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CTRI Number  CTRI/2023/04/052027 [Registered on: 27/04/2023] Trial Registered Prospectively
Last Modified On: 13/09/2024
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 shoulder surgery 
Scientific Title of Study   A Prospective, Multicentric, Single-arm Study to evaluate the effectiveness and safety in Patients undergoing Arthroscopic Rotator Cuff Tear Repair Using Knotted UHMWPE Suture Titanium Anchor. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
SIRONIX-007-22; version 1; date 24/01/23  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

Bangalore
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

Bangalore
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, Bangalore KARNATAKA 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 = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nitesh Gahlot  All India Institute of Medical Sciences (AIIMS)  Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Basni, Jodhpur, Rajasthan 342005.
Jodhpur
RAJASTHAN 		 9116096665

doc.nitesh@gmail.com 
Dr Preetham N  Bangalore Medical College and Research Institute  OPD block, Department of Orthopedics, Fort, Krishna Rajendra Road, Opposite KR Market
Bangalore
KARNATAKA 		 9480301805

preetham_1875@yahoo.co.in 
Dr Karnav Arvind Panchal  EPIC Hospital  EPIC Hospital, Unit of Vatsalya Healthcare LLP, Empire Doctor House, Opp Kargil Petrol Pump, S G Highway, Ahmedabad, Gujarat – 380060
Ahmadabad
GUJARAT 		 9879010009

karnav1985@yahoo.com 
Dr Arun G R  Mysore Medical College and Research Institute  Room no 10, Orthopedic OPD, Irvin Road, Next to railway station
Mysore
KARNATAKA 		 9003343337

drgrarun@gmail.com 
Dr Aditya R Bothra  Ortho Avenue Hospital  7th Floor, Shri Radhe Heights, Opp. Neeti Gaurav Complex, Lokmat Square, Ramdaspeth
Nagpur
MAHARASHTRA 		 7219246666

ady8181@gmail.com 
Dr Bharat B Sutariya   Param Hospital  Room No 1, Orthopedic OPD, Canal (BRTS) Rd., Nr. Polaris Mall, Punagam
Surat
GUJARAT 		 9925027645

drbharat_b20@yahoo.co.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Bangalore Medical College and Research Institute  Approved 
Epic Hospital Institutonal Ethics Committee  Approved 
Gillurkar Hospital Ethics Commitee  Approved 
IEC-MMC and RI and Associated Hospital   Approved 
Institutional Ethics committee, All India Institute of Medical Sciences (AIIMS), Jodhpur  Approved 
VMH Health care and Research Center LLP  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  CEPTRE Knotted UHMWPE Suture Titanium Anchor  CEPTRE Knotted UHMWPE Suture Titanium Anchor is intended for soft tissue fixation to the bone. It will be a permanent implant and will not be removed. (Duration: Permanent implant)  
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Male and female subjects between 30 to 70 years of age.
2.Subjects with rotator cuff tear requiring primary arthroscopic rotator cuff tear repair surgery.
3.Subject willing to give written informed consent to participate in the study.
 
 
ExclusionCriteria 
Details  1.Subjects with BMI ≥35 kg/m2
2.Subjects with a history of any surgery to the same shoulder.
3.Subjects with active infection or blood supply limitations.
4.Subjects with pathological conditions of the bone or soft tissues that would impair secure fixation.
5.Subjects with known hypersensitivity to titanium or UHMWPE.
6.Subjects with conditions, which would limit the subject’s ability or willingness to restrict activities or follow directions during the healing period.
7.Subjects having any condition that could affect healing (Infections, regular use of Corticosteroids, Diabetes – HbA1C ≥ 10).
8.Subjects with a history of heavy smoking (> 20 cigarettes/day) within the last 6 months.
9.Subjects with a medical or physical condition that, in the opinion of the investigator, would preclude safe subject participation in the study.
10.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 shoulder after Arthroscopic Rotator Cuff Tears Repair from baseline to 24 months post-surgery.  Baseline, 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 shoulder (clinical and functional outcome) from baseline to 24 months post-surgery.
2.To evaluate the quality of life from baseline to 24 months post-surgery.
3.To evaluate the shoulder pain and function from baseline to 24 months post-surgery.
4.To evaluate the Arthroscopic Rotator Cuff Tears repair failure rate.
5.To evaluate the time to recovery after Arthroscopic Rotator Cuff Tears repair surgery.
6.To evaluate the overall intraoperative handling of the Knotted UHMWPE Suture Titanium Anchor.
7.To evaluate the rotator cuff and implant condition after Arthroscopic Rotator Cuff Tears repair surgery.
8.To evaluate the adverse events after Arthroscopic Rotator Cuff Tears Repair and safety of the Knotted UHMWPE Suture Titanium Anchor from baseline to 24 months post-surgery.

 		 Day of surgery, Day of Discharge, 15th day 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)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   04/05/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Surgical techniques have evolved from open to arthroscopic procedures. The development of suitable arthroscopic implants has been critical to the success of arthroscopic tissue repair. The newer implants continue to show promising characteristics. Knotted suture anchors provide the highest attachment strength possible for a wide variety of applications making technically demanding shoulder procedures simpler, safer, and more reproducible. CEPTRE Knotted UHMWPE Suture Titanium Anchor is available in Threaded option made of knotted anchor preloaded on a disposable inserter assembly intended for fixation of suture/ tape to bone. The implant is supplied sterile ready to use. It is intended for soft tissue fixation to the bone. However, there is limited information available on the performance outcome and safety of the product in the real time clinical setting. 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 post marketing study is to evaluate the effectiveness and safety in patients who undergo Arthroscopic Rotator Cuff Tears Repair using Knotted UHMWPE Suture Titanium Anchor in 43 eligible subjects as per the study protocol.


 
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