Objective: Comparison between conventional and minimally invasive techniques for treatment of calcaneal fracture. Design:36 patients with calcaneal fracture admmitted in shahid kamyab hospital will randomly divide into two groups using randomization table software. Participants: Patients with calcaneous fractures aged between 18 and 75 years excluding patients with open fracture. Intervention: In the first group 18 patients will operate using conventional large L type incision on the lateral surface of the ankle and in the second group the surgery on 18 patients will perform using 3 centimeters incision on the sinus tarsi region. Primary outcomes: Accuracy of reduction detected by measurement of Bohler and Gissane angles on the lateral radiography of the ankle and reduction of the articular surface on the coronal CT scan of the ankle; Functional assessment using VAS, AOFAS and SF36 questionaires 6 and 12 months after the surgery; Rate of wound infection and dehiscence. Secondary outcomes: Rate of malunion and non-union of the fracture that will detect on plain radiographs and ankle CT scan.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016051327872N1
Registration date:2017-07-17, 1396/04/26
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-07-17, 1396/04/26
Registrant information
Name
Sayyed Hadi Sayyed Hosseinian
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 2121
Email address
hoseinianh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2018-01-21, 1396/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between conventional and minimally invasive technique for treatment of calcaneal fracture.
Public title
Comparison of two surgical techniques for treatment of calcaneal fracture.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion critaria: calcaneal close fracture; age more tha 18 years and less than 75 years , exclusion critaria: open calcaneal fracture; no indication for surgical treatment; uncontrolled systemic diseases; simultanous foot fracture
Age
From 17 years old to 74 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences, Research Deputy, Commitee of Ethics
Measurement of the Bohler's and Gissane angles on lateral radiograph and articular surface reduction on coronal CT scan of the ankle
Secondary outcomes
1
Description
Non-union
Timepoint
6 months and one year after the surgery
Method of measurement
On the plain radiographs and CT scan of the ankle
2
Description
Malunion
Timepoint
6 months and one year after the surgery
Method of measurement
Using plane radiographs and CT scan of the ankle
Intervention groups
1
Description
In the intervention group calcaneal fracture will operate through the minimally invasive approach by using a 3 centimeter incision on sinus tarsi. After exposing the articular surface by removing the adipose tissue and retracting the extensor digitorum brevis muscle, reduction of the fracture will done and primarilly fixed by a pin and then by a screw the the fracture will finally fix with a small plate.
Category
Treatment - Surgery
2
Description
In the control group the surgery will perform using a large L type incision on the lateral aspect of the ankle and soft tissues including peroneal tendons will subperiosteally retract anteriorly the fracture and articular surface will expose and the reduction of the articular surface will be obtained and fixed by a screw and then fracture will fix with a large calcaneal plate.