| CTRI Number |
CTRI/2017/03/008098 [Registered on: 15/03/2017] Trial Registered Prospectively |
| Last Modified On: |
28/02/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing two grafts for treatment of knee instability |
|
Scientific Title of Study
|
“A randomized controlled study assessing outcomes after anterior cruciate ligament reconstruction, using quadriceps tendon autograft and hamstrings tendon autograft at the end of one year.†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sandeep kumar nema |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research puducherry 605006 |
| Address |
Department of orthopedicsPMRC Block JIPMER puducherry 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
0413-2276132 |
| Fax |
|
| Email |
drsandeepnema@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep kumar nema |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research puducherry 605006 |
| Address |
Department of orthopedicsPMRC Block JIPMER puducherry 605006
PONDICHERRY
605006
India |
| Phone |
0413-2276132 |
| Fax |
|
| Email |
drsandeepnema@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep kumar nema |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research puducherry 605006 |
| Address |
Department of orthopedicsPMRC Block JIPMER puducherry 605006
PONDICHERRY
605006
India |
| Phone |
0413-2276132 |
| Fax |
|
| Email |
drsandeepnema@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal institute of postgraduate medical education and research pondicherry |
|
|
Primary Sponsor
|
| Name |
Jawaharlal institute of postgraduate medical education and research puducherry |
| Address |
Dr Sandeep kumar nema Assistant Professor of orthopedics PMRC Block JIPMER Puducherry 605006. |
| 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 sandeep kumar nema |
jawaharlal institute of postgraduate medical education and research |
room number 64 department of orthopedics PMRC Block JIPMER
Pondicherry
PONDICHERRY |
0413-2276132
drsandeepnema@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethical committee (human research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Anterior cruciate ligament injury/insuffieciency/tear, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hamstrings group |
Anterior cruciate ligament reconstruction using autologous hamstrings tendons will be done for patients recruited in this group |
| Intervention |
Quadriceps tendon group |
Anterior cruciate ligament reconstruction using autologous quadriceps tendon will be done for patients recruited in this group |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
patients with complete/partial ACL rupture with or without concomitant grade I and Grade II injuries to the collateral ligaments requiring surgery due to instability.
|
|
| ExclusionCriteria |
| Details |
1 Patients presenting with an ACL injury greater than one year will be excluded from the
study.
2 Patients with avulsion fractures will be excluded from the study.
3 Inability to give informed consent for the study.
4 local active or suspected infection, systemic diseases that might influence the study
results.
5 Current or past injuries to the ipsi- or contralateral knee, possibly altering knee function,
including previous ACL rupture.
6 Patients with a concomitant posterior cruciate ligament injury
7 Concomitant articular cartilage lesions larger than 2 cm with a depth of more than 50%of
the cartilage thickness; and meniscal injuries involving more than two-thirds of the meniscus or the need for meniscus repair.
8 Mal-alignment of the lower extremity (greater than 5 mm of mechanical axis deviation as
measured on standing hip-knee-ankle radiographs).
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
measurement of the one leg hop index after quadriceps tendon(QT) autograft and hamstrings tendon autograft for ACLR at the end of one year.
|
one year after operation.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| measurement of the functional outcomes using subjective international knee documentation committee( IKDC) form. |
one year after operation |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
02/04/2017 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not published so far |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, double blind, parallel group, trail comparing the safety and efficacy of quadriceps tendon autograft and Hamstrings tendons autograft for anterior cruciate ligamnent insuffieciency. The study will be conducted at Jawaharlal institute of postgraduate medical education and research puducherry on 60 patients meeting the inclusion and exclusion criteria. The primary outcome measures will be measurement of one leg hop index at the end of one year after the anterior cruciate ligament reconsctrution with either of the grafts. The secondary outcomes will be measurement of international knee documentation committee (IKDC) subjective and objective assessments at the end of one. |