A clinical trial comparison of two methods of transpatellar and parapatellar for anterior knee pain after intramedullary nailing for patients with fractures of tibial shaft
Objectives: Comparison of two methods of transpatellar and parapatellar for anterior knee pain after intramedullary nailing of fractures of tibial shaft. Design: patients with fractures of tibial shaft, two groups by method of transpatellar and parapatellar, 68 patients, single-blind, randomized, single-center, phase II trial. Setting and conduct: Nailing with method of transpatellar and nailing with method of parapatellar is placed randomly into two groups. Severity of pain is evaluated according to VAS criteria during one month and six month after surgery. Participants including major eligibility criteria: Inclusion criteria include patients undergoing fractures of tibial shaft for intramedullary nailing; exclusion criteria include lack of fractures of tibial shaft for intramedullary nailing. Intervention: Nailing with method of transpatellar in first intervention group and nailing with method of parapatellar in second intervention group. Main outcome measures variable: Severity of pain is evaluated according to criteria of VAS.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016020926474N1
Registration date:2016-03-26, 1395/01/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-03-26, 1395/01/07
Registrant information
Name
Akbar Sangari
Name of organization / entity
Ahvaz Jondishapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 5133
Email address
sangari.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jondishapour University of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial comparison of two methods of transpatellar and parapatellar for anterior knee pain after intramedullary nailing for patients with fractures of tibial shaft
Public title
Comparison of two methods surgery of locking intramedullary nailing for tibial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients undergoing fractures of tibial shaft for intramedullary nailing; age more than 15 years; diaphyseal fracture of the tibia. Exclusion criteria: lack of fractures of tibial shaft for intramedullary nailing; diabetic; safety defects; immunodeficiency; ulceration at the entry point nail; previous fractures and chronic pain in front knee before fracture.
Age
From 15 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 of Ahvaz Jondishapour University of Medical Sciences
Street address
Vice chancellor for research, Centeral of Ahvaz Jondishapour University of Medical Sciences, City of University
City
Ahvaz
Postal code
61357-15794
Approval date
2016-01-23, 1394/11/03
Ethics committee reference number
ir.ajums.rec.1394.585
Health conditions studied
1
Description of health condition studied
Fractures of Tibial Shaft
ICD-10 code
S82.2
ICD-10 code description
Fracture of shaft of tibia
Primary outcomes
1
Description
Pain after nail placement
Timepoint
1 month and 6 months after nail placement
Method of measurement
According to the VAS scale
Secondary outcomes
empty
Intervention groups
1
Description
Nailing by method of transpatellar
Category
Treatment - Surgery
2
Description
Nailing by method of parapatellar
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Akbar Sangari
Street address
Golestan Hospital, Farvardin Avenue
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jondishapour University of Medical Sciences
Full name of responsible person
Nader Saki
Street address
Vice chancellor for research, Central of Ahvaz Jondishapour University of Medical Sciences, City of University
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jondishapour 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
Golestan Hospital
Full name of responsible person
Hamid Reza Arti
Position
Head of Golestan Hospital
Other areas of specialty/work
Street address
Golestan Hospital, Farvardin Avenue
City
Ahvaz
Postal code
61357-15794
Phone
+98 61 3374 3014
Fax
Email
golestanhospital@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jondishapour University of Medical Sciences
Full name of responsible person
Abdolhosein Mehdinasab
Position
Orthopedic specialist
Other areas of specialty/work
Street address
Golestan Hospital, Farvardin Avenue
City
Ahvaz
Postal code
Phone
+98 833743001
Fax
Email
hmehdinasab@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jondishapour University of Medical Sciences
Full name of responsible person
Akbar Sangari
Position
Assistant of orthopedic
Other areas of specialty/work
Street address
Golestan Hospital, Farvardin Avenue
City
Ahvaz
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)