| CTRI Number |
CTRI/2024/11/077433 [Registered on: 27/11/2024] Trial Registered Prospectively |
| Last Modified On: |
01/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
"A Study on MRI and Hamstring Autograft Size for Improved Surgical Planning" |
|
Scientific Title of Study
|
Investigating the Magnetic Resonance Imaging Cross-section area that best correlates with intraoperative hamstring auto graft size. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anil Kumar Das |
| Designation |
Junior Resident Academic |
| Affiliation |
Rajendra Institute of Medical Sciences |
| Address |
Department Of Orthopaedics, Rajendra Institute Of Medical Sciences, Ranchi
Ranchi JHARKHAND 834009 India |
| Phone |
09097168290 |
| Fax |
|
| Email |
eni26k@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Govind Kumar Gupta |
| Designation |
Additional Professor |
| Affiliation |
Rajendra Institute of Medical Sciences |
| Address |
Department of Orthopaedics, Rajendra Institute of Medical
Sciences, Bariatu, Ranchi, Jharkhand Rajendra Institute Of Medical
Sciences
Ranchi
JHARKHAND
834009
India
Ranchi JHARKHAND 834009 India |
| Phone |
7979014287 |
| Fax |
|
| Email |
gkgupta1975@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Govind Kumar Gupta |
| Designation |
Additional Professor |
| Affiliation |
Rajendra Institute of Medical Sciences |
| Address |
Department of Orthopaedics, Rajendra Institute of Medical
Sciences, Bariatu, Ranchi, Jharkhand
India
Ranchi JHARKHAND 834009 India |
| Phone |
7979014287 |
| Fax |
|
| Email |
gkgupta1975@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Orthopaedics, Rajendra Institute of Medical
Sciences, Bariatu, Ranchi, Postal Code 834009
Jharkhand
India |
|
|
Primary Sponsor
|
| Name |
Rajendra Institute of Medical Sciences |
| Address |
Department of Orthopaedics, Rajendra Institute of Medical
Sciences, Bariatu, Ranchi, Postal Code 834009
Jharkhand
India |
| 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 Anil Kumar Das |
Rajendra Institute of Medical Sciences |
Department Of Orthopaedics, A2,B1 and C2 Ward, Ground Floor Bariatu. Ranchi JHARKHAND |
09097168290
eni26k@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC,RIMS,Ranchi |
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
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Young Adults (20 – 45 yr).
2. Patients with chronic ACL Injury.
3. Patients with ACL injury associated with Meniscal Injuries.
|
|
| ExclusionCriteria |
| Details |
1. Patients with acutely injured Knee.
2. Patients with history of previous Knee
surgeries.
3. Patients with infection of the Knee.
4. Patients with degenerative joint disease of the
Knee.
5. Patients with multi ligamentous knee instability.
6. Patients with stiff Knee with deformity.
7. Patients with associated metabolic disorders.
8. Patients with associated inflammatory disorders
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary objective of this study is to investigate the feasibility and accuracy of utilizing pre-operative MRI scans to predict the intraoperative hamstring graft size in patients undergoing anterior cruciate ligament (ACL) reconstruction surgery. |
1 Year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To determine the extent of correlation between specific pre-operative MRI measurements and the actual intraoperative hamstring graft size.
2.To develop a predictive model based on the pre-operative MRI data that can estimate the intraoperative hamstring graft size with a high level of accuracy.
|
1 Year |
|
|
Target Sample Size
|
Total Sample Size="41" Sample Size from India="41"
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)
|
01/12/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The primary function of the ACL is to prevent anterior translation of the tibia relative to the femur. Other functions of the ACL include resisting internal rotation of the tibia and varus or valgus stress of the tibia in the presence of collateral ligament injury.Rupture of ACL is one of the most common ligamentous injuries of the knee with an incidence of 68.6 per 100,000 population. The incidence of reconstruction of the anterior cruciate ligament has been reported as high as 75,000–100,000 per year in the India. It is most commonly caused by sports injuries, however in India, it is mainly caused by road traffic accidents. Anterior cruciate ligament (ACL) injury is very frequent, not only in professional athletes but also–increasingly often- in people who practice sports regularly. Conservative treatment usually fails to eliminate recurrent symptoms during the return to activities. Additionally, with subsequent instability episodes, patients may show an accelerated onset of degenerative joint changes and meniscal injuries. ACL reconstruction aims to eliminate symptoms and prevent such degenerative joint changes.ACL reconstruction restores the stability of the knee joint and protects the menisci and joint surfaces from further damage,6and prevents worsening of existing chondral lesions as well as occurrence of newer lesions. Reconstruction of the ACL may also alter the incidence of osteoarthritis in the longer term. Also, ACL does not have the potential to adequately heal by itself when torn, therefore surgical ACL reconstruction is generally the treatment of choice. Large variation in tendon size between individuals makes hamstring graft diameter for anterior cruciate ligament (ACL) reconstruction unpredictable. Inadequate graft diameter may necessitate an alternative source of tissue requiring pre-operative planning. The purpose of this study was to determine whether, magnetic resonance image (MRI) measurements and clinical anthropometric data are predictive of hamstring tendon graft diameter. |