Comparing of posteromedial versus anteromedial approaches in surgery of extra-articular distal tibia fractures
Design
Patients were diagnosed with extra-articular(close or open) tibial fractures after hospitalization and skin preparation with a posteromedial or anteromedial approach, they were randomly selected. The age and sex of the patient and the contact number were entered into the questionnaire. Subsequent illnesses with a history of drug use, as well as, Fractal typing according to the AO classification, typing soft tissue status were determined by two professors separately and recorded in the questionnaire
Settings and conduct
Patients diagnosed with open-ended or closed-bed tibial distal fracture in Taleghani Hospital of Tehran entered the study.The two intervention groups undergo surgery and the surgical results are compared.
Participants/Inclusion and exclusion criteria
inclusion criteria:
extra-articular distal tibia fractures, Age: 16 -75 years old
exclusion criteria:
1) connective tissue disease
2) Peripheral neurovascular disease
3) Uncontrol D.M
4) Previous scar in the ankle and distal tibia,
5) Previous surgery and fractures in the ankle and distal tibia Previous scar
6) Corticosteroids MTX & Chemotherapeutic drugs
7) Intraarticular fractures
8) Pathology fractures
9) Vascular damage
10) Compartment syndrome
1) superficial skin infection
2) deep infection
3) superficial skin necrosis
4) deep skin necrosis and plate exposure
and needs skin graft or flap
5) wound dehiscence
6) incisional injury to the neurovascular bundle
7) non union
8) delay union
9) malunion
10) mal alinment
11) internal fixation loosening
12) skin sense examination
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180306038971N3
Registration date:2020-12-17, 1399/09/27
Registration timing:retrospective
Last update:2020-12-17, 1399/09/27
Update count:0
Registration date
2020-12-17, 1399/09/27
Registrant information
Name
Mohammad Ali Okhovatpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 2222
Email address
okhovatpour@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
2018-09-23, 1397/07/01
Actual recruitment end date
2019-09-23, 1398/07/01
Trial completion date
2019-09-23, 1398/07/01
Scientific title
Comparing of posteromedial approach versus anteromedial approach in surgery of extra-articular distal tibia fractures
Public title
Comparing postero-medial approach versus antero-medial approach in surgery of extra articular distal tibia fractures in Taleghani hospital_Tehran
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
extra articular distal tibia fractures
Age : 16 -75 years old
Exclusion criteria:
Intra articular fractures
Patologic fractures
Vascular damage
Uncontrol Diabetes mellitus
Corticosteroids drugs
Previous surgery and fractures in this area
Previous scar
Peripheral neurovascular disease
connective tissue disease
Compartment syndrome
chemotherapy
Age
From 16 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
32
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization for 2 intervention groups. The randomization method will be done using software, 20 random numbers for each intervention group.
The researcher can not play a role in predicting the treatment of the disease and choosing the type of treatment. the random sequence will generate by software. Group 1: 20 Cases and Group 2: 20 cases.
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
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Research Deputy,medical school, Arabi Ave, , Velenjak , Tehran
City
Tehran
Province
Tehran
Postal code
1985717413
Approval date
2017-09-04, 1396/06/13
Ethics committee reference number
IR.SBMU.RETECH.1396.324
Health conditions studied
1
Description of health condition studied
Extra articular distal Tibia Fracture
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Evaluation of post operation complication due to approaches
Timepoint
Six weeks, 3 months, 6 months, and 12 months after surgery
Method of measurement
American Orthopaedic Foot and Ankle Society (AOFAS) Ankle Questionnaire
2
Description
Tscherne score
Timepoint
Six weeks, 3 months, 6 months, and 12 months after surgery
Method of measurement
Questionnaire
3
Description
Fracture type, according to AO classification
Timepoint
Once, at the beginning of the study
Method of measurement
Radiologic image
4
Description
Infection
Timepoint
Six weeks, 3 months, and 6 months after surgery
Method of measurement
Wound examination
Secondary outcomes
1
Description
AOFAS (Ankle score). This instrument combines functional outcome and pain.
Timepoint
Six weeks, 3 months, 6 months, and 12 months after surgery
Method of measurement
American Orthopaedic Foot and Ankle Society (AOFAS) Ankle Questionnaire
Intervention groups
1
Description
Intervention 1 group: patients have operated by posteromedial approaches in extra articular surgery
Category
Treatment - Surgery
2
Description
Intervention 2 group: Patients have operated by anteromedial approaches
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital, Tehran
Full name of responsible person
Mohammad Ali Okhovatpour
Street address
Taleghani Hospital, Arabi Ave, Daneshjoo Blvd., Velenjak, Tehran