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CTRI Number  CTRI/2023/06/053438 [Registered on: 02/06/2023] Trial Registered Prospectively
Last Modified On: 24/07/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to assess success after shoulder surgery  
Scientific Title of Study   A randomized, multi center, parallel, open label study assessing clinical and functional outcomes after treatment of Rotator Cuff Tears using Knotted UHMWPE Suture PEEK Anchor and Knotted UHMWPE Suture PLDLA+Beta-TCP Anchor 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
HML-RCT-004-22 Version 01, 07 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

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, 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 = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
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 Patel Zulfikar M Husen  Byramjee Jeejeebhoy Medical College  Orthopedic OPD Room, New Civil Hospital, B.J. Medical College, Asarwa
Ahmadabad
GUJARAT 		 9601276972

dr.zulfikarpatel@yahoo.co.in 
Dr Girish Chandra  GCs Sports medicine & Multispeciality Hospital  Room no 1, Ground Floor, GS Ramakrishnaiah Main Rd, Vidyaranyapura 30/A, Vishweshwaranagar, Near St. Thomas School, Mysore south
Mysore
KARNATAKA 		 9986309071

girishchandrahospital@gmail.com 
Dr Prathap Kumar KR  Lakshmi Hospital  Department of Orthopedics, Diwans Road, Opposite to Diwans Ground
Ernakulam
KERALA 		 9895057554

pratkumar@hotmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Ethics Committee of BMCRI  Approved 
Institutional Ethics Committee BJMC and Civil Hospital  Approved 
Institutional Ethics Committee Sree Sudheendra Medical Mission  Approved 
Mandya Institute of Medical Sciences Institution 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  CEPTRE Knotted UHMWPE Suture PEEK Anchor  CEPTRE Knotted UHMWPE Suture PEEK 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  CEPTRE Knotted UHMWPE Suture PLDLA BTCP Anchor  CEPTRE Knotted UHMWPE Suture PLDLA BTCP Anchor is intended for soft tissue fixation to the bone. It will be a permanent implant and will not be removed. (Duration: Permanent implant)  
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Male/ female participants between ≥30 years and ≤ 70 of age at the time of consent
2.Participants with Rotator Cuff Tears requiring primary RCT repair
3.Participants/ Legally Acceptable Representative who are willing to provide written Informed Consent and comply with study procedures
 
 
ExclusionCriteria 
Details  1.Participants with evidence of osteoarthritis in the shoulder
2.Participants with evidence of infection, tumor or necrosis in the shoulder
3.Participants who had undergone previous surgery of the same shoulder
4.Participants having any contraindications for undergoing MRI
5.Participants with HbA1c ˃ 9%. (Clinical laboratory reports up to 3 months will be considered valid otherwise participants will undergo blood investigation for HbA1C)
6.Participants with a history of deep vein thrombosis (DVT)
7.Participants who are smokers (smoking ˃ 20 cigarettes/day)
8.Participants with sensitivity to PEEK/ PLDLA-BTCP material
9.Participants with any condition which makes the subject unsuitable for study participation which as per the investigator would jeopardize the outcome of the trial or participant who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol.
10.Pregnant and lactating female at the time of screening
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.To assess overall functional outcomes in each cohort of Knotted UHMWPE Suture PEEK Anchor and Knotted UHMWPE Suture PLDLA and B TCP Anchor  Time frame Screening or Baseline, month 3, month 6, month 12, month 18 and month 24 
 
Secondary Outcome  
Outcome  TimePoints 
1.To assess the patient reported outcomes in each cohort of Knotted UHMWPE Suture PEEK Anchor and Knotted UHMWPE Suture PLDLA and B TCP Anchor during RCT repair
2.To assess the failure rate in each cohort of Knotted UHMWPE Suture PEEK Anchor and Knotted UHMWPE Suture PLDLA and B TCP Anchor during RCT repair
3.To assess change in quality-of-life post RCT repair using Sironix all suture anchor in each cohort of Knotted UHMWPE Suture PEEK Anchor and Knotted UHMWPE Suture PLDLA and B TCP Anchor
4.To assess recovery period in patients of each cohort of Knotted UHMWPE Suture PEEK Anchor and Knotted UHMWPE Suture PLDLA and B TCP Anchor
5.To assess the duration of surgery
6.To assess the overall intraoperative handling of Knotted UHMWPE Suture PEEK Anchor and Knotted UHMWPE Suture PLDLA and B TCP Anchor
7.To assess the incidence of residual risks and safety of Knotted UHMWPE Suture PEEK Anchor and Knotted UHMWPE Suture PLDLA and B TCP Anchor

 		 Time frame Screening or Baseline,Day of Surgery, Day 15, month 3, month 6, month 12, month 18 and month 24 
 
Target Sample Size   Total Sample Size="74"
Sample Size from India="74" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="74" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   09/06/2023 
Date of Study Completion (India) 01/04/2026 
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
Modification(s)  

Arthroscopic rotator cuff repair (RCR) has evolved into one of the most common orthopedic surgical procedures worldwide. Suture anchors are one of the most important devices in rotator cuff arthroscopic repair, their design and composition continues to improve, and different surgical acts can be associated to glean the final result. CEPTRE Knotted UHMWPE Suture PEEK Anchor and CEPTRE Knotted UHMWPE Suture PLDLA and B TCP anchor are intended for soft tissue fixation to the bone. In current study we plan to evaluate and compare efficacy of both devices via change in ASES, Constant Murley shoulder outcome scores, Penn-Shoulder Score, SANE score, SST score and quick DASH score. Duration of surgery, RCT repair failure assessment and time to recovery will also be done as a part of efficacy assessment. Efficacy and safety of both devices will also be compared. Clinical data collected through this study will be of great benefit to the research field and potentially will be beneficial to the society.

 
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