| CTRI Number |
CTRI/2024/02/062499 [Registered on: 09/02/2024] Trial Registered Prospectively |
| Last Modified On: |
02/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Can semitendinosus alone be used in ACL reconstruction? |
|
Scientific Title of Study
|
A cross sectional study to determine usable semitendinosus tendon length in a cohort of patients undergoing anterior cruciate ligament reconstruction with hamstrings graft
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nirmal Sanjaykumar Rathi |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences,Raipur |
| Address |
D-306,Resident Hostel,AIIMS Campus,Tatibandh,Raipur, Chhattisgarh-492099
Raipur CHHATTISGARH 492099 India |
| Phone |
07387626955 |
| Fax |
|
| Email |
nirmalrathi7@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr.Sandeep Kumar Neema |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences,Raipur |
| Address |
Department of Orthopaedics,
D-block ground floor, All India Institute of Medical Sciences,Tatibandh,Raipur, Chhattisgarh-492099
Raipur CHHATTISGARH 492099 India |
| Phone |
8940162132 |
| Fax |
|
| Email |
drsandeepnema@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Nirmal Sanjaykumar Rathi |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences,Raipur |
| Address |
D-306,Resident Hostel,AIIMS Campus,Tatibandh,Raipur, Chhattisgarh-492099
Raipur CHHATTISGARH 492099 India |
| Phone |
07387626955 |
| Fax |
|
| Email |
nirmalrathi7@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences,Raipur |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences,Raipur |
| Address |
All India Institute of Medical Sciences,Tatibandh,Raipur, Chhattisgarh-492099 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nirmal Sanjaykumar Rathi |
AIIMS Raipur |
Department of Orthopaedics,D-block Ground Floor,All India Institute of Medical Sciences,Tatibandh,Raipur, Chhattisgarh-492099 Raipur CHHATTISGARH |
07387626955
nirmalrathi7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences, Raipur (Chhattisgarh) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
MRI confirmed anterior cruciate ligament tears in adults undergoing ACL reconstruction will be included in the study |
|
| ExclusionCriteria |
| Details |
Patients of knee injury where other graft options are used for ACL Recpnstruction |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| We expect that the usable length and diameter of the quadrupled semitendinosus tendon will be more than 600mm and 8 mm after resection of flat terminal portion and muscle belly and keeping the cross-sectional diameter with circular or oval |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not appliocable |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="48" Sample Size from India="48"
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)
|
13/02/2024 |
| 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="6" 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
|
The anterior cruciate ligament (ACL) is one of a pair of cruciate ligaments (the other being the posterior cruciate ligament) in the human knee.The purpose of the ACL is to resist the motions of anterior tibial translation and internal tibial rotation; this is important to have rotational stability. This function prevents anterior tibial subluxation of the lateral and medial tibiofemoral joints. The ACL has mechanoreceptors that detect changes in direction of movement, position of the knee joint, and changes in acceleration, speed, and tension. A key factor in instability after ACL injuries is having altered neuromuscular function secondary to diminished somatosensory information. For athletes who participate in sports involving cutting, jumping, and rapid deceleration, the knee must be stable in terminal extension.The ACL can be injured or torn in a number of different ways. The most common mechanism is that of a sudden pivoting or cutting maneuver during sporting activity, which is commonly seen in football, basketball and soccer. The ligament can also tear due to work injuries or automobile accidents.At the time of the injury, a “pop†or “snap†can sometimes be felt or heard. The amount of pain experienced at the time of the injury is somewhat variable but can be quite severe. Typically, the person is unable to continue play or activity, and has the impression that a significant injury has occurred. During ACL reconstruction surgery, a graft is used to replace the torn ACL. One option for the graft is to use the hamstring tendons, specifically the semitendinosus and gracilis tendons, which are located at the back of the thigh. These tendons are often selected due to their accessibility, strength, and potential for successful incorporation into the knee joint.The surgical procedure involves harvesting the hamstring tendons, usually through a small incision near the knee. The tendons are then prepared by removing any excess tissue and folded over to create a stronger graft. The graft is then inserted into the knee joint, passing through tunnels drilled in the tibia and femur, to mimic the function of the original ACL. Graft strength is only one of the factors influencing anterior cruciate ligament (ACL) graft choice.However, it has a direct bearing on ultimate stability,which is the goal of ACL.Load to failure (LTF) is the parameter used to compare strenghth of graft.10-mm BPTB graft would be 110% as strong as the native ACL. A two-strand semitendinosus (ST) and two-strand gracilis (Gr) (2ST/2Gr)graft would be 238% as strong as the native ACL.A four-strand ST (4ST) would be 280% as strong as the ACL.Four-strand hamstring autografts are the strongest available grafts,followed by tibialis, QT, and BPTB grafts, with insufficient data to evaluate Tendo Achilles grafts. All have greater strength than the native ACL.Graft strength is only one of many factors contributing to knee stability after ACL reconstruction.grafts retain only about half their initial strength at long-term follow-up. Thus, grafts that are significantly stronger than the native ACL at time zero may indeed be necessary to produce ultimate strengths that are as strong as the ACL initially was.Allografts are increasing rapidly in populari |