| CTRI Number |
CTRI/2023/04/051751 [Registered on: 19/04/2023] Trial Registered Prospectively |
| Last Modified On: |
09/02/2026 |
| 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 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 Suspensory Tibial Fixation with Open and Closed Peek Button |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HML-ACL-002-22; 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
|
| No of Sites = 4 |
| 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 Vivek Mahajan |
Indian Spinal Injuries Centre |
OPD, Department of Orthopaedics, Sector C, Vasant Kunj, Opp. Vasant Valley School,
New Delhi
DELHI |
9650886434
mvivek@hotmail.com |
| Dr Tapasa Kumar Panigrahi |
S.C.B. Medical College |
Room no 1, OPD Block, Department of orthopedics, Manglabag
Cuttack
ORISSA |
9938735955
drtapaspanigrahi300677@gmail.com |
| Dr Hari Kumar G |
SP Fort Hospital |
Room no 1, Department of Orthopaedics, Unit-1 of SP FORT HOSPITAL, Fort
Thiruvananthapuram
KERALA |
9447388272
dr.g.harikumar@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institutional Ethcis committee, SCB Medical College |
Approved |
| Institutional Ethics Committee, Cosmopolitan Hospital |
Approved |
| Institutional Ethics Committee, Indian Spinal Injuries Center |
Approved |
| Institutional Ethics Committee, Sanjay Gandhi post Graduate Institute of Medical Sciences |
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 |
Peek button-closed (T-Buttonâ„¢ A PEEK Adjustable Loop Button) |
Peek button-closed (T-Buttonâ„¢ A PEEK Adjustable Loop Button) is used for tibial fixation of the graft and will stay permanently in the body after implantation (Duration: Permanent implant) |
| Comparator Agent |
Peek button-open (T- Buttonâ„¢ S PEEK Open Button and Free Adjustable Loop) |
Peek button-open (T- Buttonâ„¢ S PEEK Open Button and Free Adjustable Loop) is used for tibial fixation of the graft and 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 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 Peek button-open and Peek button-closed. |
Screening, month 3, month 6, month 12, month 18 and month 24 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the clinical symptoms and activity level in each cohort of Peek button-open and Peek button-closed from baseline (pre-surgery).
2. To assess the failure rate of ACL reconstruction in each cohort of Peek button-open and Peek button-closed.
3. To assess change in quality of life in patients of each cohort of Peek button-open and Peek button-closed.
4. To assess recovery period in patients of each cohort of Peek button-open and Peek button-closed.
5. To assess the duration of surgery.
6. To assess clinical condition of the knee.
7. To assess the overall intraoperative handling of Peek button-open and Peek button-closed.
8. To assess the incidence of residual risks and safety of peek button open and Peek button closed.
9. To assess the condition of the graft and implants.
10. To compare the results of all primary and secondary objectives between the two cohorts, Peek button-open Vs Peek button-closed. |
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)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
27/04/2023 |
| Date of Study Completion (India) |
11/11/2025 |
| 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. |