| CTRI Number |
CTRI/2026/01/100412 [Registered on: 06/01/2026] Trial Registered Prospectively |
| Last Modified On: |
06/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To assess the Safety and Functional outcomes of Adjustable Loop Suture Button and PEEK Interference Screw during Arthroscopic ACL Reconstruction |
|
Scientific Title of Study
|
A Single Centre Study to Assess the Safety and Functional Outcomes after Arthroscopic Anterior Cruciate Ligament- ACL Reconstruction Procedure Using Adjustable Loop Suture Button and PEEK Interference Screw |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kalpesh Maheshchandra Trivedi |
| Designation |
PRINCIPAL INVESTIGATOR |
| Affiliation |
Aadya Arthroscopy and OrthoSports Hospital |
| Address |
Room No 001
Department of Orthopedics
Aadya Arthroscopy and OrthoSports Hospital Vedanta Complex Usmanpura Ahmedabad Gujarat 380013 India
Room No 001
Department of Orthopedics
Aadya Arthroscopy and OrthoSports Hospital Vedanta Complex Usmanpura Ahmedabad Gujarat 380013 India
Ahmadabad
GUJARAT
380013
India |
| Phone |
9825281710 |
| Fax |
|
| Email |
drkalpesh@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalpesh Maheshchandra Trivedi |
| Designation |
PRINCIPAL INVESTIGATOR |
| Affiliation |
Aadya Arthroscopy and OrthoSports Hospital |
| Address |
Room No 001
Department of Orthopedics
Aadya Arthroscopy and OrthoSports Hospital Vedanta Complex Usmanpura Ahmedabad Gujarat 380013 India
Room No 001
Department of Orthopedics
Aadya Arthroscopy and OrthoSports Hospital Vedanta Complex Usmanpura Ahmedabad Gujarat 380013 India
Ahmadabad
GUJARAT
380013
India |
| Phone |
9825281710 |
| Fax |
|
| Email |
drkalpesh@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalpesh Maheshchandra Trivedi |
| Designation |
PRINCIPAL INVESTIGATOR |
| Affiliation |
Aadya Arthroscopy and OrthoSports Hospital |
| Address |
Room No 001
Department of Orthopedics
Aadya Arthroscopy and OrthoSports Hospital Vedanta Complex Usmanpura Ahmedabad Gujarat 380013 India
Room No 001
Department of Orthopedics
Aadya Arthroscopy and OrthoSports Hospital Vedanta Complex Usmanpura Ahmedabad Gujarat 380013 India
Ahmadabad
GUJARAT
380013
India |
| Phone |
9825281710 |
| Fax |
|
| Email |
drkalpesh@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Dr Kalpesh Maheshchandra Trivedi
Room No 001
Department of Orthopedics
Aadya Arthroscopy and OrthoSports Hospital Vedanta Complex Usmanpura Ahmedabad Gujarat 380013 India |
|
|
Primary Sponsor
|
| Name |
Dr Kalpesh Maheshchandra Trivedi |
| Address |
Room No 001
Department of Orthopedics
Aadya Arthroscopy and OrthoSports Hospital Vedanta Complex Usmanpura Ahmedabad Gujarat 380013 India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kalpesh Maheshchandra Trivedi |
Aadya Arthroscopy and OrthoSports Hospital |
Room No 001
Department of Orthopedics
Aadya Arthroscopy and OrthoSports Hospital Vedanta Complex Usmanpura Ahmedabad Gujarat 380013 India
Ahmadabad
GUJARAT |
09825281710
drkalpesh@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Conscience Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
PEEK interference screws |
PEEK interference screws is used for tibial fixation during ACLR procedure
Duration: Permanent implant |
| Intervention |
Adjustable Loop Suture Button |
Adjustable Loop Suture Button is used for femoral fixation during ACLR procedure
Duration: Permanent implant |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Male or 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 and or 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 gretaer than or equal to 35 kg m2
3.Participants who had undergone previous surgery in the same or contralateral knee
4.Participants with a history of deep vein thrombosis (DVT)
5.Participants with arthritis of same or contralateral knee
6.Participants with any condition which makes the subject unsuitable for study participation which as per the investigator would jeopardize the outcome of thetrial or participant who, in the judgment of the investigator, will be unlikely to comply with the requirements of this clinical investigation plan
7.Pregnant and lactating female 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 functional outcomes of the Knee post- ACL Reconstruction Procedure.
|
Screening/ Baseline, month 3, month 6, and month 12
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess the clinical symptoms and activity level
2.To assess the failure rate of ACL reconstruction
3.To assess the change in quality of life in patients
4.To assess the duration of surgery
5.To assess the overall intraoperative handling.
6.To assess the safety of the implants
|
1.Screening/ Baseline, month 3, month 6, and month 12
2.All visits after surgery including surgery day.
3.Screening/ Baseline,month 12
4.During surgery
5.During Surgery
6. All visits after surgery including surgery day
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
26/01/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This will be a Single Centre Study to Assess the Safety and Functional Outcomes after Arthroscopic Anterior Cruciate Ligament ACL Reconstruction Procedure Using Adjustable Loop Suture Button and PEEK Interference Screw with a follow-up of one year. |