| CTRI Number |
CTRI/2023/05/052434 [Registered on: 09/05/2023] Trial Registered Prospectively |
| Last Modified On: |
05/08/2025 |
| 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 Knotless PEEK Anchors with PEEK Tip & knotless PLDLA-B TCP Anchors with PEEK Tip |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HML-RCT-003-22 Version 01 Date 6th 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
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sunil Kumar Dash |
AMRI Hospitals Bhubaneswar |
Room No 7, Orthopedic OPD block, Plot No. 1, Near
Jayadev Vatika Park, Khandagiri,
Bhubaneswar
Khordha
ORISSA |
9776206247
drsunil_dash@yahoo.com |
| Dr Prathap Kumar KR |
Lakshmi Hospital |
Department of Orthopedics, Diwans Road, Opposite to Diwans Ground
Ernakulam
KERALA |
9895057554
pratkumar@hotmail.com |
| Dr G Ramesh |
Osmania General Hospital |
OPD block, Orthopedics OPD, Begum Bazar, Afzal Gunj
Hyderabad
TELANGANA |
9848034265
drrameshgaripalli@yahoo.co.in |
| Dr Taufiq Panjwani |
Shalby Multi Specialty Hospitals |
9th Floor, Sarkhej - Gandhinagar Hwy, opp.
Karnavati Club, Ramdev Nagar
Ahmadabad
GUJARAT |
9820616512
taufiqpanjwani@gmail.com |
| Dr Neel Mahendra Bhavsar |
Smt N H L Municipal Medical College |
Room No 1, Orthopedic OPD, Pritan Rai Cross Road, Ellisbridge
Ahmadabad
GUJARAT |
9638040954
drnmbortho@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Ethics Committee Shalby Limited |
Approved |
| Institutional Ethics Committee AMRI |
Approved |
| Institutional Ethics Committee NHLIEC |
Approved |
| Institutional Ethics Committee Osmania Hospital |
Approved |
| Institutional Ethics Committee Sree Sudheendra Medical Mission |
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 |
| Intervention |
VIPLOK Knotless PEEK Anchor with PEEK Tip |
VIPLOK Knotless PEEK Anchor with PEEK Tip is intended for soft tissue fixation to the bone, and once implanted will not be removed. |
| Comparator Agent |
VIPLOK Knotless PLDLA-BTCP Anchor with PEEK Tip |
VIPLOK Knotless PLDLA-BTCP Anchor with PEEK Tip is intended for soft tissue fixation to the bone, and once implanted will not be removed. |
|
|
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 ˃ 9% HbA1c (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 Knotless PEEK Anchors with PEEK tip & Knotless PLDLA-B TCP Anchors with PEEK Tip |
Time frame Screening/ 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 Knotless PEEK Anchors with PEEK tip & Knotless PLDLA-BTCP Anchors with PEEK Tip during RCT repair.
2.To assess the failure rate in each cohort of Knotless PEEK Anchors with PEEK tip & Knotless PLDLA-BTCP Anchors with PEEK Tip during RCT repair.
3.To assess change in quality-of-life post RCT repair using Sironix all suture anchor in each cohort of Knotless PEEK Anchors with PEEK tip & Knotless PLDLA-BTCP Anchors with PEEK Tip
4.To assess recovery period in patients of each cohort of Knotless PEEK Anchors with PEEK tip & Knotless PLDLA-BTCP Anchors with PEEK Tip
5.To assess the duration of surgery.
6.To assess the overall intraoperative handling of Knotless PEEK Anchors with PEEK tip & Knotless PLDLA-BTCP Anchors with PEEK Tip
7.To assess the incidence of residual risks and safety of Knotless PEEK Anchors with PEEK Tip & Knotless BTCP Anchors with PEEK Tip |
Time frame Screening/ 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)= "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)
|
18/05/2023 |
| 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
|
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. VIPLOK PEEK Knotless Screw/Wedge anchors
(PEEK Tip) and VIPLOK PLDLA and B TCP Knotless Screw or wedge (PEEK Tip) 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. |