| CTRI Number |
CTRI/2025/01/079716 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
ACLR with suspensory and interference fixation |
|
Scientific Title of Study
|
A Single Centre, Prospective, Randomized, Open Label Study Assessing Clinical and Functional Outcomes After Anterior Cruciate Ligament (ACL) Reconstruction Procedure Using Suspensory Tibial Fixation and Interference Tibial Fixation |
| 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 Rudra Prasad M S |
| Designation |
Consultant Orthopaedic and Robotic Joint Replacement Surgery |
| Affiliation |
SPARSH Super Specialty Hospital |
| Address |
Room no 002
Department of Orthopaedics
146 Infantry Road Vasanth Nagar
Bangalore
KARNATAKA
560001
India |
| Phone |
9845287827 |
| Fax |
|
| Email |
rudraprasad173@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rudra Prasad M S |
| Designation |
Consultant Orthopaedic and Robotic Joint Replacement Surgery |
| Affiliation |
SPARSH Super Specialty Hospital |
| Address |
Room no 002
Department of Orthopaedics
146 Infantry Road Vasanth Nagar
Bangalore
KARNATAKA
560001
India |
| Phone |
9845287827 |
| Fax |
|
| Email |
rudraprasad173@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rudra Prasad M S |
| Designation |
Consultant Orthopaedic and Robotic Joint Replacement Surgery |
| Affiliation |
SPARSH Super Specialty Hospital |
| Address |
Room no 002
Department of Orthopaedics
146 Infantry Road Vasanth Nagar
Bangalore
KARNATAKA
560001
India |
| Phone |
9845287827 |
| Fax |
|
| Email |
rudraprasad173@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Rudra Prasad M S
SPARSH Super Specialty Hospital
146 Infantry Rd Vasanth Nagar Bengaluru
Karnataka 560001
|
|
|
Primary Sponsor
|
| Name |
Dr. Rudra Prasad M S |
| Address |
SPARSH Super Specialty Hospital
146 Infantry Road Vasanth Nagar Bengaluru 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 Rudra Prasad M S |
SPARSH Super Specialty Hospital |
Room no 002
Department of Orthopaedics
146 Infantry Road Vasanth Nagar
Bangalore
KARNATAKA |
9845287827
rudraprasad173@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sparsh Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M799||Soft tissue disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Helysis PLDLA-BTCP |
Interference screw with PLDLA-BTCP material is used for tibial fixation of the graft and will stay permanently in the body after implantation (Duration: Permanent implant) |
| Intervention |
T-Button A |
Peek button-closed 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. Participants with traumatic ACL tears with or without associated meniscus injuries requiring primary ACL reconstruction surgery
2. 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 greater 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 the trial 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
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess functional outcomes of Knee post-surgery within the groups and between the two groups. |
Screening/ Baseline, month 1.5, month 3, month 6, and month 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the clinical symptoms and activity level between the two groups.
2. To assess the failure rate of ACL reconstruction between the two groups.
3. To assess change in quality of life in patients between the two groups.
4. To assess the duration of surgery between the two groups
5. To assess the overall intraoperative handling between the two groups.
6. To assess the safety of the implants |
1. Screening/ Baseline, month 1.5, month 3, month 6 and month 12
2. All visits after surgery including surgery day
3. Screening/ Baseline, month 12
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)
|
11/02/2025 |
| 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) |
Open to Recruitment |
|
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 is a Single Centre, Prospective, Randomized, Open Label Study to Assess Clinical and Functional Outcomes After Anterior Cruciate Ligament (ACL) Reconstruction Procedure Using Suspensory Tibial Fixation and Interference Tibial Fixation |