Comparison of Augmented Platting and Exchange Nailing Methods in Treating Patients with nonunion Long Bone fractures
Design
The two groups of patients who will be randomly assigned through close envelops in order to undergo two different surgical treatment
Settings and conduct
All of the Patients with non-union of long bones will undergo surgery via either Augmented Plating or Exchange Nailing approach
Participants/Inclusion and exclusion criteria
Patients with nonunion long bone fractures
Intervention groups
Patients with non-union of long bone fractures who underwent either Exchange Nailing or Augmented Platting
Main outcome variables
Bone union duration
Surgical complication
Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181216042007N1
Registration date:2019-09-01, 1398/06/10
Registration timing:registered_while_recruiting
Last update:2019-09-01, 1398/06/10
Update count:0
Registration date
2019-09-01, 1398/06/10
Registrant information
Name
Pooyan Jalalpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4400 8273
Email address
p.jalalpour@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the two methods of Augmented Platting and Exchange Nailing in the treatment of patients with long bones nonunion fractures
Public title
Comparison of different methods for treating long bones nonunion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with nonunion long bone fractures
Exclusion criteria:
Atrophic non unions
Infected non-unions
Pathologic fractures
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
closed envelope:In this method, for each patient, for the selection of the treatment method, the closed envelopes are equal and the total number of patients, which is written in half of the total envelopes, is one of two treatments, and each patient is asked to choose an envelope.and give it to the surgeon to choose the type of treatment without seeing the contents
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants in the study and analyzer are unaware of how people are placed in the study groups
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