(1) Objectives: to compare the therapeutic effects of two different techniques in the treatment of ACL tear (2) Design: Randomized controlled trial. (3) Setting and conduct: Sample size of 154 patients will randomly assign into A) four-strand hamstring auto-graft tendons versus B) quadriceps auto-graft tendons in ACL Reconstruction
(4) Participants: Inclusion criteria: regularly athletic cases with age18-50 years, clinically and radiographically diagnosed as complete ACL tear . Exclusion criteria:any knee surgeries, contralateral ACL tear, other ligament injueries (except medial and lateral menisci, abnormal knee X-ray, symptomatic ankle or knee.
(5) Interventions: ACL Reconstruction usinig A) four-strand hamstring auto-graft tendons versus B) quadriceps auto-graft tendons
(6) Main outcome measures: Primary outcome is ???
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201706107274N13
Registration date:2017-08-08, 1396/05/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-08, 1396/05/17
Registrant information
Name
Mohsen Mardani Kivi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1321 1470
Email address
mardani@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Guilan University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of four-strand hamstring and quadriceps autograft tendons in Arthroscopic Anterior Cruciate Ligament Reconstruction
Public title
Comparison of hamstring versus quadriceps tendons in Arthroscopic Anterior Cruciate Ligament Reconstruction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: regularly athletic cases with age18-50 years, clinically and radiographically diagnosed as complete ACL tear . Exclusion criteria:any knee surgeries, contralateral ACL tear, other ligament injueries (except medial and lateral menisci, abnormal knee X-ray, symptomatic ankle or knee.
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
154
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee, Guilan University of Medical Sciences
Street address
Research vice-chancellor of Guilan university of medical sciences building, Shahid Beheshti blv.
City
Rasht
Postal code
Approval date
2017-06-03, 1396/03/13
Ethics committee reference number
IR.GUMS.REC.1396.80
Health conditions studied
1
Description of health condition studied
anterior cruciate ligament tear
ICD-10 code
S83.5
ICD-10 code description
Sprain and strain involving (anterior)(posterior) cruciate ligament of knee
Primary outcomes
1
Description
KOOS score
Timepoint
3,6 and 12 month after surgery
Method of measurement
KOOS score standard questionnaire
2
Description
IKDC Score
Timepoint
3,6 and 12 month after surgery
Method of measurement
IKDC Score standard questionnaire
3
Description
lysholm Score
Timepoint
3,6 and 12 month after surgery
Method of measurement
lysholm Score standard questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The second group (reconstruction of the anterior cruciate ligament with quadriceps): After creating a 3cm incision in Antromedial site, semitendinosus and gracilis tendons will be separated with a 10mm Stripper from the muscle and four-strand graft will be used to reconstruct the anterior cruciate ligament.
Category
Treatment - Surgery
2
Description
The first group (reconstruction of the anterior cruciate ligament with hamstring): After creating a 3cm incision in Antromedial site, Hamstring tendon will be separated with a 10mm Stripper from the muscle and four-strand graft will be used to reconstruct the anterior cruciate ligament.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasht Poursina Hospital
Full name of responsible person
Mohsen Mardani Kivi MD.
Street address
Rasht,poursina Crossroads, Poursina hospital
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Guilan University of Medical Sciences
Full name of responsible person
shadman nemati MD, Research chancellor of Guilan university of medical science
Street address
Research vice-chancellor of Guilan university of medical sciences building, Shahid Beheshti blv.
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Guilan University of Medical Sciences