Evaluation of the effect of digital monitoring system on weight-bearing of patients undergoing orthopedic lower extremities surgery on surgical success
The aim of this study was to determine the effect of using an intelligent monitoring system with cane or shoe a sensor in comparison with a cane and shoes without a sensor on the success of surgery with patient weight-bearing.
Design
This study was a parallel randomized controlled trial study design. The sample size of the study is 216 patients that will be assigned to intervention and control groups using simple randomization method.
Settings and conduct
Evaluation of patients' outcomes is in the 1st, 2nd and 3rd months after surgery with radiography. This study will be performed in the orthopedic ward of Rasoul Akram Hospital of Iran University of Medical Sciences. Because the intervention processes are well known in the groups, both the patient and the treating physician are aware of the interventions, so the blind groups in this study were considered final outcome evaluators and data analyzers.
Participants/Inclusion and exclusion criteria
The main inclusion criteria are patients with orthopedic surgery of the lower extremities and over 18 years of age, and the non inclusion criteria can be referred to having an infection.
Intervention groups
All patients undergoing lower extremities surgery will be used cane and shoes to weigh-bearing.Only in the intervention group will be used shoes and canes with a sensor that records the amount of permissible and impermissible weight-bearing by the patient with the help of a monitoring system.
Main outcome variables
Callus formation; Postoperative infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220304054177N1
Registration date:2022-03-09, 1400/12/18
Registration timing:prospective
Last update:2022-03-09, 1400/12/18
Update count:0
Registration date
2022-03-09, 1400/12/18
Registrant information
Name
Sahand Cheraghiloohesara
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2214 8261
Email address
sahand.cheraghi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-19, 1400/12/28
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of digital monitoring system on weight-bearing of patients undergoing orthopedic lower extremities surgery on surgical success
Public title
Evaluation of the effect of digital monitoring system on surgical success
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with joint replacement surgery
Patients with fracture surgery
Patient willingness to participate in the study
Exclusion criteria:
Having an infection
Unavailability of the patient for follow-up
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
216
Randomization (investigator's opinion)
Randomized
Randomization description
After the participants were selected to study, we will use simple randomization method to assign participants to the groups for received intervention and comparison. The randomization process will be performed using Random Allocation software, and since this study consists of two groups, the allocation outputs of the participants will be identified by A and B so the assign of each patient in each group is unpredictable to other members of the research team. We will notify for the team manager after selecting each patient and they will determine the type of group each person according to the software output.
Blinding (investigator's opinion)
Double blinded
Blinding description
Double blinding was considered for this study. Due to the different process of interventions in the study groups, the patient outcome assessor and data analyzer will be blinded of the type of patient interventions.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2022-02-22, 1400/12/03
Ethics committee reference number
IR.IUMS.REC.1400.1117
Health conditions studied
1
Description of health condition studied
Orthopedic postoperative care
ICD-10 code
Z47.8
ICD-10 code description
Other specified orthopaedic follow-up care
Primary outcomes
1
Description
Callus formation
Timepoint
Three months after surgery
Method of measurement
Radiography
2
Description
Postoperative infection
Timepoint
Monthly postoperative examinations for three months
Method of measurement
Physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients who use a digital weight-bearing control device embedded on a cane or shoe after lower extremities orthopedic surgery.
Category
Rehabilitation
2
Description
Control group: Patients who use a ordinary cane or shoes after lower extremities orthopedic surgery.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram hospital
Full name of responsible person
Mehdi Moghtadaei
Street address
Rasoul Akram hospital, Niyayesh St, Sattarkhan St.
City
Tehran
Province
Tehran
Postal code
1465613131
Phone
+98 21 6435 9260
Email
mmoghtadaei@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hossein keyvani
Street address
Iran University of Medical Sciences, Shahid Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
research-m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Alireza Amanollahi
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Rasoul Akram hospital, Niyayesh St, Sattarkhan St.
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6653 9260
Email
amanollahi.a@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mehdi Moghtadaei
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Rasoul Akram hospital, Niyayesh St, Sattarkhan St.
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6653 9260
Email
mmoghtadaei@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sahand Cheraghi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Rasoul Akram hospital, Niyayesh St, Sattarkhan St.
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
009866539260
Email
sahand.cheraghi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Finding of the study, demographic data of participants in the study, in addition to descriptive and analytical analysis of variables.
When the data will become available and for how long
Availability six months after the end of study
To whom data/document is available
Orthopedics
Under which criteria data/document could be used
Anyone who has a request for information about the results of this research
From where data/document is obtainable
Iran University of Medical Sciences
What processes are involved for a request to access data/document
By referring to the central library and clinical trial center in Iran University of Medical Sciences can access to the documents of participants, data and results.