Randomized clinical trial of the result of transtibial Trans-Fix and transportal Trans-Fix femoral fixation surgery methods in anterior cruciate ligament reconstruction
The use of Transfix technique is well accepted when performing anterior cruciate ligament reconstruction. We intended to compare the clinical results of transtibial Transfix ACL reconstruction with transportal TransFix method. :One hundred and eighty active young patients with anterior cruciate ligament injury will randomize into either transtibial TransFix (Arthrex, Naples, FL, USA) or transportal TransFix femoral fixation. patients with infection, previous surgery, age over 40 years old, bilateral injuries and who had other ligament injuries that need reconstruction. After one year patients will be clinically evaluated for results using history and physical examination. For objective measurements Rolimeter will be used to evaluate the laxity. Positions of tunnels will be also evaluated in postoperative AP radiography using Sommer technique. We use Tagner activity level score and lysholm scaling score to evaluate the clinical results. At the end results will be analyzed using statistical methods
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201102145276N2
Registration date:2011-05-17, 1390/02/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-05-17, 1390/02/27
Registrant information
Name
Fardin Mirzatolooei
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 1337 3606
Email address
fm.tolooei@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
investigator
Expected recruitment start date
2007-12-31, 1386/10/10
Expected recruitment end date
2009-11-22, 1388/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized clinical trial of the result of transtibial Trans-Fix and transportal Trans-Fix femoral fixation surgery methods in anterior cruciate ligament reconstruction
Public title
Comparison between two different surgical treatment methods in anterior cruciate ligament reconstruction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Symptomatic young active patients with ACL tear
Exclusion criteria:
Patients with infection; previous surgery; age over 40 years old; bilateral injuries and concomitant ligamentous injuries needs surgery.
Age
From 18 years old to 40 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
223
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Orthopedic Ward Research Commitee
Street address
Orthopedic Ward Office
City
Urmia
Postal code
Approval date
2007-12-17, 1386/09/26
Ethics committee reference number
1
Health conditions studied
1
Description of health condition studied
Anterior cruciate ligament surgery
ICD-10 code
S83.5
ICD-10 code description
Sprain and strain involving (anterior)(posterior) cruciate ligament of knee
Primary outcomes
1
Description
Clinical results of anterior cruciate reconstruction
Timepoint
Before and one year after intervention
Method of measurement
Lysholm score
2
Description
Level of sport activity
Timepoint
Before and one year after intervention
Method of measurement
Tagner activity level score
3
Description
Ligament laxity
Timepoint
Before and one year after intervention
Method of measurement
Rolimeter
Secondary outcomes
1
Description
Complications of surgery
Timepoint
During operation and also one year later
Method of measurement
Registration of complications in operation chart and opd charts
Intervention groups
1
Description
Control group: Transtibial method, this is the current method through which every surgeon reconstruct anterior cruciate ligament. In this method femoral tunnel reconstruct through tibial tunnel
Category
Treatment - Surgery
2
Description
Intervention group: Transportal method; This is the new method we want to know its efficacy comparing to the transtibial method. In this method femoral tunnel is created through inferomedial portal
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeini hospital of Urmia University of Medical Sciences