| CTRI Number |
CTRI/2019/02/017375 [Registered on: 01/02/2019] Trial Registered Prospectively |
| Last Modified On: |
31/01/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Arthroscopic Anterior Cruciate Ligament reconstruction by two methods, all inside and outside in method. |
|
Scientific Title of Study
|
Comparison of functional outcome of arthroscopic anterior cruciate ligament reconstruction using all inside technique versus outside in technique – a double blind randomized controlled trial. |
| Trial Acronym |
anterior cruciate ligament reconstruction |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR BISHNU PRASAD PATRO |
| Designation |
ADDITIONAL PROFESSOR AND HEAD OF THE DEPARTMENT |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
ADDITIONAL PROFFESOR AND HEAD OF THE DEPARTMENT,
DEPARTMENT OF ORTHOPEDICS,
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, BHUBANESWAR
ADDITIONAL PROFFESOR AND HEAD OF THE DEPARTMENT,
DEPARTMENT OF ORTHOPEDICS,
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, BHUBANESWAR
Khordha
ORISSA
751019
India |
| Phone |
9437182313 |
| Fax |
9437182313 |
| Email |
bishnucolors@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR BISHNU PRASAD PATRO |
| Designation |
ADDITIONAL PROFESSOR AND HEAD OF THE DEPARTMENT |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
ADDITIONAL PROFFESOR AND HEAD OF THE DEPARTMENT,
DEPARTMENT OF ORTHOPEDICS,
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, BHUBANESWAR
ADDITIONAL PROFFESOR AND HEAD OF THE DEPARTMENT,
DEPARTMENT OF ORTHOPEDICS,
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, BHUBANESWAR
Khordha
ORISSA
751019
India |
| Phone |
9437182313 |
| Fax |
9437182313 |
| Email |
bishnucolors@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PAULSON VARGHESE |
| Designation |
JUNIOR RESIDENT( ACADEMIC) |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES,BHUBANESWAR |
| Address |
DEPARTMENT OF ORTHOPEDICS,
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, BHUBANESWAR
DEPARTMENT OF ORTHOPEDICS,
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, BHUBANESWAR
Khordha
ORISSA
751019
India |
| Phone |
9746189840 |
| Fax |
9746189840 |
| Email |
paulguvera@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES,BHUBANESWAR |
|
|
Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES BHUBANESWAR |
| Address |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES,SIJUA,PATRAPADA BHUBANESWAR |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR PAULSON VARGHESE |
JUNIOR RESIDENT(ACADEMIC)
DEPARTMENT OF ORTHOPEDICS
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, BHUBANESWAR |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR PAULSON VARGHESE |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
SIJUA,PATRAPADA,DUMDUMA PO
BHUBANESWAR
Khordha
ORISSA |
9746189840
9746189840
paulguvera@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ALL INDIA OF MEDICAL SCIENCES,BHUBANESWAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ALL INSIDE TECHNIQUE |
. Arthroscopic ACL reconstruction uses various techniques like all inside technique that depends on the use of adjustable loop only or outside in technique with complete tibial tunnel using adjustable loop and bio screw.
|
| Comparator Agent |
OUTSIDE IN |
. Arthroscopic ACL reconstruction uses various techniques like all inside technique that depends on the use of adjustable loop only or outside in technique with complete tibial tunnel using adjustable loop and bio screw.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 - Patients with symptoms of knee pain or instability who are diagnosed as having ACL tear after clinical examination and confirmed with radiological investigations and diagnostic arthroscopy.
2 - Patients who have tried conservative treatment with hamstring exercises and failed to improve or improved partially
3 - Active, motivated patients aged between 20 to 60 years and belonging to either sex who are involved in heavy physical activities or athletic activities or patients who are unwilling to modify their present active life style
4- Associated with medial or lateral meniscus tear injuries.
5 - Patients who have recovered from the acute inflammatory stage of injury with return of full range of knee motion and decrease in swelling which usually takes 4 to 6 weeks
|
|
| ExclusionCriteria |
| Details |
1- Patients who are not falling in the above age group
2- Patients with associated injuries of lower limb (bony injuries or injuries involving other ligaments) and injury to spine
3- Patients who have radiological evidence of Grade III or IV osteoarthritis knee (Kellegren and Lawrence grading)
4- Patients requiring revision ACL reconstruction.
5- Patients with stiff knee or restricted range of motion
6- Patients having local skin lesion which is not amenable to any intervention
7- Patients who are not fit to undergo surgery from anesthesia point of view
8- Patients who are unwilling to give consent for surgery
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the functional outcome in terms of VAS score and lysholm score following surgery using all inside and outside in technique using endo button and bio screw. |
patients will be evaluated at 2 days,5 days,2 weeks 6 weeks and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the results and outcome of arthroscopic ACL reconstruction using all inside technique using adjustable loop with endobutton and outside in technique using endobutton and bio screw in terms of
1-post operative pain
2-Instability while walking
3- Postoperative complications
|
patients will be evaluated at 2 days,5 days,2 weeks 6 weeks and 3 months |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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 1 |
|
Date of First Enrollment (India)
|
02/02/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
02/02/2019 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT YET PUBLISHED |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
ACL tear represents one of the most common
sports related injury in the young population. Arthroscopic ACL reconstruction
is popular since last 20 years. In last 20 years the commonly method used was
outside in technique. There is evolution of another method since last 7 years
known as all inside technique. But its clinical use was evident since last 2
years. Some features in this technique include closed socket tunnel, dual
suspensory graft fixation, better hold, decreased bone removal and small skin
incision. Due to smaller incision there is less swelling and hematoma
formation, besides it can be done with 4mm incision if an allograft is used for
graft preparation.
Traditional ACL reconstruction techniques involve drilling of a tunnel from the
outer tibial cortex into the proximal tibia and knee joint. Through this tunnel
the ACL graft is inserted and securely fixed into the tibia. This tibial tunnel
is a significant source of pain following ACL surgery as the periosteum over
the tibial cortex is sensitive and a violation of this area is similar to the
pain experienced with a fracture. In literature there are few studies comparing
both the methods in terms of functional outcomes but are not sufficient to
conclude the best technique out of the two. We presume some more studies are
required to validate the superiority of one over the other. Our study aims to
find out the better technique among both in a developing country like India at
a tertiary care hospital. |