| CTRI Number |
CTRI/2025/09/095352 [Registered on: 24/09/2025] Trial Registered Prospectively |
| Last Modified On: |
23/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the safety and performance of sutures used to repair meniscus in knee arthroscopy patients. |
|
Scientific Title of Study
|
A Prospective Post Market Clinical Follow up Study to Evaluate the Safety and Performance of the Meniscus Repair System |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CR_PMCF/P_22 Version 1.0 Dated 12 May 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohd Aslam |
| Designation |
Clinical Research Manager |
| Affiliation |
Auxein Medical Pvt Ltd |
| Address |
Plot No 168-169-170
Phase IV
Sector 56
HSIIDC
Industrial Estate Kundli
Sonipat
HARYANA
131028
India |
| Phone |
7419660141 |
| Fax |
|
| Email |
m.aslam@auxeinmedical.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohd Aslam |
| Designation |
Clinical Research Manager |
| Affiliation |
Auxein Medical Pvt Ltd |
| Address |
Plot No 168-169-170
Phase IV
Sector 56
HSIIDC
Industrial Estate Kundli
HARYANA
131028
India |
| Phone |
7419660141 |
| Fax |
|
| Email |
m.aslam@auxeinmedical.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohd Aslam |
| Designation |
Clinical Research Manager |
| Affiliation |
Auxein Medical Pvt Ltd |
| Address |
Plot No 168-169-170
Phase IV
Sector 56
HSIIDC
Industrial Estate Kundli
HARYANA
131028
India |
| Phone |
7419660141 |
| Fax |
|
| Email |
m.aslam@auxeinmedical.com |
|
|
Source of Monetary or Material Support
|
| Auxein Medical Pvt Ltd
Plot No 168-169-170
Phase IV
Sector 57
HSIIDC
Industrial Estate Kundli
Sonipat 131028
Haryana
India |
|
|
Primary Sponsor
|
| Name |
Auxein Medical Pvt Ltd |
| Address |
Plot No 168-169-170
Phase IV
Sector 57
HSIIDC
Industrial Estate Kundli
Sonipat 131028
Haryana
India
|
| Type of Sponsor |
Other [Medical Device Company] |
|
|
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 Tirth Vyas |
Amreet Orthopedic Hospital |
Room No 4
Fourth Floor
Ananta Space
401-404
Jagatpur Rd Gota
Ahmedabad
Ahmadabad
GUJARAT |
9913347757
tirthortho@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rhythm Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M232||Derangement of meniscus due to oldtear or injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Meniscus suturing |
Follow up at following time points
6 week
3 month
6 month
12 month |
| Comparator Agent |
None |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting to orthopaedic OPD or emergency with meniscus tear confirmed through MRI scan. |
|
| ExclusionCriteria |
| Details |
1 Subjects with a disease entity or condition that could hinder healing and create unacceptable risk of fixation failure or complications such as known active cancer, neuromuscular disorder etc.
2 Subject with inadequate tissue coverage at the operative sites.
3 Patients with concomitant ligamentous injury.
4 Patient with history of meniscus surgery.
5 Patients with known history of metal allergies.
6 Patients with documented mental disorders.
7 Patients with life-threatning conditions.
8 Subjects who are incarcerated or have pending incarceration.
9 Associated other fractures which may interfere the rehabilitation and timely surgical fixation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Patient reported outcomes (IKDC and KOOS) will be recorded at pre-operative visit and post-operative follow up visits to evaluate the change.
2. Number of individuals who have returned to pre-injury level of activities of daily living/sports activities will be recorded at each post-operative follow up visit.
|
6 week
3 month
6 month
12 month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse event (AE), and serious adverse event (SAE), if any will be recorded at each post-operative follow up visit to assess the meniscus repair system. |
6 week
3 month
6 month
12 month |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
11/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 is a multi-centric prospective post market clinical follow up study. The study is being done to collect more data on safety and performance of the implants used to repair meniscal tear. The specific aim of the study is to assess safety and performance of meniscus repair system. A total of 40 patients will be enrolled in the study. Total duration of study is two years. |