| CTRI Number |
CTRI/2014/10/005090 [Registered on: 13/10/2014] Trial Registered Retrospectively |
| Last Modified On: |
18/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of soft tissue graft with intact bony attachment versus free graft (with no bony attachment) for treatment of knee ligament (anterior cruciate) injury |
|
Scientific Title of Study
|
Comparison of ACL reconstruction with free quadrupled hamstring graft versus graft with preserved insertions: A Prospective, Randomized, Double blind Clinical Trial |
| Trial Acronym |
ACLR |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ravi Gupta |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital, Sector 32 Chandigarh |
| Address |
Department of Orthopaedics,
Government Medical College and Hospital, Sector 32 Chandigarh
Department of Orthopaedics Government Medical College and Hospital, Sector 32 Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121592 |
| Fax |
01722609360 |
| Email |
ravikgupta2000@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ravi Gupta |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital, Sector 32 Chandigarh |
| Address |
Department of Orthopaedics,
Government Medical College and Hospital, Sector 32 Chandigarh
Department of Orthopaedics Government Medical College and Hospital, Sector 32 Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121592 |
| Fax |
01722609360 |
| Email |
ravikgupta2000@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Ravi Gupta |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital, Sector 32 Chandigarh |
| Address |
Department of Orthopaedics,
Government Medical College and Hospital, Sector 32 Chandigarh
Department of Orthopaedics Government Medical College and Hospital, Sector 32 Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121592 |
| Fax |
01722609360 |
| Email |
ravikgupta2000@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research New Delhi India |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
Ansari Nagar, New Delhi -110029 |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Ravi Gupta |
Department of Orthopaedics, Block D, Level III |
Government Medical College and Hospital, Sector 32 Chandigarh
Chandigarh
CHANDIGARH |
9646121592
01722609360
ravikgupta2000@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Medical College and Hospital Sector 32 Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S835||Sprain of cruciate ligament of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparison of KT 1000 outcome, proprioreception and the knee score amongst both the arms |
At each follow up the assessment will be done in each patient with KT 1000, tests of proprireception and the Cincinnati knee score |
| Intervention |
Free Hamstring graft after severing its insertion from the tibial attachement |
25 patients who will undergo ACL reconstruction by hamstrings tendon free autograft with the standard surgical technique |
| Intervention |
Hamstring tendon graft with preserved insertions to the proximal tibia |
25 patients who will undergo ACL reconstruction by a technique using hamstrings tendon autograft with preserved insertions
Surgical Technique:
Through a curvilinear incision semitendinosus and gracilis tendons are harvested with an open tendon harvestor with the tibial insertions of the tendons left intact. The proximal free ends of the tendons are sutured together by wrapping the broader aponeurosis of semitendinosus around the gracilis tendon using Ethibond No. 5 suture. The tendons are looped around an Ethibond suture thus creating a quadrupled graft. The graft is sized. The femoral point of entry is marked with a bone awl which is identified at the junction of the lateral condylar ridge and the bifurcate ridge. A guide pin is introduced into the femur. A 4.5 mm canulated drill bit is used to create a tunnel in femur. The length of the tunnel is measured with depth gauze. The reaming of the tunnel is done with a femoral reamer corresponding to the size of the quadrupled tendon. The no 5 ethibone is passed into the tunnel and the loop is left inside the joint. Placing an ACL tibial guide through the anteromedial portal into the posteromedial aspect of ACL’s footprint, the tibial tunnel is angled from a medial-to-lateral direction and posteriorly in the sagittal plane so that the graft does not impinge on the intercondylar roof in full extension. The angle of the tibial guide usually is kept at about 50 degree; however, the angle can be altered if the length of the harvested graft is small. A tibial reamer with a diameter equivalent to the size of the quadrupled graft is used to drill the tunnel. A grasper is used to retrieve the loop of the ethibone no 5 from the tibial tunnel which was already placed in the femoral tunnel and was left in the joint. The length of the tibial tunnel and the intraarticular part of the proposed graft is measured with a depth gauge which is added to the already measured length of the femoral tunnel to know the exact length of the both the tunnels plus the intrarticular path of the graft. An endobutton is used to pull the quadrupled graft into the joint and the length of the loop of the endobutton is decided so that at least 15 mm of the graft remains inside the femoral tunnel. The free end of the graft is pulled to maximal stretch and the joint is moved through full range of motion at least 20 times to remove any kinks in the graft. The tightness of the ACL graft is checked arthroscopically with a probe. With maximal stretch on the free end of the graft, it id sutured to the preserved end of the graft with a number 5 ethibond.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
The proposed study will be a prospective study conducted on 50 patients assessed before surgery and followed-up after surgery for at least 1 year. Various exclusion criteria taken into account will be:
•
Group I: 25 patients who will undergo ACL reconstruction by hamstrings tendon free autograft.
