This prospective, randomized study is designed to compare the impact of tourniquet release timing on plating of acute extraarticular tibia fracture. Inclusion criteria include age over 18 years and less than 55 years, surgery within the first week after fracture, closed and extraarticular tibia fractures, knee range of motion of more than 135 degrees and exclusion criteria consist of tourniquet time greater than 90 minutes; need for re-operation; patient's reluctance to cooperate in any of stage of the study; and patient’s death. The study will be performed on 40 patients. Convenience sampling will be performed, and the participants will later be randomly allocated into two groups A and B (n=20 per group). Group A includes patients with tourniquet release during surgery and hemostasis before wound closure; Group B consists of patients with tourniquet deflation after wound closure and compression bandage. The data needed will be collected through interviews and observation, and studying patients' files. Range of knee motion in all patients before surgery and 24 hours and 14 days after surgery will be calculated with a standard 30 cm goniometer. Status of wound healing in all patients will be assessed 24 hours and 14 days after operation using the REEDA scale. Their pain will be assessed via visual analogue scale before surgery, 24 hours and fourteen days after operation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015092824252N1
Registration date:2016-05-20, 1395/02/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-20, 1395/02/31
Registrant information
Name
Maryam Khodabakhshi
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3247 3655
Email address
horyms@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Birjand University of Medical Sciences
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of timing of tourniquet release on knee range of motion of patients with plating of tibia fractures: a randomized controlled trial
Public title
Effects of the timing of tourniquet release in orthopedic surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age over 18 years and less than 55 years; doing surgery within the first week after fracture; closed and extraarticular tibia fracture; absence of another fracture in any of the limbs; absence of chest, head or abdomen trauma; absence of vascular and nerve damage, the compartment syndrome and a history of previous surgery on the lower limbs; absence of clotting problems, peripheral vascular disease, peripheral neuropathy and pre-operative DVT limb; non-use of steroidal and non-steroidal anti-inflammatory drugs, anticoagulation, chemotherapy, smoking and narcotics; systolic blood pressure less than 20 mm Hg; body mass index less than 30; knee range of motion of more than 135 degrees
Exclusion criteria: Tourniquet time greater than 90 minutes; need for re-operation; patient’s reluctance to cooperate in any stage of the study; patient’s death
Age
From 18 years old to 55 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Through block randomization, blocks of individuals are selected, and treatment protocol is randomly allocated to them.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Ayatollah Ghaffari Street
City
Birjand
Postal code
9717853577
Approval date
2016-01-11, 1394/10/21
Ethics committee reference number
RECIr.bums.1394.84
Health conditions studied
1
Description of health condition studied
Fracture
ICD-10 code
S82.1
ICD-10 code description
Fracture of upper end of tibia
2
Description of health condition studied
Fracture
ICD-10 code
S82.2
ICD-10 code description
Fracture of shaft of tibia
3
Description of health condition studied
Fracture
ICD-10 code
S82.3
ICD-10 code description
Fracture of lower end of tibia
Primary outcomes
1
Description
Knee Range of Motion
Timepoint
Before surgery, 24 hours and 14 days after surgery
Method of measurement
Goniometer
2
Description
wound healing
Timepoint
preoperatively, 24 hours and 14 days after operation
Method of measurement
REEDA scale
Secondary outcomes
1
Description
pain
Timepoint
Before surgery, 24 hours and 14 days after surgery
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
Intervention group 1: Cuff of tourniquet will be applied on the most muscular part of the femur before surgery prep. The tourniquet used involves the MICROBACE pneumatic tourniquet system with the length of 75 cm and width of 15 cm, which will be applied between the skin and cuff over three layers of cast padding.
After raising limb for 3 minutes and draining the blood, a pressure of 150 mm Hg higher than systolic blood pressure will be applied. Upon fracture reduction and fixation with plat and screws, tourniquet will be opened during surgery and before closing the wound.
Category
Treatment - Surgery
2
Description
Cuff of tourniquet will be applied on the most muscular part of the femur before surgery prep. The tourniquet used involves the MICROBACE pneumatic tourniquet system with the length of 75 cm and width of 15 cm, which will be applied between the skin and cuff over three layers of cast padding. After raising limb for 3 minutes and draining the blood, a pressure of 150 mm Hg higher than systolic blood pressure will be applied. Upon fracture reduction and fixation with plat and screws, the skin and other anatomical layers will be stitched and tourniquet will be opened after closing the wound and applying compression bandage.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Maryam Khodabakhsh, Surgical Technologist, Master Student in Nursing Education
Street address
Imam Reza Hospital, Ayatollah Taleghani Street
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Birjand University of Medical Sciences
Full name of responsible person
Gholamreza Sharifzadeh
Street address
Birjand University of Medical Sciences؛ Ayatollah Ghaffari Stree
City
Birjand
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 of Birjand University of Medical Sciences