| CTRI Number |
CTRI/2023/04/051843 [Registered on: 21/04/2023] Trial Registered Prospectively |
| Last Modified On: |
03/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to assess result after knee surgery |
|
Scientific Title of Study
|
A Randomized, Multi Center, Parallel, Open Label Study Assessing Clinical and Functional Outcomes After Anterior Cruciate Ligament (ACL) Reconstruction Procedure Using Interference Tibial Fixation with PEEK Interference Screw and PLDLA-BTCP Interference Screw |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HML-ACL-003-22; Version 1; date 09/01/2023 |
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 Nikunj Maru |
P.D.U. Medical College and Hospital |
O.P.D. No.: 7, New Buildings, P.D.U. Medical College and Hospital
Rajkot
GUJARAT |
9879681202
dr.nikunj83@gmail.com |
| Dr Krunal Shirishbhai Shah |
Advanced Surat Traumatology & Orthopedic Surgery Hospital (ASUTOSH) |
Rajashri Hall Road, beside Kshetrapal Hanuman Temple,Majura Gate
Surat
GUJARAT |
7600004080
dr_krunalshah@yahoo.com |
| Dr Ranajit Panigrahi |
Kalinga Hospital Ltd |
Nalco Square, Maitri Vihar, NALCO Nagar, Chandrasekharpur, Bhubaneshwar
Khordha
ORISSA |
9777037435
ranajitpanigrahi@gmail.com |
| Dr Dhananjaya Sabat |
Maulana Azad Medical College & Lok Nayak Hospital |
Room no 610, 6 floor, Orthopaedic Block, Lok Nayak Jai Prakash Hospital
New Delhi
DELHI |
9811258932
drdsabat@gmail.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 |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| IEC-MMC and RI and Associated Hospital |
Approved |
| Kalinga Hospital Limited Ethics Committee |
Approved |
| Maulana Azad Medical College |
Approved |
| Pandit Deendayal Upadhyay Govt. Medical College |
Approved |
| VMH Health care and Research Center LLP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Interference screw with PEEK material (HELYSIS®: PEEK Interference Screw) |
Interference screw with PEEK material (HELYSIS®: PEEK Interference Screw) is used for fixation of tissue, including ligament or tendon to bone, or a bone/tendon to bone. It will stay permanently in the body after implantation (Duration: Permanent implant) |
| Comparator Agent |
Interference screw with PLDLA-BTCP material (HELYSIS®: PLDLA-BTCP Interference Screw) |
Interference screw with PLDLA-BTCP material (HELYSIS®: PLDLA-BTCP Interference Screw) is used for fixation of tissue, including ligament or tendon to bone, or a bone/tendon to bone. It will stay permanently in the body after implantation (Duration: Permanent implant) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Male/ female participants between ≥18 years and ≤ 45 years of age at the time of consent
2.Participants with traumatic ACL tears with or without associated meniscus injuries requiring primary ACL reconstruction surgery
3.Participants/ Legally Acceptable Representative who are willing to provide written Informed Consent and comply with study procedures
|
|
| ExclusionCriteria |
| Details |
1.Participants with lateral/medial collateral ligament injury or posterior cruciate ligament injury
2.Participants with BMI ≥35 kg/m2
3.Participants who had undergone previous surgery in the same or contralateral knee
4.Participants with HbA1c ˃ 9% (Clinical laboratory reports up to 3 months will be considered valid otherwise participants will undergo blood investigation for HbA1C)
5.Participants who are smokers (smoking ˃20 cigarettes/day)
6.Participants with sensitivity to PEEK/PLDLA/B-TCP material
7.Participants with a history of deep vein thrombosis (DVT)
8.Participants with arthritis of same or contralateral knee
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 clinical investigation plan
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 functional outcomes of Knee in each cohort of Interference screw with PEEK material and PLDLA-BTCP material. |
Screening, month 3, month 6,month 12, month 18 and month24 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess the clinical symptoms and activity level in each cohort of Interference screw with PEEK material and PLDLA-BTCP material.
2.To assess the failure rate of ACL reconstruction in each cohort of Interference screw with PEEK material and PLDLA-BTCP material.
3.To assess change in quality of life in patients of each cohort of Interference screw with PEEK material and PLDLA-BTCP material.
4.To assess recovery period in patients of each cohort of Interference screw with PEEK material and PLDLA-BTCP material.
5.To assess the duration of surgery.
6.To assess clinical condition of the knee.
7.To assess the overall intraoperative handling of Interference screw with PEEK material and PLDLA-BTCP material.
8.To assess the incidence of residual risks and safety of Interference screws with PEEK material and PLDLA-BTCP material.
|
Screening, Day of surgery, Discharge visit, Day 15, month 3, month 6,month 12, month 18 and month 24 |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
27/04/2023 |
| Date of Study Completion (India) |
01/05/2026 |
| 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
|
In current study we plan to evaluate and compare efficacy of both devices via change in IKDC, Modified Cincinnati Rating System Questionnaire, Lysholm knee score, Tegner activity scale scores, SANE and modified KOOS scale scores. Duration of surgery, ACL reconstruction 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. |