| CTRI Number |
CTRI/2020/03/023928 [Registered on: 12/03/2020] Trial Registered Prospectively |
| Last Modified On: |
08/02/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of outcome of all inside anterior cruciate ligament reconstruction using semitendinosus autograft with and without augmentation, A prospective randomized control trial.†|
|
Scientific Title of Study
|
“Comparison of outcome of anterior cruciate ligament reconstruction using hamstring autograft with and without augmentation, A prospective randomized control trial.†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SIDDHARTH JAIN |
| Designation |
FELLOW ARTHROSCOPY |
| Affiliation |
AIIMS , NEW DELHI |
| Address |
DEPARTMENT OF ORTHOPEDICS
AIIMS ,NEW DWLHI
SIDDHARTH JAIN
320/2
MASJID MOTH , SOUTH EX 2
South West
DELHI
110023
India |
| Phone |
01126593341 |
| Fax |
|
| Email |
dr.sidrjain@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR HL NAG |
| Designation |
PROFESSOR AND HEAD OF UNIT |
| Affiliation |
AIIMS , NEW DELHI |
| Address |
DEPARTMENT OF ORTHOPEDICS
AIIMS ,NEW DELHI
DEPARTMENT OF ORTHOPEDICS
AIIMS ,NEW DELHI
East
DELHI
110023
India |
| Phone |
01126593341 |
| Fax |
|
| Email |
hlnag2003@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
SIDDHARTH JAIN |
| Designation |
FELLOW ARTHROSCOPY |
| Affiliation |
AIIMS , NEW DELHI |
| Address |
DEPARTMENT OF ORTHOPEDICS
AIIMS ,NEW DWLHI
SIDDHARTH JAIN
320/2
MASJID MOTH , SOUTH EX 2
South West
DELHI
110023
India |
| Phone |
01126593341 |
| Fax |
|
| Email |
dr.sidrjain@gmail.com |
|
|
Source of Monetary or Material Support
|
| all india institute of mrdical science, NEW DELHI , GOVERNMENT organization |
|
|
Primary Sponsor
|
| Name |
AIIMS NEW DELHI |
| Address |
ANSARI NAGAR 110023 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| AIIMS a government organization |
ANSARI NAGAR 110023 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR SIDDHARTH JAIN |
All India Institute of MedicalScience NEW DELHI |
DEPARTMENT OF ORTHOPEDICS ALL NIDIA INSTITUTE OF MEDICAL SCIENCE ANSARI NAGAR NEW DELHI
East
DELHI |
8989097791
dr.sidrjain@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS , NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M235||Chronic instability of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
All inside anterior cruciate ligament reconstruction using semitendinosus autograft with augmentation. |
Standard and described surgical procedure will be followed for anterior cruiciate ligament reconstruction reconstruction using semitendinosis autograft.Graft will be augmented by using suture tap at the time of prepration. |
| Comparator Agent |
All inside anterior cruciate ligament reconstruction using semitendinosus autograft without augmentation |
Standard and described surgical procedure will be followed for anterior cruiciate ligament reconstruction reconstruction using semitendinosis autograft.Graft will not be augmented by anything at the time of prepration. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA:
a) Isolated complete ACL tear
b) ACL deficient Patients having symptom of instability or giving way of the involved knee.
c) Patient age 16-40 year
d) No radiological arthritic changes in affected knee.
e) Patient willing to participate in study.
|
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA-
a) ACL injury associated with other collateral ligament and posterior cruciate ligament injury.
b) Asymptomatic ACL deficient patients
c) Age less than 16 year or more than 40 year.
d) Radiological arthritic changes in affected knee.
e) Patient refused to participate in study
f) Any prior surgery in ipsilateral knee.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Pain ( visual analogue scale)
• Lysholm functional knee score
• Tegner activity scale
• KT 1000 arthrometer laxity measurements
• Subjective examination {Lachmen test, Anterior drawer test, Pivot shift test}
|
SIX MONTHS AFTER THE SURGERY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PROTECTIVE EFFECT OF AUGMENTATION |
Post operatively patient will be followed up at 2, 4 and 6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
18/03/2020 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
STUDY NOT YET STARTED |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Methodology-
We will first clinically assess the patient with
chronic ACL tear for signs (subjective tests) and symptoms of ACL injury. All
the demographic information of the patient like age, sex, occupation, side of
affected limb, mode of injury, injury operation interval involvement in sports
activities will be collected. Patient will have to get preanesthetic clearance.
Patient will be evaluated for Visual analogue score for pain, Lysholm
functional knee score, Tegner activity scale, KT1000 Laxity measurement and
subjective tests for knee laxity and results will be recorded. On the background of diagnosis and symptoms,
patient fulfilling the above mentioned criteria will be allocated in two group
after proper randomization and treated accordingly. Post operatively patient will be followed up
at 2, 4 and 6 months. In follow-up of the patient will be again evaluated for
Visual analogue score for pain, Lysholm functional knee score, Tegner activity
scale KT1000 Laxity measurement and subjective tests
for knee laxity and results will be recorded.
|