outcomes in patients who underwent arthroscopic ACL reconstruction using Sironix suture button and Peek button. The available Patient data will be collected and assessed to evaluate the safety and effectiveness of the Sironix knee implant device. |