| CTRI Number |
CTRI/2023/07/055473 [Registered on: 21/07/2023] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| 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 Bankarts Repair using Knotted UHMWPE Suture Anchor. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SIRONIX-008-22; 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
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
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pulak Sharma |
Apex Trauma Center, Sanjay Gandhi Post Graduate Institute of Medical Sciences |
OPD block, Speciality of Orthopaedics, Vrindavan Yojna SEC 17
Lucknow
UTTAR PRADESH |
8718043236
drpulaksharma@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 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 Rahul S Thokaloath |
Government Medical College, Thiruvananthapuram |
Room no 300, Department of Orthopedics, 2nd Floor, Casuality Block
Thiruvananthapuram
KERALA |
7558879863
rahul.thokaloath@gmail.com |
| Dr Rohan G Bansal |
KIMS-Kingsway Hospital |
Room No 1, Orthopedic OPD, No 44 Parwana Bhawan, Kingsway
Nagpur
MAHARASHTRA |
9420086803
drbansalrohan@gmail.com |
| Dr Vijayaraj Kannan |
Kumaran Hospitals and Rela Institute |
Room no 1, Ground Floor OPD, Department of Orthopedics, No 214, E.V.R. Periyar Salai (P.H. Road), Kilpauk
Chennai
TAMIL NADU |
8056023632
drkvraj@gmail.com |
| Dr Swapnil Nalge |
New Civil Hospital |
Room No 5, OPD Block, Department of Orthopedics, New Civil Hospital, Ring Road, Opp Stem Cell Hospital, Khatodra Wadi, Majura Gate
Surat
GUJARAT |
8238326333
swapnil.nalge@gmail.com |
| Dr Vineet Jain |
VMMC and Safdarjung Hospital |
Room no 810, 8th Floor, Department of Sports Injury Centre, Ansari Nagar West 110029
New Delhi
DELHI |
9810324416
vineet.ortho@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Dr. Rela Institute and Medical Centre, No.7, CLC Works Road, Chrompet, Chennai, Tamil Nadu |
Approved |
| Ethics Committee of BMCRI |
Approved |
| Human Ethics Committee, Medical College, Thiruvananthapuram |
Approved |
| Human Research Ethics Committee, Government Medical College, Majuragate, Surat, Gujarat |
Approved |
| Institutional Ethics Committee BJMC and Civil Hospital |
Approved |
| Institutional Ethics Committee, Sanjay Gandhi post Graduate Institute of Medical Sciences |
Approved |
| Kingsway Hospital Ethics Committee |
Approved |
| VMMC and Safdarjung Hospital IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M999||Biomechanical lesion, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Stativ Knotted UHMWPE Suture Anchor |
Stativ Knotted UHMWPE Suture Anchor is used for soft tissue fixation by the use of sutures to bone. (Duration: Its a permanent implant and will not be removed from the body) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Male and female subjects between 18 to 40 years of age.
2.Subjects with Bankarts lesion requiring primary Arthroscopic Bankarts repair surgery.
3.Subjects willing to give written informed consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1.Subjects with BMI ≥35 kg/m2.
2.Subjects with history of any surgery to the same shoulder.
3.Subjects with active infection or blood supply limitations.
4.Subjects with pathological conditions of bone or soft tissue that would impair secure fixation.
5.Subjects with known hypersensitivity to UHMWPE
6.Subjects with conditions, which would limit the subjects ability or willingness to restrict activities or follow directions during the healing period.
7.Subjects having any condition that could affect healing (eg. Infections, Regular use of Corticosteroids, Diabetes – HbA1C ≥ 10).
8.Subjects with 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 assess the shoulder function and stability post Bankarts repair using Knotted UHMWPE Suture Anchor |
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 assess the functional outcomes post Bankarts repair using Knotted UHMWPE Suture Anchor
2.To assess the instability after Bankart’s repair using Knotted UHMWPE Suture Anchor
3.To assess the failure rate of Bankart’s repair using Knotted UHMWPE Suture Anchor
4.To assess change in quality of life post Bankarts repair using Knotted UHMWPE Suture Anchor
5.To assess the time to recovery post Bankarts repair using Knotted UHMWPE Suture Anchor
6.To assess the overall intraoperative handling of Knotted UHMWPE Suture Anchor
7.To evaluate the ligament and implant condition after Arthroscopic Bankarts repair surgery
8.To assess the incidence of residual risks and safety of Knotted UHMWPE Suture Anchor |
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="44"
Sample Size from India="44"
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)
|
31/07/2023 |
| 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
|
Arthroscopic procedures
theoretically offer advantages of the decreased loss of motion, decreased
morbidity, avoidance of subscapularis tenotomy, and the capacity to address
concomitant intra-articular pathology, studies have shown a faster return to preoperative
muscle strength. Stativ
Knotted UHMWPE Suture Anchor also referred as All suture anchor is made up of
Non-Absorbable Ultra-high-molecular-weight polyethylene (UHMWPE) braided suture,
a fixation device intended to provide secure fixation of soft tissue to 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 study is to
evaluate the effectiveness and safety in patients who undergone arthroscopic
Bankarts Repair using Knotted UHMWPE Suture Anchor in 44 eligible subjects as
per the study protocol. |