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Effects of Platelet Rich Plasma in Treatment of patients with Long Bones Non-unions: A Randomized Double-Blind Clinical Trial

Protocol summary

Summary
The aim of this study is to determine the effects of plasma rich platelet (PRP) on healing rate of long bones non-union. A total number of 70 adult (>18 years) patients suffering from long bones (Femur, Tibia, Fibula, Humerus, Ulna, Radius) with duration of more than 6 months will be randomly assigned to receive 5mL PRP (n=35) or 5mL placebo (n=35) in the site of fracture after intramedullary nailing or open reduction and internal fixation (ORIF). Those with infectious non-union, vascular injuries, malignancies, skin defects, metabolic bone disorders and platelet count<100,000/µL would be excluded. Patients would be followed each 45 days till 9 months and would be evaluated both clinically and radiologically. The healing rate, failure rate, incidence of infection, mal-union and limb shortening would be recorded and compared between groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201208262445N1
Registration date: 2012-09-23, 1391/07/02
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-09-23, 1391/07/02
Registrant information
Name
Fariborz Ghaffarpasand
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4259
Email address
ghafarf@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Trauma Research Center - Shiraz University of Medical Sciences
Expected recruitment start date
2011-05-01, 1390/02/11
Expected recruitment end date
2012-10-21, 1391/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Platelet Rich Plasma in Treatment of patients with Long Bones Non-unions: A Randomized Double-Blind Clinical Trial
Public title
Effects of Platelet Rich Plasma in Treatment of patients with Long Bones Non-unions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age>18 years; long bone non-unions (Femur, Tibia, Fibula, Humerus, Ulna, Radius) with duration of more than 6 months Exclusion criteria: Age<18 years; infectious non-unions; vascular injuries; large skin defects of fracture site; musculoskeletal disorders; malignancies; pathological fractures (tumors, metabolic osteopenia); active autoimmune disorders; large bone defects; platelet count <100,000 per micro-liter; treatment with growth factors within the previous years; treatment with steroids and NSAIDs during the previous year
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of AJA University of Medical Sciences
Street address
AJA University of Medical Sciences, West Fatemi Street, Etemadzadeh Street, Tehran
City
Tehran
Postal code
Approval date
2011-10-30, 1390/08/08
Ethics committee reference number
4920/51

Health conditions studied

1

Description of health condition studied
Nonunion of fracture
ICD-10 code
M84.1
ICD-10 code description
Nonunion of fracture [pseudarthrosis]

Primary outcomes

1

Description
Clinical cure rate
Timepoint
Postoperaive days 45, 90, 135, 180, 225, 270
Method of measurement
Physical examination

2

Description
Radiological cure rate
Timepoint
Postoperaive days 45, 90, 135, 180, 225, 270
Method of measurement
Anteroposterio and lateral radiography views

Secondary outcomes

1

Description
Incidence of infection
Timepoint
Postoperative days 45, 90, 135, 180, 225, 270
Method of measurement
Bacterial culture

2

Description
Muscular trophism
Timepoint
Postoperative days 45, 90, 135, 180, 225, 270
Method of measurement
Physcial examination

3

Description
Incedence of mal-union
Timepoint
Postoperative days 45, 90, 135, 180, 225, 270
Method of measurement
Anteroposterio and lateral radiography views

4

Description
Pain severity
Timepoint
Postoperative days 45, 90, 135, 180, 225, 270
Method of measurement
Visual Analogue Scale (VAS)

Intervention groups

1

Description
Injection of 5 milliliters of plasma rich platelet (PRP) in the site of operation and forming a fascia and closing the wound
Category
Treatment - Drugs

2

Description
Injection of normal saline in the site of operation and forming a fascia and closing the wound
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Chamran hospital
Full name of responsible person
Fariborz Ghaffarpasand
Street address
Shahid Chamran hospital, Chamran Avenue, Shiraz
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Trauma Research Center
Full name of responsible person
Shahram Paydar
Street address
Trauma Research Center, 2nd floor, Shahid Rajaei hospital, Chamran Avnue, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Trauma Research Center
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
Trauma Research Center, Shiraz University of Medical Sciences
Full name of responsible person
Fariborz Ghaffarpasand
Position
MD/ Researcher
Other areas of specialty/work
Street address
#103, Biat Alley, Shurideh Shirazi street, Shiraz
City
Shiraz
Postal code
7173646199
Phone
+98 71 1233 4477
Fax
Email
ghafarf@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
AJA University of Medical Sciences
Full name of responsible person
Mostafa Shahrezaei
Position
Orthopedic Surgen/ Assistant Professor
Other areas of specialty/work
Street address
AJA University of Medical Sciences, West Fatemi street, Etemadzadeh street, AJA University of Medical Sciences, Terhan
City
Terhan
Postal code
Phone
+98 21 8802 8355
Fax
Email
moshahrezayee@yahoo.com
Web page address
www.ajaumas.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Trauma Research Center, Shiraz University of Medical Sciences
Full name of responsible person
Fariborz Ghaffarpasand
Position
MD/ Researcher
Other areas of specialty/work
Street address
Shahid Chamran hospital, Chamran Avenue
City
Shiraz
Postal code
71345-1876
Phone
+98 71 1625 4206
Fax
Email
ghafarf@sums,ac,ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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