| CTRI Number |
CTRI/2024/09/073758 [Registered on: 11/09/2024] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Is Central soft tissue Quadriceps Tendon Graft better than Quadrupled Hamstring Tendon graft in Key Hole ACL Reconstruction Surgery ? |
|
Scientific Title of Study
|
Comparison of Functional Outcome of Central Soft Tissue Quadriceps Tendon Graft versus Quadrupled Hamstring Tendon Graft for Arthroscopic Anterior Cruciate Ligament Reconstruction- A Prospective Randomized Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aswin S |
| Designation |
Postgraduate MS Orthopaedics |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Department of Orthopaedics,
SRM Medical College Hospital and Research Centre,
SRM Institute of Science and Technology,
SRM Nagar,
Potheri,
Kattankulathur,
Chengalpattu
Chennai
TAMIL NADU
603203
India |
| Phone |
8903665533 |
| Fax |
|
| Email |
as1446@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Devi Prasad S |
| Designation |
Professor MS Orthopaedics |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Department of Orthopaedics,
SRM Medical College Hospital and Research Centre,
SRM Institute of Science and Technology,
SRM Nagar,
Potheri,
Kattankulathur,
Chengalpattu
Chennai
TAMIL NADU
603203
India |
| Phone |
9942508444 |
| Fax |
|
| Email |
devipras@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Karthikeyan S |
| Designation |
Assistant Professor MS Orthopaedics |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Department of Orthopaedics,
SRM Medical College Hospital and Research Centre,
SRM Institute of Science and Technology,
SRM Nagar,
Potheri,
Kattankulathur,
Chengalpattu
Chennai
TAMIL NADU
603203
India |
| Phone |
9962855436 |
| Fax |
|
| Email |
karthiks15@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM Medical College Hospital and Research Centre,
SRM Institute of Science and Technology,
SRM Nagar,
Kattankulathur,
Potheri,
Chengalpattu,
Pin code - 603203 ,
India. |
|
|
Primary Sponsor
|
| Name |
Aswin S |
| Address |
Department of Orthopaedics,
SRM Medical College Hospital and Research Centre,
SRM Institute of Science and Technology,
SRM Nagar,
Potheri,
Kattankulathur,
Chengalpattu |
| 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 Aswin S |
SRM Medical College Hospital and Research Centre |
Department of Orthopaedics,
SRM Medical College Hospital and Research Centre,
SRM Institute of Science and Technology,
SRM Nagar,
Potheri,
Kattankulathur,
Chengalpattu
Chennai
TAMIL NADU |
8903665533
as1446@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College Hospital- Students Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S835||Sprain of cruciate ligament of knee, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Central Soft Tissue Quadriceps Tendon graft Group |
Arthroscopic Anterior Cruciate Ligament Reconstruction with Central Soft Tissue Quadriceps Tendon Graft in patients with Anterior Cruciate Ligament Tear. |
| Comparator Agent |
Quadrupled Hamstring Tendon Graft Group |
Arthroscopic Anterior Cruciate Ligament Reconstruction with Quadrupled Hamstring Tendon Graft in patients with Anterior Cruciate Ligament Tear |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient with Isolated Anterior cruciate ligament tear
|
|
| ExclusionCriteria |
| Details |
1. Multi-ligamentous injury
2. Revision Anterior Cruciate Ligament Reconstruction surgery
3. Associated Ipsilateral Limb Fractures where Anterior Cruciate Ligament Reconstruction planned
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare Functional outcomes in ACL Reconstruction using, 1. Lysholm knee score
2. IKDC-SKF( International Knee Documentation Committee - Subjective Knee Evaluation Form) SCORE
3.Tegner activity scale
4. ACL-RSI ( Anterior Cruciate Ligament-Return to Sport after Injury) Score
5. Passive Knee Range of Movements
|
Post Surgical intervention followed up at 1st month, 3rd month, 5th month, Return to preinjury level ( at which specified month) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess these factors post operatively
1. VAS Score
2. Thigh Circumference
3. Active Knee range of movements to assess if any Extensor Lag ( measure in degrees) is present |
Post Surgical intervention followed up at 1st month, 3rd month, 5th month, Return to preinjury level ( at which specified month) |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
Final Enrollment numbers achieved (Total)= "68"
Final Enrollment numbers achieved (India)="68" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
17/09/2024 |
| Date of Study Completion (India) |
26/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Consent will be obtained from eligible participants of this study based on the above mentioned inclusion and exclusion criteria. Demographic information, anthropometric measurements will be collected from all participants. Blood investigations will be done for all participants. Intra operative obtained graft measurements will be recorded. Post operatively all patients of both the group will be following the standardized same ACL protocol physiotherapy . Post operatively patient of the both groups will be followed up at specified interval mentioned above and functional outcome measurements will be recorded. |