Protocol summary

Summary
This study was to compare the surgical outcomes of calcaneal fracture management ‎between the open reduction and internal fixation technique (ORIF) and the MIS ‎technique. In this randomized clinical trial, forty patients with calcaneus fractures were ‎randomly assigned to two equal groups; ORIF group and MIS group. Patients ‎were followed for 1 year post-operatively. Gissane and Bohler’s angles, ‎AOFAS questionnaire, pain intensity, ability to conduct previous activities and ‎various complications like wound healing complications and irritation with ‎shoe wear were assessed in the final post-operative visit. Eventually data ‎obtained from the two groups were compared. ‎ Inclusion criteria: fracture type II and III Sanders Exclusion criteria:presence of fractures especially at the foot of the same side; bilateral calcaneous fracture; multiple fractures; open fracture; Diabetes; Rheumatoid Arthritis; patients under the age of 15; fractures that occurred more than three weeks after it occurred.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017092720258N62
Registration date: 2017-10-29, 1396/08/07
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-10-29, 1396/08/07
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor and Research, Arak University of Medical Sciences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2017-11-22, 1396/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the minimally invasive surgical treatment outcomes of itra-extra articular calcaneal fracture’s and non operative treatment in valiasr hospital
Public title
Comparison of the minimally invasive surgical treatment outcomes of itra-extra articular calcaneal fracture’s and non operative treatment in valiasr hospital
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: fracture type II and III Sanders Exclusion criteria:presence of fractures especially at the foot of the same side; bilateral calcaneous fracture; multiple fractures; open fracture; Diabetes; Rheumatoid Arthritis; patients under the age of 15; fractures that occurred more than three weeks after it occurred
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Arak University Of Medical Sciences
Street address
Vice chancellor for research, Payambar azam complex, Basij squre, Sardasht, Arak
City
Arak
Postal code
38149578558
Approval date
2016-06-14, 1395/03/25
Ethics committee reference number
IR.ARAKMU.REC.1395.96

Health conditions studied

1

Description of health condition studied
Calcaneus fracture
ICD-10 code
S92.0
ICD-10 code description
Fracture of calcaneus

Primary outcomes

1

Description
Gissane and Bohler’s angles‎
Timepoint
After 1 years surgery
Method of measurement
Degree

2

Description
Functional level
Timepoint
After 1 years surgery
Method of measurement
AOFAS questionnaire

3

Description
Pain
Timepoint
After 1 years surgery
Method of measurement
Visual Analogue Scale Questionnaire

4

Description
Conduct previous activities ‎
Timepoint
After 1 years surgery
Method of measurement
Observation

5

Description
Various complications like wound healing complications ‎
Timepoint
After 1 years surgery
Method of measurement
Observation

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: This patient is surgery with open surgery.
Category
Treatment - Drugs

2

Description
Control group: patients treat with routin treatment.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Dr Alireza Amani
Street address
Valiasr Hospital, Arak
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences
Full name of responsible person
Dr Anoshirvani
Street address
Vice chancellor for research, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
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, Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Amani
Position
Faculty member
Other areas of specialty/work
Street address
Valiasr Hospital, Valiasr square, Shahid Shirodi street
City
Arak
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 863222003
Email
amani@arakmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Amani
Position
Faculty member
Other areas of specialty/work
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 863222003
Email
amani@arakmuaac.ir
Web page address
-

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Abdolvahid Shakeri
Position
resident of orthopedic
Other areas of specialty/work
Street address
Payambar Azam Complex, Basij Square, Sardasht, Arak
City
Arak
Postal code
3814957558
Phone
+98 86332222003
Fax
+98 863222003
Email
Shakeri@arakmu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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