| CTRI Number |
CTRI/2025/09/094473 [Registered on: 09/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of knee joint repair by arthroscopy system |
|
Scientific Title of Study
|
A Prospective Post Market Clinical Follow up Study to Evaluate the Safety and Performance of the ACL Repair System |
| Trial Acronym |
PMCF_ACL Repair |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
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 Number 168-169-170
Phase IV
Sector 56
HSSIDC
Industrial Estate Kundli
Sonipat
HARYANA
131028
India |
| Phone |
7419660141 |
| Fax |
|
| Email |
clinical2@auxeinmedical.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohd Aslam |
| Designation |
Clinical Research Manager |
| Affiliation |
Auxein Medical Pvt Ltd |
| Address |
Plot Number 168-169-170
Phase IV
Sector 56
HSSIDC
Industrial Estate Kundli
HARYANA
131028
India |
| Phone |
7419660141 |
| Fax |
|
| Email |
clinical2@auxeinmedical.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohd Aslam |
| Designation |
Clinical Research Manager |
| Affiliation |
Auxein Medical Pvt Ltd |
| Address |
Plot Number 168-169-170
Phase IV
Sector 56
HSSIDC
Industrial Estate Kundli
HARYANA
131028
India |
| Phone |
7419660141 |
| Fax |
|
| Email |
clinical2@auxeinmedical.com |
|
|
Source of Monetary or Material Support
|
| Auxein Medical Pvt Ltd
Plot Number 168-169-170
Phase IV
Sector 56
HSIIDC
Intustrial Estate Kundli
Sonipat Haryana India
|
|
|
Primary Sponsor
|
| Name |
Auxein Medical Pvt Ltd |
| Address |
Plot Number 168-169-170
Phase IV
Sector 56
HSIIDC
Intustrial Estate Kundli
Sonipat 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 number 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: S835||Sprain of cruciate ligament of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ACL reconstruction implants |
Study participants will be followed at 6 week 3 month 6 month and 12 month |
| Comparator Agent |
None |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients with confirmed ACL injury and who are planned for ACL repair through arthroscopy surgery. |
|
| ExclusionCriteria |
| Details |
1 Patients 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 Patient has inadequate tissue coverage of the operative site.
3 Patients with concomitant meniscus or soft tissue injury.
4 Patient with history of effected ACL surgery
5 Patients with known history of metal allergies
6 Patients with documented mental disorders
7 Patients with life-threatning conditions
8 Patients 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 |
| Performance of Auxilock ACL Repair System will be assessed by improvement in KOOS score from pre-operative to post-operative follow-up visits |
6 week
3 month
6 month
12 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Visual analogue scale (VAS) score will be recorded at pre-operative visit and post-operative follow up visits for assessment of improvement in pain
2 Assessment of safety of the ACL repair system will be assessed by analysing complications and serious/adverse events recorded at post-operative follow up visits |
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)
|
25/09/2025 |
| 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 PMCF study. The study aims to assess safety and performance of ACL repair system. A total of 40 patients will be enrolled in the study. Total duration of study is two years. |