Evaluation of full weight bearing results immediately after surgery compared with Partial weight bearing in the first month after surgery in patients with anterior cruciate ligament rupture: A randomized clinical trial
The purpose of this study is to evaluate the results of two treatment methods (full weight bearing immediately after surgery and Partial weight bearing in the first month after surgery) in patients with Anterior Cruciate Ligament (ACL) tear
Design
Double-Blind randomized clinical trial (random block size: 4, via online Random allocation software), includes 84 patients in the two groups experimental and control group and phase 3 study
Settings and conduct
In this double blind randomized clinical trial, patient’s sufferer Anterior Cruciate Ligament (ACL) rupture will be enrolled. This study includes patients referred to our orthopedic academic center (Poursina hospital) who are candidates for ACL reconstructive surgery and they will be divided randomly to two groups of full weight bearing immediately after surgery and Partial weight bearing in the first month after surgery
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Anterior Cruciate Ligament (ACL) rupture defined as +3 Lachman test in physical examination confirmed by Knee MRI as complete rupture
Individuals aged from 18 to 50
Individual consent for participation in the study
Exclusion criteria:
Any history of knee surgery
History of ACL rupture in opposite knee
Any injuries in knee ligaments
Abnormal radiography of the knee. (Including varus above 15 degrees)
Any sign or symptom in hip or ankle.
Intervention groups
Experimental group: full weight bearing immediately after surgery
Control group: Partial weight bearing in the first month after surgery in patients with anterior cruciate ligament rupture
Main outcome variables
time to return to exercise, quality of return to exercise, range of motion, Lachman test (+3 - 0), Knee Injury and Osteoarthritis Outcome Score (KOOS), , Lysholm Score, International Knee Documentation Committee (IKDC), Pain during kneeling, Anterior knee pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110809007274N17
Registration date:2022-02-10, 1400/11/21
Registration timing:registered_while_recruiting
Last update:2022-02-10, 1400/11/21
Update count:0
Registration date
2022-02-10, 1400/11/21
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
Expected recruitment start date
2022-01-25, 1400/11/05
Expected recruitment end date
2022-06-20, 1401/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of full weight bearing results immediately after surgery compared with Partial weight bearing in the first month after surgery in patients with anterior cruciate ligament rupture: A randomized clinical trial
Public title
full weight bearing immediately after surgery and Partial weight bearing in the first month in anterior cruciate ligament rupture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Anterior Cruciate Ligament (ACL) rupture defined as +3 Lachman test in physical examination confirmed by Knee Magnetic resonance imaging (MRI) as complete rupture
Individuals aged from 18 to 50
Individual consent for participation in the study
Exclusion criteria:
Any history of knee surgery
History of Anterior Cruciate Ligament (ACL) rupture in opposite knee
Any injuries in knee ligaments
Abnormal radiography of the knee (including Varus above 15 degrees)
Any sign or symptom in hip or ankle
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
In this study estimated sample size is 84 patients and randomization will be applied using random block design (block size: 4, via online Random allocation software). So, 21 quadruple blocks will be obtained and 42 patients will be in group A and 42 patients in group B. List of patients is kept in orthopedic research center in a sealed envelope and will be read daily after the study begins.
Blinding (investigator's opinion)
Double blinded
Blinding description
In current Double-Blind randomized clinical trial, patients are unaware about when and how to weight bearing. Also, evaluating researcher will be different from the person doing the study intervention. Two orthopedic assistants will be used for this purpose.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Guilan university of medical sciences