Group II: 25 patients who will undergo ACL reconstruction by a technique using hamstrings tendon autograft with preserved insertions
A thorough clinical examination of both the knee joints will be done preoperatively that will include a detailed history, clinical examination and recording of the Cincinnati score21. X ray and MRI of the affected knee will be done in all the cases. Preoperative values of the various tests of proprioception will be recorded in both the affected and the normal knee.
A Written and informed consent shall be taken from all the patients undergoing surgery. As it is a double blind trail, both the patient and the observer would not know about allocation of the patient in each group. 50 sealed envelops will be prepared containing the name of the surgical technique with 25 envelops belonging to each group. Allocation of the patient in each group will be made by picking up a sealed envelop by the patients after their consent. The requisite surgical technique will be performed as per the allocation envelop on all the patients by the same surgeon. After the surgery a code will be given to the patient, the details of which will not be disclosed to the assessor during the follow up visits.
After the surgery, all the patients will undertake an intensive and same rehabilitating and exercise programme for at least 6 months. The patients will be regularly followed up and evaluated at 3 months, 6 months and 1 year post surgery, on the basis of the clinical tests, arthropometric test and evaluation with Cincinnati Knee Rating System.
|
|
| ExclusionCriteria |
| Details |
Pregnancy
• Multiple ligament injuries
• Generalized ligament laxity
• Previous surgery on the affected knee
• Injury/ Surgery of the contra-lateral limb.
• History of chronic disease such as Neurological / Metabolic disease i.e. polio/diabetes mellitus etc.
• Stiff knee
• Patients with any inflammatory disorders of the knee like osteoarthritis/ rheumatoid arthritis etc.
• Patients with less than 3 weeks of duration after injury or with signs of inflammation whichever is later.
• Younger patients with open epiphyses.
These 50 patients will be randomly selected and divided into two groups depending upon the technique of ACL reconstruction. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To determine the mechanical differences in the reconstructed anterior cruciate ligament with free hamstring graft and the graft with preserved insertions.
2. To determine the proprioceptive differences in the reconstructed anterior cruciate ligament with free hamstring graft and the graft with preserved insertions.
|
Follow up every month and final follow up at one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the long term clinical success of the reconstructed anterior cruciate ligament with free hamstring graft and the graft with preserved insertions.
|
At the end of one year |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/04/2012 |
| Date of Study Completion (India) |
30/04/2014 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Anterior cruciate ligament injury is a common injury seen in young adults resulting in ACL deficient knee. The natural course of an untreated ACL deficient knee results in progressive deterioration of the function of the knee joint and progressive meniscal and chondral damage ultimately leading to degenerative disease of the knee joint. The most accepted treatment of an ACL deficient knee is reconstruction of anterior cruciate ligament arthroscopically by using either a free bone patellar tendon bone graft (BPTB) or a free quadrupled hamstring graft (semitendinosus and gracilis). The use of free grafts requires fixation of both the ends of the graft in femoral and tibial tunnels by using mechanical fixation devices like screws, staples, endobuttons etc. There have been concerns regarding the use of free grafts in terms of loss of the proprioceptive sensations provided by the normal anterior cruciate ligament. We have been using a new surgical technique in our institution where the quadrupled hamstring graft is being used without severing the insertions of the hamstring tendons. Since the insertions of the hamstring tendons at the tibial end are nor severed, the new technique does not require a fixation device to be used on the tibial end of the graft thus resulting in the reduced cost of the surgery. In addition, we hypothesize that preserving the insertions of the hamstring tendons may be beneficial to the patient in terms of providing a better proprioceptive sensation to the knee joint due to the function of neural receptors contained in the ends of the tendons/ aproneurosis. The preliminary results of the technique had been encouraging and have already been published. The present study is proposed to know the mechanical and proprioceptive differences between the traditional technique of using free graft and the new technique of the graft with preserved insertions. |