Comparing Two Treatment Methods For Fixation Of Closed Extra Articular Fractures Of 1/3 Distal Tibial Bone: Distal Lcp Fixation Vs Intramedullary Nailing
Background:
Locking Compression Plate (LCP) and intramedulary nailing (IMN) are two common methods of treatment for distal tibia fractures each having its advantages and disadvantages. The aim of the present study was to compare therapeutic results of these two methods on distal tibia fractures.
Material and methods:
Patients with closed extra-articular fractures of one third distal tibial bone were refferd to Imam Reza and Kamyab hospitals, included in this study. Herein, a clinical trial on 64 patients (aged 18 to 70 years) was performed in period of one year with patients randomly assigned to one of the IMN or LCP group. After the surgical management of the fracture, the average time of surgery, average time for callus formation, time required for full weight bearing, the need for second surgery, and the occurrence of surgical complications such as infection, mal-alignment, delay in callus formation, and device failure, were compared between the two groups. Data were analyzed using a student’s t-test and Chi square test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012081410596N1
Registration date:2012-12-10, 1391/09/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-12-10, 1391/09/20
Registrant information
Name
Farshid Bagheri
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1852 0028
Email address
bagherif@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2011-08-27, 1390/06/05
Expected recruitment end date
2012-11-25, 1391/09/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing Two Treatment Methods For Fixation Of Closed Extra Articular Fractures Of 1/3 Distal Tibial Bone: Distal Lcp Fixation Vs Intramedullary Nailing
Public title
Comparing Two Treatment Methods For Fixation Of Closed Extra Articular Fractures Of 1/3 Distal leg Bone : Distal Lcp Fixation Vs Intramedullary Nailing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with Closed Extra Articular Fractures Of 1/3 Distal Tibial Bone; male or female and age between 18 to 70 years old. Exclusion criteria: patients who have underlying diseases like diabetes, hepatic failure, renal failure, neurologic, rheumatologic and cardiopulmonary or cancer diseases; patients who have open tibia fracture; patients with pathological fractures; patients with intra articular fractures; patients who are less than 18 and more than 70 years old and patients who have osteoporosis with any cause.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
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
Mashhad University of Medical Sciences
Street address
Ghoreishi Department, Vice chancellor for research، Mashhad University of Medical Sciences, University Street
City
mashhad
Postal code
Approval date
2011-08-27, 1390/06/05
Ethics committee reference number
900056
Health conditions studied
1
Description of health condition studied
Closed Extra Articular Fractures Of 1/3 Distal Tibial Bone
ICD-10 code
S82.3
ICD-10 code description
Fracture of lower end of tibia
Primary outcomes
1
Description
time of union
Timepoint
2 weekly for one month and monthly for 5 months
Method of measurement
radiology
2
Description
time of surgery
Timepoint
time from begining to end of sugery
Method of measurement
minute
3
Description
time of weighting on foots
Timepoint
two weekly for one month and monthly for five months
Method of measurement
radiology and clinical examination
Secondary outcomes
1
Description
infection
Timepoint
Weekly
Method of measurement
visit-measurement of ESR & CRP
Intervention groups
1
Description
internal medullary nailing in intervention group
Category
Treatment - Surgery
2
Description
lcp plate in control group
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Kamyab hospital
Full name of responsible person
Street address
City
Mashhad
2
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Ghoerishi Dpartment, Vice chancellor for research, Mashhad University of Medical Sciences, University Street, Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Shahid Kamyab Hospital
Full name of responsible person
Dr Farshid Bagheri
Position
Assistant professor- member of faculty
Other areas of specialty/work
Street address
Mashhad
City
Mashhad
Postal code
Phone
+98 51 1852 0028
Fax
Email
bagherif@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Farshid Bagheri
Position
Assistant professor
Other areas of specialty/work
Street address
Mashhad
City
Mashhad
Postal code
Phone
+98 51 1852 0028
Fax
Email
bagherif@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
mashhad university medical of sciences
Full name of responsible person
Dr Farshid Bagheri
Position
assistant professor
Other areas of specialty/work
Street address
City
mashhad
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)