| CTRI Number |
CTRI/2020/06/025547 [Registered on: 02/06/2020] Trial Registered Prospectively |
| Last Modified On: |
01/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical-radiological outcomes of arthroscopic Anterior Cruciate Ligament reconstruction by single tibial and double femoral socket technique using muscle graft(Semitendinosus) |
|
Scientific Title of Study
|
Clinico-radiological outcomes of arthroscopic All Inside Anterior Cruciate Ligament reconstruction by single tibial and double femoral socket technique using autogenous Semitendinosus graft |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shashank Verma |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College, New Delhi |
| Address |
Department Of Orthopaedic Surgery, Maulana Azad Medical College, New Delhi 110002
Central
DELHI
110002
India |
| Phone |
7900623405 |
| Fax |
|
| Email |
verma.shashank15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinod Kumar |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College, New Delhi |
| Address |
Department Of Orthopaedic Surgery, Maulana Azad Medical College, New Delhi 110002
Central
DELHI
110002
India |
| Phone |
9968604321 |
| Fax |
|
| Email |
drvk706@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shashank Verma |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College, New Delhi |
| Address |
Department Of Orthopaedic Surgery, Maulana Azad Medical College, New Delhi 110002
Central
DELHI
110002
India |
| Phone |
7900623405 |
| Fax |
|
| Email |
verma.shashank15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi-110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Department Of Orthopaedic Surgery, Maulana Azad Medical College, New Delhi 110002 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Shashank Verma |
Maulana Azad Medical College |
Department Of Orthopaedic Surgery,
Central
DELHI |
7900623405
verma.shashank15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Clinico-radiological outcomes of arthroscopic All Inside Anterior Cruciate Ligament reconstruction using single tibial and double femoral socket technique using autogenous Semitendinosus graft |
Reconstruction of ACL Using Autogenous Semitendinosus Graft By All Inside Technique using single tibial and double femoral socket |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Clinico-radiologically diagnosed symptomatic cases of complete ACL tear with
unstable knee.
2. Age between 18 and 60 yrs.
|
|
| ExclusionCriteria |
| Details |
1. Patients having pre-existing degenerative changes in the knee.
2. Poorly motivated patients.
3. Patients with other ligament injuries requiring operative repair or reconstruction.
4. Patients with history of previous knee surgeries.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.IKDC score and clinical evaluation
2.Lysholm’s score,
3.Tegner score,
4.KOOS score |
Clinical evaluation will be done at 6 weeks, 3 months post operatively. Following things will be evaluated
1. IKDC score
2. Lysholm’s score
3. Tegner score
4. KOOS
Finally at 6 months post operatively patient is assessed by
1. IKDC score
2. Lysholm’sscore
3. Tegner score
4. KOOS
5. Clinical Examination
a) Anterior drawer test
b) Lachman’s test
c) Pivot shift test
6. KT-1000 study
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. X-Rays
2. CT-scan
3. MRI |
a)X-ray – AP, Lateral view on first postoperative day
b)CT-Scan evaluation will be done on post-operative day 3 and at 6 month
c)MRI will be done at 6 months. |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
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
|
N/A |
|
Date of First Enrollment (India)
|
03/06/2020 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a prospective interventional study evaluating Clinico-radiological outcomes of arthroscopic all inside anterior
cruciate ligament reconstruction by single tibial and double femoral socket
technique using autogenous
semitendinosus graft. |