| CTRI Number |
CTRI/2024/01/060991 [Registered on: 01/01/2024] Trial Registered Prospectively |
| Last Modified On: |
28/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Post operative evaluation by clinically and radiologically in cases of primary Anterior Cruciate Ligament repair done by anchor fixation |
|
Scientific Title of Study
|
Evaluation of clinico radiological outcomes following arthroscopic primary anterior cruciate ligament repair using anchor fixation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR TUFAN MANDAL |
| Designation |
DOCTOR(POST GRADUATE RESIDENT) |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room 601,6th floor ,Department of Orthopaedics, New Ortho block, Maulana Azad Medical College
New Delhi
DELHI
110002
India |
| Phone |
8250777487 |
| Fax |
|
| Email |
tufanmandal7249@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinod Kumar |
| Designation |
Director Professor and Head of Department |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room 601,6th floor ,Department of Orthopaedics, New Ortho block, Maulana Azad Medical College
New Delhi
DELHI
110002
India |
| Phone |
8250777487 |
| Fax |
|
| Email |
drvk706@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR TUFAN MANDAL |
| Designation |
DOCTOR(POST GRADUATE RESIDENT) |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room 601,6th floor ,Department of Orthopaedics, New Ortho block, Maulana Azad Medical College
New Delhi
DELHI
110002
India |
| Phone |
8250777487 |
| Fax |
|
| Email |
tufanmandal7249@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and Lok Nayak Hospital |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College and associated Lok Nayak Hospital,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 |
| Dr TUFAN MANDAL |
Maulana Aazad Medical College |
Room no 601, Department of Orthopaedics , Maulana Azad Medical College and associated Lok Nayak Hospital HOSPITAL,NEW DELHI 110002
New Delhi
DELHI |
8250777487
tufanmandal7249@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 |
Arthroscopic primary Anterior Cruciate Ligament repair using anchor fixation in a case of acute ACL injury |
After preparation, tourniquet is inflated and standard anterolateral (AL) and anteromedial (AM)portals are made. A diagnostic arthroscopy is performed to confirm the diagnosis of Anterior
Cruciate Ligament tear and associated meniscal tear or chondral inury. Careful probing of the stump is carried out to confirm a femoral-sided avulsion and quality of the tissue. Decision to
perform a primary repair is made if the tissue quality is good and femoral avulsion is present.Soft tissue around the femoral footprint is cleared using a shaver and 3 to 4 holes are created with a microfracture awl to potentiate healing of the Anterior Cruciate Ligament stump. A malleable passport cannula was placed in the anteromedial portal to facilitate suture passage and ligament repair. The stump is sutured from distal to proximal in a non locking Krackrow technique with no 2 Fiberwire suture using a suture passer. A minimum of 2-3 passes are taken
through the Anterior Cruciate Ligament stump with each limb of the suture, to hold the tissue firmly and traction is checked on the suture. The two ends of the suture are then retrieved out through Anteromedial portal. The femoral inserion point is marked and entry made with a awl to
the depth of 20-23mm. Two ends of the fiberwire are loaded into the eyelet of a 4.75mm anchor. The driver is introduced through the anteromedial portal and inserted into the socket by tapping
and then screwing it while maintaining adequate tension on the suture limbs. Firm fixation of the stump is confirmed by probing. The knee is extended to confirm that there is no impingement.
Post operatively study will be done for 6 months of total duration |
| Comparator Agent |
NIL |
NIL |
|
|
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 anterior cruciate ligament tear of duration less than 6 weeks
2.Anterior cruciate ligament tear occurring from femoral insertion site |
|
| ExclusionCriteria |
| Details |
1.Revision Anterior Cruciate ligament repair or reconstruction surgery
2.Patients having pre-existing degenerative changes in knee
3.Patients with other ligament injuries requiring operative repair or reconstruction
4.Patient with history of previous knee surgery
5.Bony Anterior Cruciate Ligament avulsion injuries
6. Poor quality of the remnant ligament |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical evaluation for the final outcomes of the intervention using the following scores-
1. IKDC score (International knee documentation committee score)
2.Lysholm’s score
3.Tegner activity scale.
4. KOOS (knee injury and osteoarthritis outcome score)
Mainly to see clinically the post operative laxity of knee, improvement of daily living activity ,return to pre injury sports activity |
Outcomes will be assessed at
1. Immediate post operative period
2. 3 months post operatively
3. 6 months post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
MRI to see
1. Healing of Anterior Cruciate Ligament 2. Geometry of Anterior
Cruciate Ligament ligament fibers & any other associated finding
3. Check for possible post-operative complications like re-tear. |
6 month post operative period |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
08/01/2024 |
| 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 Yet Recruiting |
| 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
|
Anterior Cruciate Ligament(ACL) injury is very common problem of the knee especially in athletes and a disabling condition common etiology for knee instability and dysfunction. Although ACL reconstruction gives predictable and good results with various objective and subjective score but has a lot of problem like morbidity in the donor site ,failure of graft, mismatch between footprint and importantly lack of proprioception.Primary Arthroscopic Cruciate Ligament repair have the following advantages of being less invasive ,avoids graft site morbidity, retain native ACL anatomy , collagen orientation, retain of proprioceptive function.Also when Anterior Cruciate Ligament is primarily repaired there is minimal removal of bone and can be easily converted to a reconstruction if primary ACL repair happens to fail in future. |