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CTRI Number  CTRI/2023/04/051727 [Registered on: 18/04/2023] Trial Registered Prospectively
Last Modified On: 03/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   A study to assess result after knee surgery 
Scientific Title of Study   A Prospective, Multicentric, Single-arm Study to evaluate the effectiveness and safety in Patients undergoing Arthroscopic Anterior Cruciate Ligament (ACL) Reconstruction Procedure using Fixed Loop UHMWPE Suture Titanium Button and Titanium Interference Screw. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
SIRONIX-006-22; Version 1; date 11/01/23   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

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


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


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,Bangalore KARNATAKA 560058 India 
 
Primary Sponsor  
Name  Healthium Medtech Limited 
Address  472D, 13th cross, 4th phase, Peenya Industrial Area, BangaloreKARNATAKA 560058 India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Tanmay Datta  IPGME&R and SSKM Hospital   OPD room, Department of Orthopedics, 244, A. J. C. Bose Road, Kolkata-700020
Kolkata
WEST BENGAL 		 9433012422

dattat847@gmail.com 
Dr Siddharth M Shetty  K S Hegde Medical College  K S Hegde Medical College
Dakshina Kannada
KARNATAKA 		 9448501350

drshettybs@gmail.com 
Dr Jayesh Vaza   Sheth L G Hospital  Sheth L G Hospital, New Building first floor Orthopaedic OPD 1
Ahmadabad
GUJARAT 		 8780517388

jayeshbhoomi@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
AMC MET Ethics Committee, Sheth L.G General Hospital & AMC MET Medical College  Approved 
IPGMER Research Oversight Committee  Approved 
Nitte Deemed to be University Central Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: M999||Biomechanical lesion, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fixed loop UHMWPE suture Titanium button (INFILOOP® Titanium fixed loop button) and Titanium Interference Screw (HELYSIS® Titanium Interference screw)  Fixed loop UHMWPE suture Titanium button (INFILOOP® Titanium fixed loop button) is used for soft tissue fixation to the femoral end and Titanium Interference Screw (HELYSIS® Titanium Interference screw) is used for soft tissue fixation to the tibial end. Both devices will be permanent implants and will not be removed. (Duration: Permanent implant) 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1.Male and female subjects between 18 to 45 years of age.
2.Subjects with ACL injury with or without associated meniscus injuries requiring primary ACL reconstruction surgery.
3.Subject willing to give written informed consent to participate in the study.

 
 
ExclusionCriteria 
Details  1.Subjects with Posterior Cruciate Ligament injury, and/or Collateral ligament injury.
2.Subjects with known hypersensitivity to titanium and/or UHMWPE suture.
3.Subjects with BMI ≥35 kg/m2
4.Subjects with a history of previous knee surgery
5.Subjects with the insufficient quantity or skeletally immature bone.
6.Subjects with active infection or blood supply limitations.
7.Subjects with pathological conditions of the bone or soft tissues that would impair secure fixation.
8.Subjects with conditions, which would limit the subject’s ability or willingness to restrict activities or follow directions during the healing period.
9.Subjects having any condition that could affect healing (Infections, regular use of Corticosteroids, Diabetes – HbA1C ≥ 10).
10.Subjects with a history of heavy smoking (> 20 cigarettes/day) within the last 6 months.
11.Subjects with a medical or physical condition that, in the opinion of the investigator, would preclude safe subject participation in the study.
12.Subjects who are pregnant or lactating at the time of screening
 
 
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 of the knee after ACL Reconstruction surgery from baseline to 24 months post-surgery   Screening, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery, 18 months post-surgery, and 24 months post-surgery 
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate the condition of the knee (clinical and functional outcome) from baseline to 24 months post-surgery
2. To evaluate the knee stability from baseline to 24 months post-surgery
3. To evaluate the level of activity from baseline to 24 months post-surgery
4. To evaluate the health, symptoms, and functionality of the knee and quality of life from baseline to 24 months post-surgery
5. To evaluate the ACL reconstruction failure rate
6. To evaluate the time to recovery after ACL Reconstruction surgery.
7. To evaluate the overall intraoperative handling of the titanium suture button and titanium interference screw
8. To evaluate the graft and implant condition after ACL Reconstruction surgery
9. To evaluate the adverse events after Arthroscopic Anterior Cruciate Ligament (ACL) Reconstruction and safety of titanium suture button and titanium interference screw from baseline to 24 months post-surgery 		 Screening, day of surgery, Discharge visit, 15 days post surgery, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery, 18 months post-surgery, and 24 months post-surgery 
 
Target Sample Size   Total Sample Size="43"
Sample Size from India="43" 
Final Enrollment numbers achieved (Total)= "43"
Final Enrollment numbers achieved (India)="43" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   27/04/2023 
Date of Study Completion (India) 04/05/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="6"
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 the 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. However, there is limited information available on the performance outcome and safety of the products in the real time clinical setting in India. Therefore, there is a need for conducting prospective post-marketing study to obtain the data on product performance outcome and clinical safety. The objective of the study is to evaluate the effectiveness and safety in patients who undergone arthroscopic ACL reconstruction using Fixed Loop UHMWPE Suture Titanium Button and Titanium Interference Screw in 43 eligible subjects as per the study protocol.

 
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